Clinical Research Coord

Job Description

Clinical Research Coord, I - ( MEM
010072 )

Description

Title: Clinical Research Coordinator I

Location: Fountain Valley/Long Beach

Department: Research Admin

Status: Full Time

Shift: Days

Pay Range*: $37.27/hr - $54.01/hr

At Memorial Care Health System, we believe in providing extraordinary healthcare to our communities and an exceptional working environment for our employees. Memorial Care stands for excellence in Healthcare.

Across our family of medical centers, we support each one of our bright, talented employees in reaching the highest levels of professional development, contribution, collaboration and accountability.

Whatever your role and whatever expertise you bring, we are dedicated to helping you achieve your full potential in an environment of respect, innovation and teamwork.

The Clinical Research Coordinator fulfills the requirements of recruiting, enrolling and conducting follow-up of study participants in clinical trials related to all therapeutic areas represented throughout Memorial Care. In doing so, the Clinical Research Coordinator I is responsible for coordinating trial participation of study volunteers with the trial’s protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.).

The Clinical Research Coordinator I is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol. After hours support and coverage may be needed to adequately meet the needs of the research subject and/or adhere to the protocol recruitments. After-hours Support Staff will be compensated for his/her time providing support during these after hours.

• Under direct supervision of the Director of Clinical Operations, Manager of Clinical Operations and principal investigator, the CRC 1 is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants in clinical trials.
• Collaborates with study investigator in determining eligibility of potential participants in clinical trials.
• Screens potential participants for protocol eligibility. Presents trial concepts and details to the participant, participates in the informed consent process, and enrolls participants in study protocol.
• Ensures research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
• Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide participants’ education regarding medication administration. Maintains investigational drug accountability, when needed, in cases where the Research Pharmacy is not maintaining that responsibility.
• In collaboration with the study investigator, reviews study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
• Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
• Maintains current and accurate documentation in the regulatory binder(s) as required by regulations and sponsors.
• Participates in required training and education programs. Responsible for education of other personnel and vendors regarding clinical research.
• Provide a safe environment for study participants, caregivers, and study personnel at all times through…