Clinical Trialist Training Program

At the time of application, physicians must have, at a minimum, a partially-developed investigator-initiated clinical trial concept that can be ideally initiated within the two years of the program. Expectations include that the physician will lead the development of the design of the clinical trial and its execution as the principal investigator under the guidance of an established clinical trialist who will serve as a mentor for the duration of the program.  The anticipated source of funding for the trial needs to be articulated at the time of application. Budget development and negotiation is considered an integral part of both the development of a research project and its feasibility therefore participants should be included in these conversations, if possible, in advance of and during the CTTP.

The product or output of the program is a fully developed IRB approved trial that is enrolling by the end of year one. As a requirement of successful completion of the program, the participant will be expected to prepare a manuscript for submission or a presentation at a national meeting.

CTTP Participants pursue a customized career development plan. Pillars of the program are coursework tailored to the needs of the participant, IRB membership, and ad hoc mentorship.

Sample coursework available to participants include, but is not limited to:

• Principles of drug development
• Clinical trial design and protocol development
• Operational study management and clinical trial execution
• Regulatory principles
• Intro to Biostatistics

ITMAT Ed Faculty and Staff provide suggestions based on the specific needs of the participant. The option to advance to a more formal existing certificate or degree program are also available.

Participants are encouraged to attend the ITMAT Education Professional Skills Development Program (PSDSP). This program supports clinical and translational scientists to successfully execute research endeavors on the path to independence. Sessions are designed to advance the knowledge, skills, and attributes in key competency areas to enhance clinical investigators’ abilities to collaborate, lead, direct, network, manage up, navigate conflicts, negotiate, and more.

Participants will serve as an IRB member throughout the duration of the program and be mentored by the IRB Chair. This membership experience will expose participants to real issues, considerations, and solutions in human subject’s research and study design.

At the end of the 2-year program, participants are invited to present their research project experience, with a particular focus on hurdled encounters and how they overcame those barriers with successful strategies to past and present CTTP participants.

Effective mentoring requires the primary mentor dedicate substantial time to ensure personal and professional development of the mentee. We recognize the importance of strong mentoring attributes and the significant time required to mentor effectively, thus experienced clinical trialists will serve in this role. The Mentor-Mentee Compact will be available to all mentors and mentees to initiate discussion and clarify expectations and responsibilities of both parties.  A member of the ITMAT Ed faculty will be assigned to provide programmatic mentorship throughout the duration of the program.

• Applicants must have an MD degree
• Applicants must be a dedicated clinician and committed to a career path in developing and implementing investigator initiated clinical trials
• Preference is given to Instructors and Assistant Professors (within their first three years of appointment)
  • However, more advanced faculty considering a pivot in their career to clinical trials will be considered
• Faculty in the AC, CE, and Tenure Track are eligible to apply
  • Preferential consideration is given to faculty in the AC track

Applicants should not have concurrent sources of salary support for research time

Applicants to the Clinical Trialist Training Program may apply in tandem to the Clinical Trials Scholarship, which provides physicians up to 25% protected time to dedicate towards the program for 2 years. If applying for the scholarship, applicants should not have concurrent sources of salary support for research time.

The Clinical Trials Scholarship is part of the suite of ITMAT Ed Career Development Awards.

Application Requirements

Only one application is required for both the Clinical Trialist Training Program and Scholarship.

The application includes the following required items:

1. Application form which includes:

• Curriculum Vitae
• Personal Statement:
  • A one-page description of the applicant’s academic track, career goals, and how the program will support these goals
• Other Support (Funding Support for Applicant):
  • A description of how the applicant’s time will be protected, or a request to be considered for the Clinical Trials Scholarship (indicate percent effort being requested –maximum amount available is 25% effort based on NIH funding maximums). If applying for the scholarship, applicants should not have concurrent sources of salary support for research time.
• Research Statement: 2-3-page description of proposed trial or submit the IIT Protocol if it is available.

2. Letter of Support from Primary Mentor

• The mentor's letter of support should comment on the following:
  • Commitment to mentor the candidate
  • Suitability of the candidate for the program
  • Assessment of the value of the research project and its feasibility
  • Mentor’s prior experience mentoring clinical researchers
  • Candidate's access to clinical research support staff
  • Availability of funding for study execution
  • Presence of unresolved contractual obligations that need to be addressed

3. Letter of Support from Departmental Chair (Applicants should request their Department Chair email an attached letter of support to ITMAT Education at jbgerman@upenn.edu)

• Commitment of the division/department to the candidate’s research direction and career goals
• Guarantee of 25% protected time for the candidate to conduct clinical trials
• Availability of resources for the candidate

Applicants, please add headers with your name to the applicable documents.

To submit an online application, you will need to create a CollegeNet account and follow the steps below

1. Create a CollegeNet account. After logging into CollegeNet, select “Online Application”.
2. Enter your Personal Information.  Save and continue to Program Information. 
3. Choose “Perelman School of Medicine - Masters and Certificate Programs”
   • Search and select “ITMAT Clinical Trials Fellowship" (note that it will appear under this name, not "Clinical Trialist Training Program," due to a recent name change)
   • Select "Fall 2023" term.
4. You can enter information in stages, at your own pace, and access the application any number of times until submission.
5. You will enter the recommender information into the system which will send the letter request to your primary mentor.
6. Once the application has been fully submitted, you can return to your account to check the status of your application and letters from your recommender and department chair. The department chair letter will be uploaded into your application from a member of the ITMAT Education team.

ITMAT Education Faculty and Administration encourage interested applicants to contact us.  Jessica German and Dr. Marina Cuchel will reach out to set up a time to discuss your interest in the CTTP. Through this initial consult, program faculty and/or staff can gain understanding to how this program may best align with your career goals, connect interested applicants to current students or past participants, answer questions about the application process, provide feedback on project proposals or mentorship.

• I do not currently work at Penn. Am I eligible for the program and/or scholarship?
  • Clinical Trialist Training Program participants must be employed at Penn upon entering the program.
• What is the application timeline?
  • Applications are accepted on a rolling basis.
• Are all academic tracks able to apply for this program?
  • Tenure, CE, and AC track faculty are encouraged to apply.
• Are PhDs eligible for this program?
  • This program is geared toward physicians.
• Are more advanced faculty eligible to apply?
  • Advanced faculty considering a pivot in their career to clinical trials will be considered.
• Can I apply for this program if I am not seeking financial support?
  • We encourage you to apply. Please indicate your funding sources in your application and describe your interests in this program.
• Can I apply for this program if I am seeking partial or up to 25% protected time to conduct clinical trials?
  • We encourage you to apply. Please indicate your percent effort being requested and describe your interests in this program.
• What is the timeline from application to selection to start-date?
  • Start date would be a term later.

Learn more about the Previous Cohorts here.

• Coursework
  • ITMAT Education Courses
    • MTR/REG 5100 provides sessions on budgeting and negotiation. 
  • UPenn Course Catalog
  • Ethics and Trial Design
• Professional Development 
  • ITMAT Education Professional Skills Development Program (PSDP)

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