Research Assistant I DOM Men's Health

GENERAL SUMMARY/ OVERVIEW STATEMENT: Summarize the nature and level of work performed.

The Men's Health, Aging and Metabolism Clinical Research Unit at Brigham and Women's Hospital conducts government and industry sponsored clinical trials, covering a wide range of therapeutic areas, with study populations that include both women and men.

Under the supervision Principal Investigators and Recruitment Project Manager, the Clinical Research Coordinator will provide support to Senior Research Coordinators and participate in all aspects of the day to day management of one or more clinical research studies.

PRINCIPAL DUTIES AND RESPONSIBILITIES: Indicate key areas of responsibility, major job duties, special projects and key objectives for this position. These items should be evaluated throughout the year and included in the written annual evaluation.

The RA I/ Clinical Research Coordinator's specific duties may include:

• Help to implementation of clinical trial recruitment strategies and social media postings.

• Assist in the Prepare summary reports for project team regarding enrollment status and study progress.

• Schedule study visits in the Men's Health Clinical Research unit. Coordinate study procedures to be conducted outside the unit at the Laboratory of Exercise Physiology and Physical Performance and at other institutional research locations.

• Review electronic medical records to pre-screen patients for study eligibility.

• Perform medical record abstraction for study relevant data.

• Assist with preparation of IRB submissions (initial submissions, continuing reviews, amendments, exceptions, etc.).

• Contribute to the development of study specific documents, e.g., case report forms (CRFs), eligibility screening scripts and questionnaires, informed consent forms, protocol summaries, and subject recruitment materials.

• Perform data entry on an ongoing basis.

• Screen subjects over the telephone to determine their initial eligibility for study participation

• Provide coverage for other study coordinators as needed.

• Perform additional tasks as assigned

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: (MUST be realistic, neither overstated nor understated, and related to the essential functions of the job.)

• Excellent organizational skills and an ability to effectively manage 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.

• 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.

QUALIFICATIONS: (MUST be realistic, neither overstated nor understated, and related to the essential functions of the job.)

• Bachelor's degree.

• Minimum of 1 year of research experience, preferably in a position that required a high degree of direct interaction with research subjects.

• Proficiency in Microsoft Office applications (Outlook, Word, Excel and PowerPoint).

• Familiarity with electronic data capture (EDC) systems preferred (e.g., REDCap and StudyTrax).

• Knowledge of medical terminology preferred.

• Certifications in the Protection of Human Subjects and Good Clinical Practice (or willingness to become certified), per institutional and regulatory guidelines.