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Research Assistant II / 40 hours / Day / BWH- Men's Health

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Location
Boston, MA
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Job Description:

The Mens Health, Aging and Metabolism Clinical Research Unit at Brigham and Womens 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 unit Directors and Principal Investigators, the Research Assistant II (RAII) will participate in all aspects of the day to day management of one or more clinical research studies.

The RA IIs specific duties may include:

* Schedule and conduct study visits in the Mens 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.

* 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.

* Contribute 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.

* Perform additional tasks as assigned.

Skills:

* 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.

* Bachelors degree.

* Minimum of 2 years of progressively more responsible clinical 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).

* 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.

Skills:

* 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.

Company info

Brigham & Women's Hospital(BWH)

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