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collegeeducationnewsllcusa · 3 years

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2021 MBAs To Watch: Gráinne Dunne. Boston College (Carroll)

“Loyal and pragmatic with a thirst for adventure.”

Hometown: Athy, Ireland

Fun fact about you: I’m on a mission to visit all 63 national parks in the United States. I’ve visited 10 since moving to the US.

Basic studies and degree:

Trinity College Dublin, Bachelor of Science (Pharmacy)

Royal College of Surgeons, Master of Science (Pharmacy)

Where was the last place you worked before enrolling in business school? I worked in Operations at AbbVie, where I led a team of 13 pharmaceutical technicians at a drug manufacturing facility.

Where did you do an internship in summer 2020? PwC, Chicago / Remote.

Where will you work after you graduate? I have accepted an offer from PwC and will return to their Pharma Life Sciences Advisory Group after graduation.

Teamwork and leadership roles in the business school: As part of my community ministry at Boston College, I volunteer as a tutor on the Invest ‘N Kids (INK) program. INK is run by PhD students as a tutoring program designed to help disadvantaged middle school students with their homework.

I also volunteer at the West End House. This is the largest youth development agency in the Allston-Brighton community in Boston, offering impactful programs that ensure local young people are academically successful, develop professional skills, and adopt healthy lifestyles.

As a member of the Graduate Consulting Club, I took part in workshops and mentored a group of first-year MBA students. I’ve also participated in several case competitions. I worked with the admissions team in recruiting prospective students and acted as an ambassador for the program at information events.

I am a member of IntEnt, the Graduate Intrapreneurship & Entrepreneurship Association at Boston College. I participated in the IntEnt Apprenticeship Program, a volunteer opportunity that connects Boston College graduates with local Boston organizations.

I am a recipient of the Denis O’Brien Fellowship. Irish businessman Denis O’Brien created this merit-based scholarship, which offers two Irish students a year a fully funded MBA in BC, where O’Brien himself earned his MBA in 1982.

What school or extracurricular achievement are you most proud of during your studies? I am proud of how my relationship with the church has changed, inspired by the Jesuit tradition of service at Boston College. A strong sense of community was instilled in me. I don’t think I really understood before business school that individuals rarely change needles on big issues, but there is great power in having individuals consistently support their community. This is a change of perspective for which I am very grateful.

What success in your professional career are you most proud of? Working with an innovative biotech company like AbbVie offered excellent opportunities for exciting and meaningful work. As a Technical Operations Pharmacist, I was responsible for the technical transfer of a new oncological drug from pilot to commercial scale. It’s incredible to work on projects that have such a real impact on the lives of patients around the world. I was also the supply chain representative on the rollout team for a new hepatitis C (HCV) treatment at the rollout manufacturing site. Prior to the introduction of this therapy, there was no cure for HCV. Treatment at the time required long-term maintenance and was incredibly debilitating. AbbVie’s HCV treatment cleared the virus from your body within 12 weeks, allowing patients to live full and healthy lives.

Why did you choose this business school? Boston College has a very strong data analytics track – that was very important to me when choosing a program. I really enjoyed mastering data tools like SQL, Tableau, SPSS, Alteryx, and Python and learning how to use these tools for strategic insights. These are skills that will set me apart in the workplace.

Boston College has a deep connection to Ireland and a great sense of community, which makes it a special experience for me and where I feel very at home.

What was your favorite MBA event or tradition at your business school? The Tuck Winter Carnival, an annual intercollegiate event that BC is invited to, was my favorite MBA event – especially since it happened just before last year’s lockdown. I was fortunate enough to take part as a freshman MBA student. It was great not only getting to know MBA students from other schools, but also building stronger connections with my classmates and high school students.

Looking back on your MBA experience, what would you do differently and why? There isn’t much that I would change. I was hoping to go on a volunteer trip. With the lockdown, however, this was not possible. Otherwise, I might have changed a course or two afterwards. However, by dealing with various topics, I was able to understand my personal interests, strengths and weaknesses.

What’s the biggest myth about your school? Boston College is known as a strong financial school. That’s true, but the BC MBA also has a broad curriculum and we are fortunate to have very talented professors everywhere. For example, we have an incredibly strong data analytics track. Professors like Pieter Vanderwerf, George Wyner, Sam Ramsbottom and Jonathan Reuter make their respective fields accessible, practical and entertaining.

What surprised you most about the business school? I was surprised that I liked the more technical and quantitative subjects, although I am probably qualitatively stronger. There is a great sense of satisfaction in tackling a difficult problem and overcoming the challenge.

