BSD MED – Section Administrator: Hospital Medicine – CCP Clinical Research Staff
About the Department
The Clinical Research Coordinator 1 will be a member of the research team in Hospital Medicine, working on projects for the Comprehensive Care Program (CCP). CCP research includes several randomized trials that study the impact of having the same physicians care for patients at increased risk of hospitalization in both the inpatient and outpatient settings as well as understand and address unmet social needs. The Clinical Research Coordinator 1 will provide support to the research faculty in the Section of Hospital Medicine and within the Department of Medicine.
The Clinical Research Coordinator 1 (CRC1) is an entry level researcher working with the Principal Investigator (PI) Dr. David Meltzer, Co-Investigator(s) and other study personnel, and under the limited direction of departmental, Research Director. The CRC1 works with the PI, Co-Investigator(s), department, sponsoring agencies, and/or the to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study.
- Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
- Organizes and attends site visits from sponsors and other relevant study meetings.
- Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
- Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
- Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF’s), drug dispensing logs, and study related communication.
- Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions.
- Understand the federal research regulations and identify the federal research organizations’ role in regulating human research participation.
- Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
- Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
- Performs other related work as needed.
Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).—
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
- Bachelors degree.
- One year of research experience or relevant experience.
- Knowledge of medical terminology/environment.
- Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
- Ability to communicate with tact and diplomacy.
- Strong organizational skills.
- Strong communication skills (verbal and written).
- Excellent interpersonal skills.
- Strong data management skills and attention to detail.
- Knowledge of Microsoft Word, Excel and Adobe Acrobat.
- Ability to read and understand complex documents (e.g., clinical trials).
- Ability to handle competing demands with diplomacy and enthusiasm.
- Ability to absorb large amounts of information quickly.
- Adaptability to changing working situations and work assignments.