Senior Clinical Research Coordinator

3 weeks ago

Boston, United States Brigham and Women's Hospital Full time

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 of Principal Investigators, Directors and Team Lead, the Senior Research Assistant will be responsible for the coordination of clinical research trial(s) related to Aging and Metabolism. The RA II will be the main clinical trial liaison for the investigative research team, the research subjects, and the Sponsor. This highly motivated individual will have excellent interpersonal skills and the ability to multitask, conduct technical and administrative aspects of the research study including: coordination of staff and participants; lead study recruitment activities, coordinate study assessments and intervention activities, safety reporting, management of data and study documentation for Institutional Review Board (IRB), clinical research forms, and quality assurance. Some studies have exercise components, so an interest or familarity with exercise science is preferred.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The Senior RA's specific duties may include:

* Supervise other study research assistant staff who are involved in the intervention delivery and/or outcome assessment
* Manage communication, reports and tracking of deliverables for the research funders across both projects
* Manage the development of case record forms and study databases, in collaboration with biostatistics team and study investigators
* Coordinate and lead study team meetings, both with internal study team and with external investigators, collaborators and funders
* Schedule and conduct study visits in the 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.
* Administer consent to study subjects following Good Clinical Practice (GCP) guidelines.
* Participate in the development and implementation of subject recruitment strategies.
* Monitor and report the occurrence of adverse events as dictated by the guidelines of the sponsor and Partners Institutional Review Board (IRB).
* Prepare for and facilitate monitoring visits and quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Assist in developing corrective action plans when required. Respond to queries, if any, in a timely manner.
* Review electronic medical records to pre-screen patients for study eligibility.
* Perform medical record abstraction for study relevant data.
* Prepare summary reports for project team regarding enrollment status and study progress.
* Prepare 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.
* Maintain study regulatory documents and ensure study compliance with all government, sponsor, and IRB requirements.
* Contribution to the preparation of posters, abstracts, and manuscripts for publication.
* Maintain study database and perform data entry on an ongoing basis.
* Assure adherence to intended timelines and achievement of study goals.
* Develop and implement measures to improve efficiency in office operations.
* Provide coverage for other study coordinators as needed.

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

* 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.
* 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.
* Bachelor's degree (Master's degree preferred)
* Minimum of 3 years of progressively more responsible clinical research experience, preferably with research studies involving behavioral interventions/assessments of human performance that required a high degree of direct interaction with research subjects
* A background in exercise piahysiology or clinical research (or related field) is preferred but not required.
* Proficiency in Microsoft Office applications (Outlook, Word, Excel and PowerPoint).
* Familiarity with electronic data capture (EDC) systems preferred (e.g., REDCap and StudyTrax).
* Intermediate 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.

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