Clinical Trial Project Manager, Men's Health

Clinical Trial Project Manager, Men's Health-(3305343)

Description

GENERAL SUMMARY/ OVERVIEW STATEMENT:
Working within a dynamic clinical research setting and a newly funded Clinical Trials Recruitment Innovation Center at
Brigham and Women’s Hospital, the Clinical Trial Project Manager will oversee study recruitment and retention activities
for federal and industry sponsored clinical trials across a wide range of therapeutic areas and for trials involving both
women and men. (S) he will work closely with study PIs and other research team members to develop and implement
study-specific recruitment strategies to meet planned enrollment targets, including the recruitment of underrepresented
populations. The Clinical Trial Project Manager will maximize the utilization of existing recruitment methods and pioneer
new and innovative methods to enhance overall recruitment efforts and enrollment efficiency. (S) he will also lead
study retention efforts and implement behavioral strategies to maintain participant adherence to study interventions
and minimize overall loss to follow-up across trials. The Clinical Trial Project Manager will oversee the development of
recruitment and retention reports for study team review during regular team meetings and will contribute to manuscript
and grant proposal development. (S) he will also supervise the activities of the other members of the Recruitment
Innovation Center staff, including research assistants, junior level study recruiters, and graduate student recruiters.

PRINCIPAL DUTIES AND RESPONSIBILITIES:
The specific duties of the Clinical Trial Project Manager may include:
· Develop and lead the implementation of clinical trial recruitment strategies and social media postings for single-site and
multi-site clinical trials.
· Prepare summary reports for project teams regarding enrollment status and study progress.
· Oversee the preparation of study-specific recruitment materials for IRB submissions
· Contribute to the development of study specific documents, e.g., case report forms (CRFs), eligibility screening scripts
and questionnaires, and subject recruitment materials.
· Identifying protocol challenges and opportunities for recruitment/retention
· Initiate discussions to promote effective use of the recruitment and retention tools available to the site/study
· Prompt site follow up on pre-identified participants / screen failed patients
· Construct and maintain study database as well as oversee data entry on an ongoing basis.
· Assure adherence to intended timelines and achievement of study goals.
· Develop and implement measures to improve efficiency in recruitment operations.
· Direct management responsibility for study personnel, including 2 senior research coordinators, 2 research assistants, up
to 5 undergraduate/graduate student assistants, student interns and per diem staff.
· All other duties as assigned.

Qualifications

· Master’s degree
· Minimum of 3-5 years of progressively more responsibility clinical research recruitment experience.
· Minimum of 3 years prior experience management responsibility of research staff required.
- Proven record of successful problem-solving and decision framing skills pertaining to clinical trial recruitment.
· Proficiency in Microsoft Office applications (e.g. Outlook, Word, and Excel).
· Familiarity with electronic data capture (EDC) systems preferred (e.g. REDCap).
· Intermediate knowledge of medical terminology preferred.
· Certifications in the Protection of Human Subjects and Good Clinical Practice, per institutional and regulatory guidelines.

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
· Excellent organizational skills and an ability to effectively manage research personnel, time and prioritize workload.
· Strong oral and written communication skills.
· Excellent critical thinking and problem-solving skills.
· Analytical skills necessary to accurately interpret and implement complex policy.
· Comfortable working both independently and as part of team.
· Excellent interpersonal and relationships skills. Ability to build rapport and interact effectively with a broad array of people
from diverse cultural and educational backgrounds.
· High degree of professionalism, discretion, and confidentiality.
· Ability to supervise and train staff effectively.
· Strong database management, analytical and computer skills.