Research Study Coordinator - ERPO Clinician Petitioner Education and Implementation

Position: Research Study Coordinator , Trauma Surgery

Location: Boston, MA

Schedule: Per Diem, Hybrid

ABOUT BMC:

At Boston Medical Center (BMC), our diverse staff works together for one goal — to provide exceptional and equitable care to improve the health of the people of Boston. Our bold vision to transform health care is powered by our respect for our patients and our commitment to ensure everyone who comes through our doors has a positive experience.

You’ll find a supportive work environment at BMC, with rich opportunities throughout your career for training, development, and growth and where you’ll have the tools you need to take charge of your own practice environment.  

POSITION SUMMARY:

The Research Study Coordinator is responsible for off-site study coordination and data management oversight.  The Study Coordinator will provide study coordination of specific protocols – including implementing and monitoring quality control SOPs; conducting period quality assurance monitoring; and working with investigators at BMC.  The Study Coordinator will work with investigators to develop case report forms consistent with clinical protocols, sets up SOPs for clinical conduct, data collection, assist site staff/investigators in study implementation and performs quality assurance audits to validate data in preparation for analysis by biostatisticians

JOB RESPONSIBILITIES

• Coordinates the initiation of research study protocol, and the establishment of operating policies and procedures. Plans, implements, and maintains data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data.
• Coordinates research subjects as appropriate to specific study objectives and work scope.
• Ensures the smooth and efficient day-to-day operation of research and data collection activities; acts as the primary administrative point of contact for research subjects and principal investigators. 
• Coordinates the day-to-day activities of any technical support staff specifically engaged in the carrying out of research protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives.

• Supervises and coordinates the provision of support services to investigators and researchers.
• Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
• Implements quality control process throughout the conduct of the trial
• Participates in clinical floor activities on an ongoing basis with research staff to ensure adequate clinical support for trial activities.

(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job.  The above is not intended to represent an exhaustive list of accountable duties and responsibilities required).

JOB REQUIREMENTS

EDUCATION:

• Bachelors' degree required, preferably in Public Health. 

• MS/MPH strongly preferred.

EXPERIENCE:

• Must have minimum of two (2) years experience with statistical analysis software (SAS), understanding of data management in clinical research and experience with clinical/epidemiologic research, especially in international health/infectious diseases.

KNOWLEDGE AND SKILLS:

• Understanding of clinical research components – data collection issues, human subjects protection, quality assurance and control.

• Familiarity with ICH Good Clinical Practices (GCP) consistent with registration clinical trials (FDA Guidance for Industry for Computerized Systems used in Clinical Trials (Title 21 CFR Part 11) preferred.

• Excellent programming ability in SAS statistical software is required.  Knowledge of other programming and other scripting language is advantageous.

• Intermediate proficiency with Microsoft Office applications, use of file transfer protocols (FTP) preferred. Ability to learn/assimilate other related computer applications into data management practices. Proficiency in a high level programming language preferred.

• Working knowledge of electronic data capture systems, specifically, Teleform (Autonomy Cardiff, Vista, CA) software preferred.

• Demonstrated progressive work experience in project management and project planning. Excellent interpersonal as well as oral and written communication skills.

• Excellent organizational skills, including ability to multi-task, set priorities and meet timetables while managing several simultaneous projects.

ABOUT THE DEPARTMENT:

As the primary teaching hospital for Boston University Chobanian & Avedisian School of Medicine and BU schools of public health and dentistry, intellectual rigor shapes our inquiries. Our research is led by a belief that skin color, zip code, and financial circumstances shouldn’t dictate health.

Boston Medical Center is an Equal Opportunity/Affirmative Action Employer. If you need accommodation for any part of the application process because of a medical condition or disability, please send an e-mail to [email protected] or call 617-638-8582 to let us know the nature of your request.

Equal Opportunity Employer/Disabled/Veterans