Clinical Research Specialist

Job Description

Are you looking to contribute to groundbreaking research? We look forward to having you join our team to collaborate on 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).

• 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.

• Provides mentorship 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 FDA, HSPC, HIPAA an d 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 supervise 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

Educational Requirements:

Bachelor's Degree in related field preferred.

Master's Degree Preferred.

Licenses:

Basic Life Support (BLS) Certification needs to be the AHA Healthcare Provider Type Only, required/

SoCRA or ACRP or comparable certification

Experience:

5 years of experience in clinical research required.

5 years experience in IRB clinical research application procedures. Related experience in Pharmaceutical/Biotechnology, or Contract Research Organization (CRO), preferred.

5years experience in Phase I, II, III, IV clinical trials and investigator initiated trials, preferred

Physical Demands:

Lifting, standing, walking, sitting

About Us

Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.

About the Team

With a growing number of primary urgent and specialty care locations across Southern California, Cedars-Sinai's medical network serves people near where they live. Delivering coordinated, compassionate healthcare you can join our network of clinicians and physicians to improve the healthcare people throughout Los Angeles and beyond.

Req ID : HRC1413767

Working Title : Clinical Research Specialist

Department : Research - CSMN

Business Entity : Cedars-Sinai Medical Care Foundation

Job Category : Academic / Research

Job Specialty : Research Studies/ Clin Trial

Overtime Status : EXEMPT

Primary Shift : Day

Shift Duration : 8 hour

Base Pay : $40.13 - $62.20

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.