What did you do during the application process that gave you an advantage at the school you chose? A face-to-face visit to a school and a face-to-face meeting with faculty and students is invaluable, not only to give you an edge during the application process, but also to determine if the school is a good culturally fit for you.

Which MBA classmate do you admire most? Kimberly Hay Strauss is remarkable. She is always up to date in class while doing internships and looking after her son during school time. Despite her humble, low-key style, it is evident that she is incredibly intelligent and hardworking. She is also very generous with her classmates.

How disruptive was switching to an online or hybrid environment after the COVID outbreak?

The pandemic was certainly a shock and the MBA experience was one of many things that were hit by these unprecedented times. Regardless, BC and the professors did a great job adapting to an online environment quickly and providing personal support to the students. I also took the opportunity to get the most out of the online MBA experience by setting up zoom workouts in the morning, using virtual office hours, and making daily check-in calls with my friends. I was incredibly grateful that I had the opportunity to build relationships with my fellow students in the first semester. That was a great support network.

Who most influenced your decision to start a business while studying? Several people inspired and influenced my decision to do business while in college. My father is my role model. He is a serving leader within the local community. He set high standards for my siblings and me and taught us to do our best in everything we did. He instilled in us the confidence that great opportunities are open to us.

My younger sister is a trained pharmacist and also attended business school. She is a health counselor and opened my eyes to the impactful work available to those who can marry a health and business perspective.

James Hughes, a director at AbbVie, taught me a lot about strategic thinking and how to effectively support and engage a team. He is a great mentor who has actively supported my personal development and professional career.

What are the top two items on your professional bucket list? In the short term, I’m excited to come to PwC to work with life science clients to solve their greatest challenges. I am interested in building based on my data analysis skills that I acquired at BC. This is in line with PwC’s goal of training its employees with new data tools. Ideally, I want to help companies design and leverage data systems to achieve operational efficiencies and improve the overall patient experience.

In the long term, I would like to start my own company. Ideally, I want to start a small or medium-sized business that offers job opportunities or drives growth in my community.

What did … do Gráinne such an invaluable addition to the 2021 class?

“Gráinne has the ideal qualities that we expect from a BC MBA student. She is smart, hardworking, and dedicated to giving back to the community. Her exemplary achievements and contributions at BC – in the classroom and her work with Invest N ‘Kids, in her summer internship and at BC MBA admissions events – testify to her consistent pursuit of excellence.

Born and raised in Ireland, Gráinne attended Trinity College, where she earned both a BS and an MS in pharmacy. After graduation, she was hired by AbbVie, the Illinois-based pharmaceutical company, to work on the company’s business development program in Dublin, Ireland. Because of the high quality of her work, she was given the opportunity to work at AbbVie’s Chicago office.

Gráinne applied to the Carroll School, where she received the highly selective Denis O’Brien Scholarship, which is awarded to students expressing an interest in the economy or business development in Ireland. After a successful first year in the program, Gráinne completed the consultant internship program at PwC in Chicago in the summer of 2020 and will return there for a full-time position after graduation. We have been fortunate to have Gráinne as a member of the 2021 class and she is a real pleasure to work with. In addition to all of her successes in the program, Gráinnes’ humility and her commitment to the BC MBA program make us proud to have her as a member of our community. “

Marilyn Eckmann Associate Dean, Graduate Program, Carroll School of Management

source https://collegeeducationnewsllc.com/2021-mbas-to-watch-grainne-dunne-boston-college-carroll/

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ccrpsorg · 4 years

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Clinical Research Associate Training Guide

Why Become a Clinical Research Associate?

CCRPS is one of the only major US-based ACCRE, ACCME, ANCC, ACPE, and Transcelerate Biopharma accredited CRA certification courses that accepts students with no prior background for certification. This is because our course is thorough and created by Senior CRAs who have been in the field for long enough to understand what you need to know to begin working and applying. The course can be completed in as little as 7 days with dedicated full-day study time.

Nonetheless, for those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career. Because the position is unlike actually working in the lab and requires a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.

Best of all; many of these positions accept remote staff (and some allow you to travel 45-75% with full expenses including travel, accommodation, meals, and other per-dime expenses covered). Clinical Research Training can help you save money while also increasing your salary. CRA’s with our level of training can expect to make between $6,500-$12,000 a month with an estimated promotion rate of 33% a year; an amount that is not common in other science-degree careers.

Many CRA students are actually matriculated foreign doctors who opted not to take the USMLE or repeat their residency training. In fact, some of our Clinical Research Training Students come to us immediately after moving to the U.S. and questioning what to do with an MBBS degree in US.

