"Clinical Research Specialist - The Angeles Clinic & Research Institute"

Job Description

Grow your career at Cedars-Sinai!

The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all our patients with cancer.

Why work here?

Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for.

Join our team and contribute to groundbreaking research.

The Clinical Research Specialist provides clinical research expertise by participating in the design and implementation of research projects and care of research patients as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and Responsibilities:

• Provides clinical research expertise by participating in the design and implementation of research projects and care of research patients as needed by the department or institution.
• Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
• Coordinates research projects at an institutional or departmental level. Serves as an internal consultant for specific departmental activities.
• Communicates project status and improvement areas with leadership in a timely manner. Projects may include but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees.
• Implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.
• Provides guidance regarding project planning, project logistics, and project implementation.
• Participates in required training and education programs. Participates in weekly research staff meetings.
• Provides clinical expertise and support with quality assurance, performance improvement, and health plan compliance for clinical trial compliance.
• Ensures the completion and maintenance of consent forms, case report forms, SAE’s and source documents to ensure that research is being conducted according to FDA, HSPC, HIPAA and other agency guidelines.
• Completes appropriate IRB paperwork and submission/filing of internal and external SAEs to IRB. Responsible for insuring timely submission of complete, accurate and neat documents to research sponsors, IRB, and contract research organizations, where applicable.
• Acts as a liaison with Principal Investigators, pharmaceutical company representatives and other project funding organizations to monitor and update project progress.
• Prepares for institutional, pharmaceutical and internal audits, including facilitating third party study monitoring.
• Attends site feasibility visits and site initiation visits for potential studies and assures that new studies are implemented according to protocol.
• Review pertinent medical records to determine opportunities for quality improvement. Analyze quality metric data in support of the Principal Investigator and Director of Clinical Services. Recommend and implement process improvement efforts.
• Assists with procedures and supports related patient care when required during data collection process.

Qualifications

Job Qualifications:

• Bachelor's Degree preferred.
• 5 years of experience in clinical research is required.
• 5 years of experience in IRB clinical research application procedures preferred. Related experience in Pharmaceutical/Biotechnology, or Contract Research Organization (CRO).
• 5 years of experience in Phase I, II, III, IV clinical trials and investigator-initiated trials preferred.