Senior Research Assistant, 40 Hours, Preventive Medicine
Brigham & Women's Hospital(BWH)

GENERAL SUMMARY:

Works under very general direction of the Project Manager and Principal Investigator to gather data on observational research studies involving the identification of novel risk factors for coronary heart disease and sudden cardiac death among men and women. The research is being performed in large-scale cohorts within the Division of Preventive Medicine at Brigham & Women's Hospital including the PRE-DETERMINE Study and VITAL Trial.

Responsible for executing procedures, managing staff, monitoring progress, and contributing to policy decisions made for the studies. Oversee day to day activities of endpoint coordination (data collection and processing) from beginning to end to gather valuable study data among the PRE-DETERMINE Study, as well as 5 other large-scale cohorts. These processes include contacting participants and family members by mail and phone to collect essential questionnaires, consent forms, medical records, death certificates, autopsy reports, and other documents necessary to validate study endpoints. Review participant's records prior to endpoint adjudication for completeness and manage databases used to track participant, endpoint, state and site follow-up. The ideal applicant will be very comfortable using Microsoft Word, Excel and Access, have prior supervisory/data management experience, and an intermediate understanding of medical terminology.

Other responsibilities include: leading operational staff meetings, reviewing applications to state vital statistics offices, preparing Institutional Review Board (IRB) submissions for internal reviews, as well as for clinical sites.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Manages and coordinates the assignment of research assistant activities on multiple studies to ensure compliance with study protocol and HIPAA guidelines. Leads operational staff meetings, as well as bi-weekly one on one meetings. Creates and maintains operational manuals to reflect current research activities and workflows.

Makes recommendations for improving current and new data collection systems for data integrity and timeliness, as well as presents study progress reports to the Project Manager and Principal Investigator. Works directly with study programmer(s) regarding data cleaning/processing, as well as develops and tests data collection forms in Teleform Designer and/or Transperfect.

Conducts Research Assistant activities as needed to monitor efficiency and meet deadlines. Responsibilities include: contact participants and family members by mail and phone to collect essential questionnaires, consent forms, medical records, death certificates, autopsy reports, and other documents necessary to validate study endpoints. Update endpoint databases and tracking systems, as well as process data forms.

Conducts preliminary review of participant files prepared for review by the study investigators, as well as oversees data management issues and develops solutions.

Reviews all submissions to state vital statistics departments for death certificate application. Provides feedback to Research Assistants, works closely with Research Management to finalize data use agreements, maintains state application protocols, and tracks the application process.

Responsible for interviewing, training and supervising staff to ensure full compliance and knowledge of assigned project(s). Specific duties include: hiring, disciplining, managing, evaluating, time keeping and communicating when necessary with the Project Manager and the Principal Investigator.

Aides in all aspects of PRE-DETERMINE clinical site activities (Institutional Review Board (IRB) reviews, name/staff changes, closures, etc.), by responding to study related inquires via phone and email.

Prepares documents for submission to the Institutional Review Board and Data Safety Monitoring Board to ensure continuing approvals. Assists with grant and manuscript submissions when needed.

Responsible for the oversight for all study material, supplies, equipment, and storage.

Performs all other duties as assigned.

Qualifications
QUALIFICATIONS:

College degree.

High degree of computer literacy, especially MS Office Suite.

Strong knowledge of word-processing and operating computer software programs, such as Microsoft Word, Excel and Access.

Knowledge of medical terminology.

Prior supervisory experience preferred.

Familiarity with ICD coding and classification schemes considered a plus.

Minimum of 3-5 years of work experience in a research setting.

Sound independent judgment and competence in research methodologies.

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

Ability to supervise and train staff effectively.

Ability to work well in a team, as well as independently.

Ability to organize and prioritize multiple tasks, and set deadlines.

Excellent interpersonal, oral, and written communication skills.

Ability to identify problems and develop solutions.

Attention to detail.

Knowledge of clinical research protocols.

Ability to demonstrate professionalism and respect for subject's rights and individual needs.

EEO Statement
BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

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