Title: Clinical Research Cord, Lead

Location: Fountain Valley

Department: Research Admin

Status: Full-Time

Shift: Days

Pay Range*: $41.87/hr - $60.73/hr

MemorialCare 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 MemorialCare'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.

Position Summary

The lead Clinical Research Coordinator (CRC) is a highly-specialized research professional partnering with the Principal Investigator (PI), Co-Investigator(s), department, sponsoring agencies, and/or the Office of Research Administration. The Lead CRC has full autonomy over the daily administrative and technical activities in highly complex, large, nationwide study or multiple moderately complex and concurrent clinical trials involving multiple sites and/or longitudinal assessments/interventions. This role ensures that all activities are completed by strictly following Good Clinical Practice (GCP) and all relevant current local, state, and federal laws, regulations, guidance, policy and procedures developed by the Institutional Review Board (IRB), Food and Drug Administration (FDA), and Code of Federal Regulations (CFR).  

The role of the lead CRC is to guide and mentor the research coordinators and research assistants in the daily assessment, planning, and implementation of research in the studies within their discipline(s). The lead participates in hiring activities; assists in completing performance evaluations; coordinates research staffing and daily assignments; provides mentorship to all research staff; assesses competency of all research staff initially and on an ongoing basis. Acts as a liaison among their unit and all major stakeholders to ensure the goals of the studies are met and are in compliance with research regulations and MemorialCare policies and procedures.   

The Lead CRC develops, manages, and reports on key data; ensures timeliness of data and reporting submissions from multiple investigators; and establishes and implements consistent standards and protocols. This role is responsible for leading the preparation and conduct of internal and external audits; coordinating external surveys; and leading periodic study meetings/teleconferences. 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 Lead CRC trains/mentors CRCI(s) and CRCII(s) on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practice (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical studies. The Lead CRC acts as an advocate for junior clinical research staff by communicating needs and identifying and resolving issues that arise, and identifies staff development needs and provides in-services to staff.  

The Lead CRC may assist in developing and executing strategic and operational plans for clinical research within a department/unit. The Lead CRC will be required to support research activities across several departments/therapeutic areas.  

Essential Functions and Responsibilities of the Job

1. Responsible for independent oversight of assigned studies and training of other clinical research personnel. 

2. Serves as a clinical research project manager on several projects across the health system. In addition to managing their assigned trials, the Lead CRC will assist with other trials as needed.  

3. Ensures compliance with all federal and local agencies including the FDA and IRB. Master all divisional SOPs as well as HRP SOPs in order to offer appropriate and correct direction to junior research staff.  

4. Accountable for high standards of clinical research practice and assists in the development of   accountability in others by providing leadership to fellow CRC I and CRC II colleagues.  

5. Participates in the after-hours support and coverage schedule, if necessary.  

6. Be at work and on time. 

7. Follow company policies, procedures and directives. 

8. Interact in a positive and constructive manner. 

9. Prioritize and multitask. 

*Placement in the pay range is based on multiple factors including, but not limited to, relevant years of experience and qualifications. In addition to base pay, there may be additional compensation available for this role, including but not limited to, shift differentials, extra shift incentives, and bonus opportunities. Health and wellness is our passion at MemorialCare—that includes taking good care of employees and their dependents. We offer high quality health insurance plan options, so you can select the best choice for your family. And there’s more...Check out our MemorialCare Benefits for more information about our Benefits and Rewards.

Qualifications/Work Experience:

• Minimum of seven (7) years of clinical research experience required.  

• Experience coordinating multiple trials simultaneously and a variety of studies (e.g. investigator-initiated; industry-sponsored; government/cooperative group-sponsored; multi-site trials; observational and interventional) and across multiple therapeutic areas required.  

• Knowledge of clinical trial federal, state and local regulations required.  

• Working knowledge of Good Clinical Practice (GCP) required.  

• Ability to participate in protocol review and clinical trial evaluations required.  

• Ability to train junior CRCs with appropriate and correct direction required.  

• Strong project management, analytical, organizational, and problem-solving skills required.  

• Excellent time management and ability to prioritize work assignments independently required.  

• Superior interpersonal and communication skills required.  

• Knowledge of regulatory affairs processes in order to independently facilitate IRB submissions (initial submissions, amendments, continuing renewals, etc.) required.  

• Ability to read and understand clinical trial protocols 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.   

Education/Licensure/Certification:

• Associates degree or equivalent education required. 

• Bachelor’s degree strongly preferred.  

• Master’s degree in relevant field preferred. 

• Research certification (e.g. ACRP, SoCRA or equivalent) required.  

• Phlebotomy certification preferred.   

• 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.