Clinical Research Associate-Regulatory

Eisenhower Medical Center; United States; Sur place; USD 32 000 - 48 000; Temps partiel

Résumé du poste

Eisenhower Medical Center is seeking a Regulatory Affairs Specialist to develop and maintain clinical trial regulatory documents and protocols for IRB submission. You will ensure compliance with FDA, OHRP, HHS, Eisenhower IRB and sponsor requirements, acting as a resource for investigators and staff.

The role requires at least two years in clinical trials or regulatory work, a bachelor’s degree in healthcare, and GCP/HSR training within 30 days.

Qualifications

• Requires a bachelor’s degree in healthcare or related field and completion of GCP training with HSR course within 30 days of hire.
• Two years of experience with clinical trials or related regulatory work are required.
• Preferred certifications include ACRP CCRC or SOCRA CCRP; certification upon eligibility is expected.

Responsabilités

• Demonstrates compliance with Code of Conduct and compliance policies and reports suspected violations.
• Performs pre-investigation, initiation and routine monitoring to ensure protocol, obligations, and regulations are followed.
• Monitors subject records for quality, data integrity and SOP compliance.
• Prepares materials for IRB presentations; serves as a resource for the PI.
• Manages submissions of new studies, modifications, renewals, AE/SAE reports to IRB, FDA and sponsors.
• Guides protocols through regulatory committee processes to activation.
• Liaises with sponsors and regulatory agencies, coordinates communications with NCTN groups and sponsors.
• Creates training materials and staff training on protocol updates.
• Disseminates new protocol information to study teams.
• Updates model informed consent language to local context.
• Maintains multi-level research network communications with DOTs, IRB, FDA and sponsors.
• Maintains standard regulatory files and documentation packages.
• Occasionally works evenings and weekends as needed.
• Performs other duties as assigned.

Connaissances

Regulatory compliance

IRB liaison

Documentation control

Communication skills

Confidentiality

Formation

Bachelor’s degree in healthcare or related field

Master’s degree preferred

Outils

CITI Program GCP

IRB submission tools

Description du poste

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. Specialties actively engaged in clinical research include Oncology, HIV, Infectious Disease, Gastroenterology, Cardiology, Orthopedics and Pulmonology.

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

Preferred: ACRP CCRC or SOCRA CCRP Certification; certification required upon eligibility

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

Potential Skills, Knowledge, Abilities

Ability to analyze issues, identify root causes, and develop solutions, Ability to create and maintain positive interpersonal relations with peers, staff, leaders and vendors, Ability to maintain high degree of confidentiality, Ability to organize information or data to facilitate easy retrieval and use, Ability to prioritize tasks and manage time efficiently to meet deadlines, Knowledge of medical and pharmaceutical terminology and concepts, as well as theoretical knowledge, Written and verbal communication skills

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.

Welcome to Eisenhower Health Careers! Eisenhower has been a leader in health care for the Coachella Valley since we opened our medical center in 1971. Since then, we’ve been growing steadily, adding services, capabilities and facilities to anticipate and meet the needs of our expanding area. Today, the Eisenhower name extends far beyond the state-of-the-art care we deliver at the hospital.