Clinical Research Coordinator 1

Department

BSD MED - Hospital Medicine - Clinical Research Staff - CCP

About the Department

Hospital Medicine is a rapidly growing field within internal medicine where physicians, called ‘Hospitalists’, focus their practice on the care of hospitalized patients. Although clinical needs have been the driving force behind the growth of Hospital Medicine nationally, our program has always had a major academic focus on research, quality improvement, and teaching. The Comprehensive Care Physician (CCP) Program is an innovative program within the Section of Hospital Medicine that provides patients with complex medical and social needs a physician who cares for them in both, the hospital and the clinic.

The CCP model has been studied in a randomized trial since 2012 with funding from the Center for Medicare and Medicaid Innovation (CMMI) and has shown statistically significant improvements in patient experience and health outcomes and decreases in hospitalization and spending. In addition, this model and study have evolved to since better engage patients and address social determinants of health. Since 2016, first with funding from the Robert Wood Johnson Foundation and now from the Patient-Centered Outcomes Research Institute (PCORI), we have created the Comprehensive Care Community and Culture Program (C4P), which adds to CCP: 1) systematic screening of unmet social needs, 2) access to a community health worker, and 3) access to community-based arts and culture programming. C4P is also being evaluated through a randomized trial and has produced promising preliminary findings, particularly in activating patients.

Job Summary

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, and/or sponsoring agencies, to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study.

Responsibilities

• Coordinates 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.

• Develop, implement, and maintain high-quality training protocols and materials for research staff, including comprehensive onboarding  processes, continuing education opportunities, and skills assessments to ensure compliance with regulatory requirements and study protocols.

• Provides administrative support to the research team as needed, including managing calendars and facilitating meetings.

• Serves as a resource and supervisor by providing day-to-day oversight and guidance to Research Assistants.

• Organizes and attends site visits from sponsors and other relevant study meetings

• Protects 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 consents, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.

• Understands 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.

• Understands the federal research regulations and identifies the federal research organizations’ role in regulating human research participation.

• Prepares for or participates 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.

• Accountable for all tasks in basic clinical studies.

• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.

• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed thr