Clinical Research Associate-Regulatory

Default Work Shift:

Varies (United States of America)

Hours:

24

Salary range:

$22.83 - $34.51

Schedule:

Part Time

Shift Hours:

8 Hour employee

Department:

Research-Oncology

Job Objective:

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. Acts as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies and procedures concerning the conduct of clinical trials, including those of the FDA, OHRP, HHS, Eisenhower IRB, and the Research department.

Job Description:

Education:
Required: Bachelor’s degree in healthcare and/or related field; completion of CITIProgram.org Good Clinical Practice (GCP) Course and Human Subjects Research (HSR) course within thirty (30) days of hire
Preferred: Master’s degree

Licensure/Certification:
Required: Certification from Society of Clinical Research Associate (SOCRA) as a Certified Clinical Research Professional (CCRP) or Certification from Association of Clinical Research Professionals (ACRP), such as, Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), ACRP Certified Professional (ACRP-CP) within twelve (12) months of eligibility (as determined by SOCRA or ACRP certification requirements)

Experience:
Required: Two (2) years of experience with clinical trials or related regulatory experience
Preferred: Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research; experience developing and maintaining record management systems; experience preparing various forms, documents and reports

Reports To: Director-Research Administration Supervises: N/A Ages of Patients: Adult, Geriatric Blood Borne Pathogens: Minimal/ No Potential

Skills, Knowledge, Abilities:

Ability to collaborate with clinicians and stakeholders to make timely, informed decisions that support patient care and research objectives, Ability to communicate clinical research information clearly, accurately, and professionally to patients, physicians, sponsors, and multidisciplinary research teams, Ability to demonstrate professionalism by acting with integrity, accountability, responsibility, and excellence while maintaining a professional appearance and fostering effective communication and collaboration, Ability to effectively manage multiple priorities, timelines, and competing responsibilities while demonstrating leadership, critical thinking, diplomacy, conflict resolution, and negotiation skills, Ability to identify challenges, analyze issues, and develop practical solutions while maintaining compliance with research protocols and patient safety requirements, Ability to maintain a high level of accuracy, recognize discrepancies, and identify potential issues before they impact study quality or operations, Ability to review, interpret, analyze, and communicate qualitative and quantitative data accurately and effectively, Ability to take ownership of assigned work, maintain accountability for outcomes, and contribute to a culture of trust, collaboration, and shared success, Ability to work independently, demonstrate initiative, and proactively identify, prioritize, and complete assigned responsibilities with minimal supervision, Knowledge of good clinical practice (GCP), an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects

Essential Responsibilities

1. Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations. 2. Performs pre-investigation, initiation and routine monitoring to assure that the protocol, obligations, responsibilities, and regulations are established and followed. 3. Monitors subject records for quality, data integrity, and compliance with regulations and organization’s standard operating procedures (SOPs). 4. Prepares materials for Institutional Review Board (IRB) presentation; serves as a resource for the PI. 5. Responsibilities related to regulatory coordination activities include independently managing and preparing submissions of new studies, modifications, renewals, adverse events, and study closures to the IRB, Food and Drug Administration (FDA) and sponsors. 6. Shepherds protocols through the regulatory committee process in a timely manner to ensure activation of trial and for all regulatory aspects of the protocols assigned. 7. 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. 8. Creates training documents and documents staff training based on updates to research protocols. 9. Distributes new protocol information to study team members. 10. Updates model informed consent document from sponsor with local context (boilerplate) language. 11. Maintains 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 IRB and FDA, and sponsor monitors. 12. Maintains 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 and 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 and Other Reporting; Notes to File. 13. Works occasional evenings and weekends as needed. 14. Performs other duties as assigned.