Sr. Clinical Research Manager / 40 Hours / Day / BWH Radiation Oncology

Partners Healthcare System Boston , MA 02298

Posted 4 weeks ago

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The main objective of this position is to oversee the conduct and foster the growth of clinical research within the Radiation Oncology Department. This involves promoting standards for doing research, developing an environment that encourages clinical research, working with senior and junior physicians at every step in the process of developing a research project, and ensuring that adequate resources are available. It also entails acting as a liaison between the Radiation Oncology Department and the greater DF/HCC research community, managing a staff and joint budgetary planning and oversight.

PRINCIPAL DUTIES AND RESPONSIBILITIES:
1.Facilitate new and ongoing research projects and clinical trials in the department in terms of grant submission, protocol submission, trial coordination, data handling and analysis and regulatory compliance
2.Direct responsibility for the hiring, training, allocation, supervision and evaluation of research assistants (current n = 12)
3.Responsible for ensuring compliance with the federal and IRB/OHRS regulatory systems by LROC investigators (29 Boston-based faculty members, 28 residents and selected physics researchers). This includes rules for protocol submission, maintenance of regulatory files and management of research data. Keep track of the conduct of >100 open protocols including >20 prospective clinical trials. This includes overall responsibility for managing frequent routine internal and external monitoring and auditing reviews and insuring that they come to a satisfactory conclusion.
4.Responsible for integrating clinical research at the Milford, Mansfield and South Shore Hospital Radiation Oncology satellite sites into the Boston-based system. Ensure compliance with the DF/HCC IRB/OHRS systems by satellite investigators. Second-line oversight of the Satellite Research Project Manager.
5.Facilitate at all levels the preparation of protocols, grant submissions and manuscripts, including study design, protocol writing, finding and organizing data, liaison with the biostatisticians and editing of manuscripts for content and form. There is particular emphasis on teaching residents and junior attending physicians the principles of sound research practices. This also includes setting policies for database construction and access and overseeing a move toward use of the REDCap database system. Second-line oversight of the LROC Research Analyst.
6.One of 3 people jointly responsible for managing the budget for the Radiation Oncology Clinical Research section (>$900K/yr)
7.Organize several grant processes open to Radiation Oncology faculty (JCRT grants, Kaye grants, DM grants)
8.With the Radiation Oncology Research Trainee Program Chair, ensure that research trainees in the Department are appropriately onboarded and trained, have adequate resources and adhere to research and traineeship guidelines
9.Primary Radiation Oncology liaison with national cooperative groups sponsoring radiation oncology research and their administrative arms (NRG, CTSU, etc.)
10. Member of the LROC Clinical Research Resource Committee and responsible for organizing monthly meetings, setting the agenda and compiling the source material
11. Principal Radiation Oncology liaison with the DF/HCC Biostatistics Core
12. Member of the DF/HCC Clinical Research Operations Committee and primary Radiation Oncology liaison to other DF/HCC research entities, including the CTO, OHRS, ODQ and NCTN and the Senior VP for Research
13. Member of the DF/HCC Clinical Trials Leadership group
14. Member of the Radiation Oncology New Technology Committee
15. Disseminate and interpret HIPAA regulations and related hospital policy as they relate to clinical research
16. Consult on issues related to the legacy JCRT databases
17. Special projects at the request of the department chair (example: compiling and editing the department's 5-year HMS reviews)
18. Participate in grants and budgeting and discussions on contracting for clinical trials
19. Participate in disease specific research meetings as necessary

QUALIFICATIONS:
1.Bachelor's degree
2.Preferably 5-10 years experience in hands-on clinical research with progressively greater managerial responsibility

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
1.Detailed knowledge of federal and institutional regulatory requirements for human subject research
2.Proficiency in basic computer functions and knowledge of specialized computer applications, such as database software, statistical programs, etc.
3.Ability to handle multiple projects efficiently
4.Excellent managerial and organizational skills
5.Ability to work with many senior investigators and sensitively manage their priorities
6.Familiarity with grants, budgeting, and contracting is helpful

WORKING CONDITIONS:

Administrative office. Most work is done via computer with frequent meetings/consultations with investigators, research staff, OHRS/ODQ, IS staff and biostatisticians.

SUPERVISORY RESPONSIBILITY:

Direct supervision of 12 research coordinators and shared responsibility for 9 research trainees. Second-line supervision of the LROC Research Analyst and the Satellite Project Manager.

FISCAL RESPONSIBILITY:

One of 3 people jointly responsible for managing the budget for the Radiation Oncology Clinical Research section (>$900,000/yr). Responsible for ensuring that research staff salaries are set equitably.


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Sr. Clinical Research Manager / 40 Hours / Day / BWH Radiation Oncology

Partners Healthcare System