What are the responsibilities and job description for the Clinical Research Associate-Regulatory position at Eisenhower Medical Center?
- Job Objective: A brief overview of the position.
- Research Administration at Eisenhower Health administers clinical trials on behalf of its investigators, including trials sponsored by National Cancer Institute cooperative groups, Division of AIDS, pharmaceutical companies, and physician investigators. Reporting directly to the Director of Research Administration, the Clinical Research Associate for Regulatory is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators within the Health System. Key to this role is the preparation and maintenance of clinical trial protocols and related regulatory documents for submission to the Eisenhower Human Research Protections Program (Eisenhower Medical Center's Institutional Review Board or IRB) in order to obtain its approval for the clinical trials to proceed. The Regulatory Research Associate will act as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical trials, including those of the FDA, OHRP, HHS, Eisenhower IRB, and the Research department. This position requires regular interaction with a variety of internal and external contacts including investigators and staff, EMC IRB staff, study sponsors and/or their representatives. Specialties actively engaged in clinical research include Oncology, HIV, Infectious Disease, Gastroenterology, Cardiology, Orthopedics and Pulmonology.
- Reports to
- Director, Research Administration
- Supervises
- None
- Ages of Patients
- Adult
- Geriatric
- Blood Borne Pathogens
- Minimal/No Potential
- Qualifications
- Education
- Required: Bachelors degree in healthcare and/or related field.
- Preferred: Masters degree
- Licensure/Certification
- Required: Completion of CITIProgram.org Good Clinical Practice (GCP) Course and Human Subjects Research (HSR) course within first 30 days of employment
- Preferred: www.ACRPnet.org CCRC or www.SOCRA.org CCRP Certification. Certification required upon eligibility.
- Experience
- Required: 2 years of experience with clinical trials, or related regulatory experience.
- Preferred: N/A
- Education
- Essential Responsibilities
- Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations.
- Perform pre-investigation, initiation & routine monitoring to assure that the protocol, obligations, responsibilities, and regulations are established & followed.
- Monitor subject records for quality, data integrity, & compliance with regulations and organization's SOPs.
- Prepare materials for Institutional Review Board (IRB) presentation; serve as a resource for the PI.
- Responsibilities related to regulatory coordination activities include independently managing and preparing submissions of new studies, modifications, renewals, adverse events, and study closures to the Institutional Review Board (IRB), Food and Drug Administration (FDA) and sponsors.
- Responsible for effectively shepherding protocols through the regulatory committee process in a timely manner to ensure activation of trial and for all regulatory aspects of the protocols assigned.
- Serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to sponsors, including the National Clinical Trials Network (NCTN) groups, pharmaceutical companies, and other research entities as needed.
- Create training documents and document staff training based on updates to research protocols.
- Distribute new protocol information to study team members.
- Update model informed consent document from sponsor with local context (boilerplate) language.
- Responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.
- Must accurately maintain standard regulatory files (electronic and hard copy), including:
- Monitoring Log
- Protocol and Amendments
- Standard Operating Procedures (SOPs) to ensure consistent handling and processing among the study team members.
- Manual of Operations (MOO) or Manual of Operations and Procedures (MOOP/MOP):
- Investigator Brochure/Drug Insert/Device Manual
- Source Documents & Case Report Forms
- Delegation of Authority / Site Signature Log
- Curriculum Vitae (CV) / Licensure
- Conflict Of Interest (COI)/Financial Disclosure
- 1571 / 1572 / IDE Documentation
- Training Documentation
- Screening / Enrollment Logs *
- Consent Forms
- Participant Materials / Correspondence
- Financial Accountability / Compensation Tracking
- Investigational Products Accountability
- IRB Submission and Approvals *
- DSMP / DSMB / DSMC reports
- Institutional Correspondence *
- Sponsor / Site / Other Correspondence
- Fluids / Samples Tracking
- Randomization / Blinding Plans
- Budgets and Contracts
- Lab Certifications
- Lab Reference Ranges / Normals
- Deviation Log *
- Deviation / Violation Reporting
- AE / SAE / UP Unanticipated Problem Reporting
- IND / IDE Safety & Other Reporting
- Notes to File
- Performs other duties as assigned.
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