- Coordinates development of clinical/scientific study protocols, informed consent forms (ICFs), manuals of procedure (MOPs), and standard operating procedures (SOPs) for domestic and international studies.
- Develops case report forms and other data collection tools and leads design and validation of electronic data capture (EDC) systems and databases (e.g., REDCap, CommCare).
- Leads development of data management plans and clinical quality management plans for studies, including plans for regular quality control/assurance (QA/QC) on study data/protocol implementation. Performs quality assurance/control (QA/QC) per DMPs and CQMPs for each protocol.
- 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].
- 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 regular domestic/international site monitoring visits to meet with stakeholders and perform audits on study protocol adherence/ 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 with investigators and statisticians in creating databases/datasets for analyses and performs descriptive analyses using statistical package (e.g., R, SAS).
- Supports Administrative Manager in budget tracking and projections and contracts management, including subawards, material transfer, and data use agreements (MTA/DUAs).
- 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.
- Spends ~10-20% time at international study sites (e.g., Western Cape, South Africa)
- Bachelors' degree required, preferably in Public Health. MS/MPH strongly preferred.
- Must have minimum of two (2) years experience with statistical analysis software (SAS) or equivalent program, understanding of data management in clinical research and experience with clinical/epidemiologic research, especially in international health/infectious diseases.
- 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, R, or equivalent is required. Excellent proficiency with Microsoft Office applications preferred.
- Working knowledge of electronic data capture systems, specifically, REDCap.
- Ability to learn and assimilate other related computer applications into data management practices.
- Demonstrated progressive work experience in project management and project planning.
- Competitive pay
- Tuition reimbursement and tuition remission programs
- Highly subsidized medical, dental, and vision insurance options
- Career Advancement/
- Pioneering Research: Engage in groundbreaking research projects that are driving the forefront of biomedical science.
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Research Study Coordinator, Infectious Diseases - Boston, United States - Boston Medical Center
Description
Position:
Research Study Coordinator, Infectious Diseases
Location:
Boston, MA
Schedule: 40 hours per week, Hybrid (On-site 2-3 days 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 at both domestic (Boston) and international (South Africa) sites.
Responsible for development and oversight of study documentation (i.e., protocols, data management and clinical quality management plans, standard operating procedures, informed consent forms, logs, etc.) and maintaining ethics compliance.
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
JOB REQUIREMENTS
EDUCATION:
EXPERIENCE:
KNOWLEDGE AND SKILLS:
JOB BENEFITS:
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.
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.
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 or call to let us know the nature of your request.
Equal Opportunity Employer/Disabled/Veterans
