Fellowship in the area of Clinical Research

Are you interested in performing study coordinator type responsibilities at a clinical research site and getting hands on experience to advance your career?  

 

As part of the New Jersey Alliance for Clinical and Translational Science (a NIH CTSA hub), the Rutgers School of Health Professionals MS Clinical Research Management Program is accepting applications for  a Fellowship in the area of Clinical Research (No other MS program offers such an exciting opportunity).  This is a 6 month fulltime paid position ($25,000 to be paid over the 6 months) to gain hands on experience in the area of clinical research. The opportunity will be located at one of the Rutgers Biomedical Health Sciences campuses (Newark NJ or Piscataway NJ – depending upon the site selected by the program).

 

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Eligibility Requirements
  • graduated from our program with a MS Clinical Research Management within the last year or will be graduating at the end of August 2021 term
  • cumulative GPA of 3.0 (with no Academic Integrity issues).
Summary of Responsibilities

This learning experience will strengthen the fellows’ abilities to bridge classroom training and hands on experiences in order to comprehensively address the development of a clinical research professional. The fellow will:

  • be mentored by the directors of the CRUs and receive on the job training.
  • be assigned to one or more studies and would support the investigators and their teams.
  • gain leadership and professionalism skills through participation in monthly seminars, round table discussions and journal clubs.
  • be exposed to onsite procedures as it relates to initiating and close-out of sites, screening of patients for inclusion and exclusion criteria, administering informed consent, preparation of documents for IRB, maintaining trial master files, adverse event review, and eCRF review.
  • be responsible for preparing and presenting  training to site personnel on an aspect of what they learned.
  • be encouraged to involve themselves in scholarship activities which would lead to an abstract for presentation at Rutgers Research Day

At the beginning of each fellowship a list of deliverables will be identified and agreed upon with each fellow for which they will need to complete during their 6 month fellowship.

Meet Alene Mathurin-Gervais

2021 NJ ACTS Clinical Research Management Fellow

 

Alene Mathurin-Gervais, MS
2021 Clinical Research Management Fellow

Alene Mathurin-Gervais, MS is completing a 6-month NJ ACTS Clinical Research Management Fellowship at the New Jersey Medical School “Research with a Heart” Unit. The Workforce Core recently spoke with Alene to learn more about her journey and career development. Tap the topics below to find out what we learned:

Previous experience

Alene graduated from Rutgers University with a Bachelor of Arts degree in psychology and a minor in public administration. She is a certified life coach and holds a Master of Science degree from the Rutgers School of Health Professions where she was able to build real-world, hands-on experience in clinical research, specifically community engagement practices, which further bolstered her interest in clinical and translational science.

Inspiration

Mathurin-Gervais decided to apply for this fellowship opportunity because her Program Director, Dr. Doreen W Lechner, has been a major advocate as a mentor. She states, “I wanted to use research for the overall good of humanity and so when I encountered the fellowship application while enrolled in the Clinical Research Management Program. Dr. Lechner has accompanied me through all my research activities with an interest to obtain data on best practices for increasing clinical research literacy in targeted populations.”

My studies have offered a window into the importance of community-based partnership when conducting research, and I believe that this fellowship opportunity would help me understand the intricacies of various community engagement best practices that I can use as a researcher.”

Experiences as a Fellow

Mathurin-Gervais’ day-to-day fellowship training and activities aligns with the general roles and responsibilities of a study coordinator at a clinical research site. She shares, “All of my experiences fall into three notable categories (1) Advanced Clinical Research Management Research Professional Development and Training developed by the ACRP (Association for Clinical Research Professionals) (2) Assignment to the Merck IMPOWER 022 study at the Rutgers New Jersey Medical School Clinical Research Center Research with a Heart and (3) Preparing a Manuscript for Publication in a Peer-Reviewed Journal.

Most Impactful Experience

The work with the Merck IMPOWER 022 study is what inspired Alene the most. Mathurin details, “It is a Phase 3, randomized, active-controlled, doubled-blind clinical study to evaluate the efficacy and safety of oral islatravir once-monthly, as preexposure prophylaxis in cisgender women at high risk for HIV-1 infection. The trial compares the efficacy and safety of islatravir to Truvada which is an antiretroviral FDA-approved drug used as a PrEP in high-risk HIV-1 individuals.”  Her newfound knowledge is helping to increase awareness of PrEP drugs in minority communities, giving the opportunity to give members the tools they need to make health decisions that are in own interests.

Final Projects

Mathurin-Gervais’ final close-out projects include (1) preparing a manuscript for publication, (2) giving a poster presentation at the NJ ACTS Intern and Fellowship Symposium, and (3) crafting a summary of her fellowship experiences while working on the IMPOWER 022 study.