Unlike what you’ve learned during your 3-8 years in university or graduate school; the information needed for Clinical Research Training after your degree. Is rarely a repetition of any course you’ve taken before and thus we have 110 Clinical Research Training modules (more than any other course available) to make you get the position you want as a CRA.

2. Clinical Research Associate Certification Qualifications

Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online to start a career in the frontiers of medical research and patient care. As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or just did not meet your expectations for your science degree. This is why a career as a CRA should be considered with clinical research coordinator training. We train over 100 students each month in clinical research coordinator training and clinical research associate training (depending on prior background).

A Clinical Research Associate or Coordinator directs and supervises clinical trials that are run by physicians, nurses, and other science-degree holders. Unlike the jobs you currently can apply to on the market, a position as a CRA is actually much more difficult to obtain. While many generic courses exist on the market; we have seen that many of these students cannot find a job afterwords because of the lack of content depth. This is why our course offers a Senior Clinical Research Associate level of training with 110 intense modules. This science-based medical position is now a high-demand job which can be done privately for pharmaceutical companies such as Pfizer, or academically in medical schools. We have the largest number of clinical research courses online.

3. Why Take a CRA Certification Course

The role of the clinical research associate is very important in clinical trials to ensure that medical devices, new treatments and new drugs are approved for patients' use.

This field is taken as a certificate program course in many schools. You may also discover the availability of associate degree programs depending on the school. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.

If you opt for an online program, different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as with the lecturers. Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.

These certificate programs are generally designed for professionals that are already in the medical fields like medical assistants, nurses etc, and are interested in moving to the field of clinical research. They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.

Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials. During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.

The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective, the need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience of clinical trials. Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.

In applying for the post of a clinical research associate, ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to. Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies, you might get more chance with that.

Further certification can enhance your resume such as the ACCRE accredited CRA program which contains 110 learning modules for Clinical Research Associate Training and Placement

4. The Best CRA Certification Course for Entry-Levels

CCRPS Course covers double to triple the amount of course content than other courses. While many courses are simply 5-20 simple interactive modules, our course covers 140 dense modules in thorough detail. After each session, students can ask their questions privately with the course instructor, all of whom have 15+ years of CRA experience. We offer clinical research courses distance learning.

There is a huge shortage of well-trained CRAs, but many companies are reluctant to hire untrained entry-level clinical monitors because of patient and trial safety. Because of this, even the beginner entry-level jobs require certification or training. Most courses provide very light training that may look good because of the company names, but alone is not sufficient to pass the interview rounds a company conducts. Because we prepared our modules to stand by you even as a Senior Clinical Research Associate, we find more of our students with no background quickly passing their interview rounds. Our program is considered one of the top clinical research graduate programs online.

Currently, 82% of our students are hired within the first month of taking the course. Students with limited background or those looking to gain extra experience are offered a remote internship of up to 6 months during the time they are interviewing. This advantage allows many students with limited experience to get hired with a higher paying job than previously offered. For exam, nurses are offered our clinical research nurse training and can additionally take our clinical research management training.

While a majority of our students are physicians, a majority of the CRA workforce are Science Grads and Nurses. We train at a Senior CRA level for all students regardless of background because clinical research monitoring is vastly different from any lab or science course you may have taken. Clinical research associates are given the protocol of a study including all medical protocol that must be followed but because they do not diagnose or treat, the medical knowledge is supplemental but not sufficient in this career path. This is the main reason why our Clinical Research Training includes all possible scenarios you may face at the protocol and guideline level in your future company.

5. How to get Experience for Clinical Research Associate Jobs

Learn about our partnerships with dedicated clinical research recruiters by inquiring. We provide an 8 module job application preparation section in our CRA certification course.

CCRPS, like other educational institutes, is only associated with educating and certifying clinical research professionals so we do not provide job placement. We want to make sure you apply with your best foot forward. Below are links we readily refer to graduates who are looking for job support. Having a great CV and cover letter are essential to applying for jobs. Recruiters are paid by the company which hires you and thus are free for searching employees. Be realistic but also be driven. Make sure you get continue reaching out until you get a true rejection from any job you apply to as they may never have seen your application if you received no response.

Clinical Research Job Advising: Kunal at ClinicalTrialPodcast

Free Resume Review: TopCV TopCV provides a free review and feedback for your current resume.

Resume Distribution: ResumeRabbit Resume rabbit distributes your resume to 60 job posting sites.

Clinical Research Recruiters: I-Recruit I-Recruit distributes your resume to clinical research recruiters.

Clinical Research Job Bulletin: Indeed Indeed usually provides the most uptodate job bulletin for clinical research jobs

Always use a cover letter specific for the company and job when applying if you are not using a recruiter.

