Job DescriptionThe Regulatory Coordinator II prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS, Cedars-Sinai IRB, External IRB, IACUC and any research committee involved in the Pre-Award/Post-award process. This role submits continuations, amendments, responds to questions, generates
reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Research Department when meeting with sponsors, attending team meetings, and working with other staff to ensure all regulatory documents and requirements are
met and up-to-date. May plan and coordinate strategies for improving efficiency, action plans to improve quality, and training and education of personnel.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties & Responsibilities- Prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS (if needed), Cedars-Sinai IRB, External IRB, IACUC and any research committee involved in Pre/Post-award process.
- Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
- Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study.
- Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
- Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
- Meets with monitors from pharmaceutical companies and represents the Medical Center during these meetings.
- Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
- Attends research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
- Participates in required training and education programs and may provide training and education of other personnel.
- May participate in centralized activities of the department or institution.
- May plan and coordinate strategies to improve existing standard operating procedures related to regulatory
- Affairs including drafting SOP's and/or job aids.
- May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Responsibilities- Responsible for clinical study activities, coordination, adherence to protocols and serves as a liaison between study participants, Principal Investigator (PI), and other research staff.
- Provides educational services to research participants and family regarding study participation, participants current clinical condition, and or disease process.
- Assesses and documents adverse events as reported by research participants, works closely with PI to document according to department process (grade, attribution, treatment, etc.), and reports to regulatory and sponsor as required.
- Records research data where assessed or reported by patient (i.e. symptoms of treatment).
- Creates and presents education materials to the interdisciplinary team to on study requirements.
- Collaborates with the interdisciplinary team to create and communicate a plan of care.
- Triages patient by phone and provides clinical information to the patient.
- Completes and documents study participant enrollment, assessment/reassessment, education, and follow-up activities and ensures protocol is followed.
- Coordinates study participant tests and procedures as required.
- Prepares data spreadsheets for Investigator and/or department.
- Performs general oversight of research portfolio as it pertains to the clinical coordination of the studies.
- Serves as a resource and mentor to other research staff by providing training, work review and leading staff.
- Provides guidance, instruction and expertise to team members on study requirements and clinical coordination of the studies.
- May assist with grant proposals, publication preparation, and/or presentations.
- May process, ship, track or otherwise handle research specimens.
QualificationsEducation
- Bachelor's Degree Nursing or Health Science - minimum
- Master's Degree Nursing or Health Science - preferred
Experience
- 5 years Clinical nursing experience - minimum
- 5 years Clinical research experience - minimum
Licenses and Certifications
- RN State License - Upon Hire minimum California
- Basic Life Support - Upon Hire minimum
- Certification In Clinical Research - 1 Year minimum SOCRA or ACPR
