Clinical Research Coord, II

MemorialCare•Fountain Valley, CA

2d•Onsite

About The Position

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.

Requirements

Minimum of four (4) years of clinical research experience required.
Experience coordinating more than one type of clinical research study (e.g., investigator-initiated, industry sponsored, and multi-site trials; observational and interventional) required.
Experience conducting clinical research in more than one therapeutic area required.
Knowledge of clinical trial federal, state and local regulation requirements required.
Excellent interpersonal and communication skills required.
Ability to read and understand clinical trial protocols required.
Demonstrated ability to work on deadlines, set priorities and handle competing demands with enthusiasm and without compromising quality required.
Strong data management skills and attention to detail required.
Familiarity with medical terminology/environment required.
Extensive knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) required.
Associates degree or equivalent education required.
Research certification (e.g. ACRP, SoCRA or equivalent) required.
Current CITI training required.
Must maintain a valid driver’s license and automobile insurance as travel to physician offices and health system locations is required for departmental specific job duties.

Nice To Haves

Bachelor’s degree preferred.
Phlebotomy certification preferred.

Responsibilities

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.
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.
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.
Collects, processes, ships and stores specimens to appropriate laboratory according to established aseptic techniques.
Independently creates comprehensive source documents if not provided by trial sponsor.
Performs assessments to monitor for and identify adverse events and protocol deviations or violations, noting severity and causality and attribution of the adverse events; reports findings to PI, sponsor and IRB under general direction of department, clinical research manager and/or Director. It is the expectation that the CRC II will complete study visits with few to no deviations on a consistent basis.
Organizes and actively participates in site visits from sponsors and other relevant study meetings. It is the expectation that the CRC II will receive stellar feedback via Interim Monitoring Visit reports with few to no corrections required on a consistent basis. If corrections are needed, these issues are resolved prior to the next monitoring visit.
Exhibits professionalism in all aspects of job duties (email correspondence, colleague relationships, dress code, office behavioral conduct). Demonstrated initiative to set regular meeting schedule with research team and facilitate independent communication within team.
Participates in the after-hours support and coverage schedule, if necessary.
Be at work and be on time.
Follow company policies, procedures and directives.
Interact in a positive and constructive manner.
Prioritize and multitask.