Clinical Research Associate Certification

Receive more information about the course by speaking with our 24/7 chat and phone advisors right now.

ICH GCP TRAINING

The ICH GCP training modules go over the entire ICH GCP guidelines in detail. They teach you how to apply them rather than just understand the protocols. This is the essential basis of Clinical Research Training.

15 MODULES

1. An Introduction to Clinical Research

2. An Overview of ICH GCP

3. Code of Federal Regulations

4. FDA 21 CFR Part 11 ( Part 1 and 2)

5. ICH GCP E6 Section 5 - Sponsors Responsibilities

6. ICH GCP E6 Section 4 - Investigators Responsibilities

7. ICH GCP E6 Section 4 - Investigators Responsibilities – Informed Consent Form

8. Reporting Responsibilities of the Investigators

9. Ethics of Research Involving Children

10. Ethics of Research Involving Mentally Incapacitated

11. Ethics of Research Involving Pregnant Women and Fetuses

12. Ethics of Research Involving Prisoners

13. ICG GCP 5.5 Trial Management – Data Handling and Record Retention

14. ICH GCP E6 and E2A - Adverse Events

15. Safety of Human Subjects in Clinical Research

Reference Modules - to be used for reference purposes only:

a) Common Terminology Used In Clinical Research

b) Commonly Used Abbreviations and Terms in Clinical Research

QUALITY MONITORING

The quality monitoring modules are needed to work as a supervisor on clinical trials. This is the section not available in any other entry or introductory clinical research training course with more detail than many new Senior CRAs know. These modules allow you to obtain the application, examples, and guidelines needed to monitor trials with ease in your new position.

45 MODULES

1. Duties and Responsibilities of a Clinical Research Associate

2. Designs of Clinical Trials

3. Phases of Clinical Trials

4. Pre-Clinical Trials

5. Stakeholders in Clinical Research and Their Relationships

6. Contract Research Organization- CRO

7. Randomized Controlled Trials

8. Types of Monitoring Visits

9. Site and Investigator Selection

10. Site Qualification Visit

11. Routine Monitoring Visit

12. Monitoring Tools and Notes

13. Checklists for Pharmacy Monitoring and Inspection Visits

14. Site Close Out Visit

15. Source Documents

16. Inclusion Exclusion Criteria in Clinical Research

17. Interactive Voice Response System - IVRS

18. Protocol in Clinical Research

19. Protocol Deviations and Violations

20. Institutional Review Board

21. Quality Control in Clinical Research

22. Data Safety Monitoring board- DSMB

23. An Overview of Remote Monitoring

24. Centralised Versus Onsite Monitoring

25. Electronic Data Capture and Remote Data Capture Basics

26. Remote Monitoring of Clinical Trials and EMRs

27. Blinding in Clinical Trials

28. Communication between Blinded and Unblinded Staff

29. Investigational Product Storage and Dispensing

30. Investigational Product Accountability in Clinical Trials

31. Adverse Drug Reactions

32. Basics of Adverse Event Monitoring

33. Adverse Event Reporting

34. Risk Based Monitoring

35. Pharmacovigilance (Part 1)

36. Pharmacovigilance (Part 2)

37. Safety Reporting Requirements for Sponsor Investigators

38. Investigator Initiated Multi Center Trails

39. IND and NDA Process

40. Guidelines for Designing and Completing Case Report Forms

41. Do’s and Don’ts of a Case Report Form Design

42. Introduction to Bioresearch Monitoring (BIMO)

43. Clinical Trial Management System-CTMS

44. Minimising Source Data Queries in Clinical Trials

45. Role of Local and Central Labs in Clinical Trials

REGULATORY TRAINING

Regulatory training allows you to understand and apply the FDA regulation guidelines to each individual trial you will supervise after your Clinical Research Training.

15 MODULES

1. Regulatory Documents in Clinical Research

2. Regulatory Affairs

3. Essential Regulatory Documents Guidance and Binder Tabs -Part 1

4. Essential Regulatory Documents Guidance and Binder Tabs - Part 2

5. Electronic Regulatory Submission and Review

6. Financial Disclosure- Duties and Strategies for Clinical Studies

7. Financial Disclosures and Conflicts of Interest in Clinical Research

8. FDA Form 1572 - Part 1

9. FDA Form 1571 - Part 2

10. Delegation of Authority Log – DOAL

11. Investigators Brochures

12. Protocol Continuing

13. IND Application

14. Trial Master File Reference Guide

15. Trial Master File and DIA Model

AUDIT AND INSPECTIONS

The auditing and inspections modules train you to prepare clinical trials for auditing by your company, government organisation, or academic organisation after your Clinical Research Training.

