Clinical Research Coordinator 2

Department
 

BSD MED - Hospital Medicine - Clinical Research Staff - Hospitalist

About the Department
 

The Section of Hospital Medicine prides itself on its strong and integrated programs in clinical care, research, and education. The strength of our clinical programs is essential not only to our ability to provide excellent patient care, but to our ability to perform research that advances the frontiers of clinical practice and to train future generations of physicians in hospital medicine. Our research programs allow us to advance the scientific basis and clinical practice of hospital medicine and to train hospital medicine researchers who can carry this scientific mission into the future, often finding inspiration in the desire to solve clinical dilemmas we encounter in our own practices. Likewise, our training programs allow us to bring talented young persons into the relatively new field of hospital medicine, preparing them for productive and sustainable careers as clinicians, researchers, and educators.

Job Summary
 

The Clinical Research Coordinator II (CRC2) is a specialized researcher working with the Principal Investigator (PI) Dr. David Meltzer, Co-Investigator(s) and other study personnel, and under the limited direction of departmental, clinical research director/manager and/or the Office of Clinical Research (OCR). With limited supervision and/or guidance, the CRC2 works with the PI, Co-Investigator(s), department, sponsoring agencies, and/or the OCR to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study. The CRC2 will work primarily on the Hospitalist Project, a survey research infrastructure which collects longitudinal data from hospitalized patients during their inpatient stay and post-discharge about their health, background, and social lives to help inform broad research and quality improvement questions about improving care for hospitalized patients.

Responsibilities

• Support data collection operations through recruitment, onboarding, and day-to-day supervision of research personnel.

• Monitor training in data collection and informed consent protocols to ensure IRB compliance.

• 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.

• Participate in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

• Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.

• Ensure Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.

• Maintain 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.

• Organize and attends site visits from sponsors and other relevant study meetings.

• Understand the federal research regulations and identify the federal research organizations’ role in regulating human research participation.

• Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

• Analyzes 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 Qualifications
 

Education:

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

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Work Experience:

Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

• Bachelor's degree.

Experience:

• Knowledge of medical terminology/environment.

Preferred Competencies

• Ability to interact