1+ months

Clinical Research Specialist - CA Heart Foundation

Cedars-Sinai Medical Center
Beverly Hills, CA 90209
The Clinical Research Specialist provides clinical research expertise by participating in the design and implementation of research projects 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). **Essential job 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. 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 Serves as an internal consultant for specific departmental activities. 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. Participates in required training and education programs. 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, SAEs and source documents to ensure that research is being conducted according FDA, HSPC, HIPAA an d other agency guidelines. Responsible for insuring timely submission of complete, accurate and neat documents to research sponsors, IRB, and contract research organizations, where applicable. Participates in weekly research staff meetings. 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. Educational Requirements: Associates Degree required BA/BS, MS/MA/MPH degree in related field preferred License/Certifications: SOCRA Certification preferred Experience: + 5 years minimum research specialty with knowledge of IRB clinical research application procedures preferred + Pharmaceutical/Biotechnology or Contract Research Organization (CRO) preferred + Clinical Coordinator experience preferred in Cardiology, Surgery or Infection Disease + Experience in federal grant proposal development and grant submissions, and knowledge of IRB clinical research application procedures preferred Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.

Categories

Posted: 2019-11-18 Expires: 2020-02-16

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Clinical Research Specialist - CA Heart Foundation

Cedars-Sinai Medical Center
Beverly Hills, CA 90209

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast