Research Study Coordinator, Infectious Diseases

Position: Research Study Coordinator, infectious Diseases

Location: Boston, MA

Schedule: 40 hours per week, Hybrid (4 days on-site/1 day remote per week)

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 Study Coordinator is responsible for on- and off-site study implementation and data management of clinical research studies on tuberculosis (TB) at both domestic (Boston) and international (South Africa) sites. The Study Coordinator will be responsible for development and oversight of study documentation and maintaining ethics compliance. Interested candidates should have strong data analysis and computing programming skills and be able to manipulate, transform, analyze and summarize large data sets. The Study Coordinator will work directly with study field teams to meet project milestones and support investigators in dissemination of findings.

JOB RESPONSIBILITIES:

Protocol and study document development

• Supports development of clinical/scientific study protocols, informed consent forms (ICFs), manuals of procedure (MOPs), and standard operating procedures (SOPs) for domestic and international studies.
• Supports development of data management plans (DMPs) and clinical quality management plans (CQMPs) for studies, including plans for regular quality control/assurance (QA/QC) on study data and protocol implementation.
• Performs quality assurance/control (QA/QC) per DMPs and CQMPs for each protocol.  Coordinate QA/QC with on-site staff and investigators.  
• Develops training materials on study protocols, research and clinical SOPs, and data collection procedures and supports training of study teams [e.g., research assistants (RAs), research nurses, field workers].  

​Data Management and Analysis

• Data manipulation, including cleaning, transformation, and summary
• Develops case report forms (CRFs) and other data collection tools and leads design and validation of electronic data capture (EDC) systems and databases (e.g., REDCap).
• Development, execution and management of QA/QC plans and R code. 
• Maintains EDCs and data dictionaries. Ensures data integrity and protocol adherence by conducting routine on-site and remote QA/QC procedures per DMPs and CQMPs.
• Works with investigators and statisticians in creating databases/datasets for analyses and performs descriptive analyses using statistical package (e.g., R).

Study Implementation

• Maintains ethics and regulatory compliance, including initial international and domestic institutional review board (IRB) and ethics committee (ECs) submissions, amendments, reportable events, and annual reporting. Maintains regulatory binders and study master files. 
• Oversees the launch of new domestic and international studies. Ensures protocol adherence and smooth study implementation for ongoing studies. Serves as the conduit between various study sites, including laboratory partners. 
• Conducts domestic and international site monitoring visits to meet with stakeholders and perform audits on study protocol adherence and implementation. 
• Reports to investigators on study progress and protocol milestones. Generates routine progress reports and aids in preparing annual reports to donors and ethics.
• Works closely with Manager to navigate deviations from protocol, displays forethought in identifying potential crises and devises appropriate contingency plans

Other duties

• Aids in preparation of abstracts, posters, and manuscripts for scientific meetings and journals.
• Schedules and leads regular study team meetings, sets agendas, and records minutes for distribution. Prioritizes work to ensure appropriate and timely preparation for meetings and meets deliverable deadlines.
• Performs other duties as needed or as assigned to ensure smooth operations and responsiveness of projects and team.
• Spends ~5-10% time at international study sites (e.g., Western Cape, South Africa)

(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 R statistical computing software, 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 subject’s 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 R statistical computing software is required. Excellent proficiency with Microsoft Office applications is required.
• Adept at communicating questions and proactively communicating concerns
• Working knowledge of electronic data capture systems, specifically, REDCap.
• Demonstrated progressive work experience in project management and project planning.
• Excellent oral and written communication skills and interpersonal skills

This position is grant funded through 5/31/26. There may be opportunity beyond this grant funding for position integration into ongoing operations.

JOB BENEFITS:

• Competitive pay
• Tuition reimbursement and tuition remission programs
• Highly subsidized medical, dental, and vision insurance options
• Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research.
• Pioneering Research: Engage in groundbreaking research projects that are driving the forefront of biomedical science.

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 Talentacquisition@bmc.org or call 617-638-8582 to let us know the nature of your request.

Equal Opportunity Employer/Disabled/Veterans