SUBJECT RECRUITMENT, RETENTION AND COMPLIANCE

5 MODULES

1. Compliance Requirements in Clinical Trials

2. Subject Recruitment and Retention (Part 1 and Part 2)

3. Increasing Subject Compliance in Clinical Trials

4. Ethical Consideration Associated with Investigator Payment and Patient Recruitment

5. Advertisement aid in Subject Recruitment and Retention6 MODULES

1. Audits and Inspections in Clinical Trials

2. FDA Warning Letter

3. Site FDA Audit Inspection Checklist

4. How to Survive Through an FDA Inspection

5. Do and Don’ts during an FDA Inspection

6. Mock FDA Audits

MISCONDUCT AND FRAUD

2 MODULES

1. Scientific Misconduct in Research and How to Prevent It

2. Misconduct in Research – Detecting Falsification

WRITING QUALITY MONITORING REPORTS & FOLLOW UP LETTERS

These modules immerse you in understanding, applying, and learning to write monitoring reports, follow up letters, and professional write-ups required in the CRA position after each clinical site visit or review after your Clinical Research Training.

16 MODULES

1. Site Monitor Transition Letter

2. Checklist of Activities for Pre-Study Visit Qualification

3. Pre-study Visit Assessment and Monitoring Questionnaire

5. Pre-Study Visit Follow Up Letter

6. Site Initiation Visit Agenda

7. Site Initiation Visit Confirmation Letter

8. Site Initiation Visit Report

9. Site Initiation Visit Follow Up Letter

10. Site Monitoring Visit Confirmation Letter/Fax

11. Site Monitoring Visit Report

12. Site Monitoring Visit Follow Up Letter

13. Site Close Out Visit Confirmation Letter

14. Site Close Out Visit Agenda

15. Site Close Out Visit Report

16. Site Close Out Visit Follow Up Letter

COMPETENCY TESTING FOR A CRA

The competency testing of your Clinical Research Training modules is the next step needed to ensure that you are ready for your interviews. We establish our CRA’s as future leaders in the clinical trial industry by ensuring you have the full education needed to be promoted in your career quicker than without the course.

CRA Certification Modules also cover the following roles:

CLINICAL RESEARCH COURSES

Below are our ACCRE accredited clinical research certification programs:

While several careers exist with a science degree, the best exposure to a medical career with a science bachelors is through Clinical Research Training. This can be taken as early as your senior year of college to prepare for a job directly out of university.

CRA positions right out of undergrad are nearly impossible to get due to the yearly 1.9 million graduates of science degrees (and approximate 2,000 applications per position). This is why Clinical Research Training is an essential investment in your career.

CRA positions after hiring will cover the expenses of travel, housing, food, and more if visiting clinical sites. Most pay $6.5-12k a month with the potential to move on to a CRA position after 2 years.

While many positions will fund or reimburse your CRA training; securing an initial position is the tough part. This is why our Clinical Research Training provides 110 clinical research training modules and interview preparation with a Senior CRA and Physician of 25 years.

Our Clinical Research Training makes almost anyone interested in making use of their science degree in medicine possible. We take on students with no medical background to full-on doctors looking for a better position due to their international medical degree.

We also offer private Principal Investigator Training for practicing physicians.

See available positions here to understand why CRA certification is essential to obtaining a career in medicine with a science degree.

CLINICAL RESEARCH ASSOCIATE CERTIFICATION

Online modules and competency exam with 60 day period of completion - Use to enhance knowledge for promotion to CRA, SrCRA, or other management levels in clinical trials. Can be taken by physicians, nurses, and bachelors, masters, and PhD graduates. No clinical research background required for enrollment and certification.

ICH GCP CERTIFICATION

Online modules and competency exam - No clinical research background required. ICH GCP certification is required by all jobs working with clinical trials.

CLINICAL TRIALS ASSISTANT CERITIFCATION

Online modules and competency exam - Minimum of high school degree or GRE is required. Use for jobs that require clinical trials experience and knowledge. No clinical research background required

CLINICAL RESEARCH MONITOR CERTIFICATION

Online modules and competency exam - No clinical research background required. Bachelors degree required.

CLINICAL RESEARCH NURSE CERTIFICATION

Online modules and competency exam - No clinical research background required. RN or BSN required.

FOR CLINICAL RESEARCH ASSOCIATE ENTRY LEVEL TRAINING

Learn about the PayScale and promotion methods for Clinical Research Associates by scrolling below.

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kentbea154743412-blog · 6 years

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