Clinical Research Coord, II

Title: Clinical Research Coordinator II

Location: Fountain Valley, CA

Department: Research Administration

Status: Full-time

Shift: Day

Pay Range*: $39.12/hr-$56.75/hr

Memorial Care is a nonprofit integrated health system that includes four leading hospitals, award-winning medical groups – consisting of over 200 sites of care, and more than 2,000 physicians throughout Orange and Los Angeles Counties. We are committed to increasing access to patient-centric, affordable, and high-quality healthcare; your personal contributions are integral to Memorial Care's recognition as a market leader and innovator in value-based and other care models.

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 II (CRC II) is a specialized researcher responsible for providing support for clinical research protocols. The Clinical Research Coordinator II will assist the Research Administration department with all aspects of clinical research. This individual will interact with subjects, clinic and research staff, laboratory staff, radiology staff and any other medical professionals associated with our clinical research protocols.

The CRC II works both independently and with the PI, Co-Investigator(s), department, and sponsoring agencies to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study. With limited supervision and/or guidance the CRC II facilitates study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.

The CRC II independently manages, facilitates and monitors the daily activities of multiple moderately complex clinical trials and performs a variety of duties involved in the collection, compilation, documentation and reporting of clinical research data. 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.

The CRC II may assist with the training and/or mentoring of CRC I or other CRC II staff on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical study. The CRC II will provide appropriate and accurate direction to junior staff, when needed.

1. Independently manages all aspects of conducting clinical trials from startup to closeout for multiple concurrent moderately complex clinical trials (across multiple therapeutic areas) that may include national level, multi-institutional pharmaceutical trials and multi-centered cooperative group and intergroup studies. Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.

2. Plans and coordinates subjects’ schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.

3. Responsible for the oversight/monitoring of all clinical trial expenses; reviews the protocol plan to differentiate standard of care versus research to ensure that clinical care expenses, personnel effort, site initiation costs, IRB fees, pharmacy costs, equipment, and supplies are tracked and captured as direct costs to the clinical trial.

4. Collects, processes, ships and stores specimens to appropriate laboratory according to established aseptic techniques.

5. Independently creates comprehensive source documents if not provided by trial sponsor.

6. Performs assessments to monitor for and identify adverse events and protocol…