The Future

When asked about her future after participating in the NJ ACTS CRM Fellowship, Mathurin-Gervais responded, “I say this humbly, my future is very bright! This fellowship opportunity has given me valuable and transferable experiences as a translational researcher. I am no longer threatened by the intricacies of writing a systematic research manuscript for publication. Dr. Lauren Aleksunes once said that some translational researchers are boundary crossers, capable of leaving their silos and navigating across new research territories. I look forward to chances to navigate across translational research areas as a team player, keeping in mind the importance of patient populations’ perspectives while striving to adapt these perspectives in all stages of research.”

Overall Impressionof the Fellowship

Mathurin says, “I am deeply honored to have been named a NJ ACTS/Rutgers School of Health Professions Fellow in Clinical Research Management. The incredible training opportunities and other experiences that have followed have been milestones in my career. I offer my sincere thanks to each of the professionals who oversee and implement this program—their dedication and diligence have been evident every step of the way. The members of the incredible team at the Workforce Development Core of NJ ACTS have been excellent resources who have created a myriad of innovative training opportunities. I must especially thank Yasheca Ebanks, NJ ACTS Project Manager, who seemed to have the answer to every question I asked—her professionalism made my time as a Fellow far easier.”

Advice to Future Fellows

“…Understand the sheer significance of this opportunity and your role in helping shape the outcome of your time as a fellow. Have intellectual humility—you’ll learn more and may even question things you thought you knew. (That’s what can happen when you employ the Socratic method!)

Your fellowship guidance is your bible, guiding you toward important deadlines and deliverables. Have fun along the way, and find creative ways of managing stress. The workload is intense, but it’s manageable.

Finally, you’ll come across some brilliant minds that may cause you to question your own brilliance. Remember that greatness lies within each of us and that collectively we can use what we have, through team efforts, to advance the field of translational science together.”

Meet Megha Master

Our Inaugural Clinical Research Management Fellow

 

Megha Master, Inaugural Clinical Research Management Fellow

Megha Master, MS completed a 6-month NJ ACTS Clinical Research Management Fellowship in the Robert Wood Johnson Clinical Research Center (CRC).  The Workforce Core recently spoke with Megha to learn more about her journey and career development. Click the topics below to find out what we learned:

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Previous experience
Megha received her Bachelors degree in Chemistry in India and then pursued a second degree in Biochemistry from Rutgers University on Cook Campus. After graduating, she worked in industrial quality management and eventually found herself with an opportunity to obtain a Master’s degree from the Rutgers Clinical Trials Sciences program with a specialty in Clinical Regulatory Affairs. During her post-graduate didactic training, Megha completed a Capstone Project  as an Institutional Review Board (IRB) intern on the Rutgers Health and Sciences IRB review board in Newark, NJ. She graduated in 2019.
Inspiration
Her Program Director, Dr. Doreen W Lechner, was a major advocate for Megha and inspired her to apply for the fellowship program after finishing the Master’s degree.
Experiences as a Fellow
During the fellowship, Megha has been assigned monthly activities and submitted biweekly summaries of her work to encourage feedback and collaboration. During the first 2 months, Megha shadowed an expert in each position at the CRC; this was a great way to learn about all the roles required for effective clinical research management. Megha was also assigned the task of generating  new clinical research Standard Operating Procedures (SOPs) of her choice and making revisions to an additional  SOPS that were up for review. Megha was also expected to follow two clinical studies by participating in the enrollment process, patient visits, follow up care, and observational evaluation.
Most impactful experience
The study that inspired Megha the most was observing the PROMISE study; an observational study designed to follow patients with cystic fibrosis before and during treatment with a new triple combination drug approved this past November. Megha described how incredible it was to see participants come in with debilitating symptoms of their illness ill for their enrollment appointment and to watch the positive change in their health over time. At the end of her experience with  this study, she presented the clinical research to trainees and faculty from the Clinical Research Management program. Megha also discussed the broad experience she has had throughout the fellowship and how greatly it has impacted her.
Final projects
Megha’s final task was to assume a leadership role on one of the projects that the CRC was in need of completing to improve day-to-day management. Megha was given a number of options and chose to tackle the development of a crisis communication plan; a plan designed to assist personnel in responding to inquires surrounding a major unanticipated event, especially in the involvement of media. This required Megha to collaborate and reach out to a number of offices and departments across Rutgers. Her ultimate goal, once the plan is approved, is to generate a very simple flow chart that can answer “what do I do?” in a moment of crisis. Original plans for Megha  to present this research had been derailed by the current COVID-19 pandemic and, in the meantime, she has taken to generating a tool for Rutgers project managers and employees that allows them to go through a number of questions in the event of a potential crisis and provide an action plan specific to that event.
The future
Megha will pursue work in regulatory components of clinical research in either industry or academia.
Overall impression of the Fellowship
Megha found the fellowship to be an amazing opportunity to collaborate and learn about the complete process of clinical research. Her time as a fellow allowed Megha to really understand and experience the process from the eyes of the patients and their families.
Advice to future Fellows
“… take full advantage of the vast range of experiences the program has to offer and always take the time to appreciate the perspective of the patient.”

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