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Title: Clinical Research Coordinator, Lead

Location: Fountain Valley

Department: Research Administration

Status: Full-Time

Shift: Days

Pay Range*: $43.13/hr - $62.55/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 ocomplex, 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. Oversee and participate in the independent coordination and conduct of complex clinical research studies and ensure compliance with federal and local regulations.
2. Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning, maintain records, track progress, compile/analyze data and conduct quality assurance activities.
3. Act as a liaison with medical staff, ancillary departments/service lines and satellite facilities.
4. Serve as a resource person or act as a consultant within area of clinical research expertise; act as a leader within the department/unit through improving clinical research practice.
5. Lead and train clinical team members including clinical research coordinators and investigators on good clinical practice (GCP), informed consent process and documentation and ensure compliance.
6. Responsible for identifying new clinical research opportunities.
7. Lead teleconferences, on site meetings and off-site investigator meetings, as required. Host site initiation visits and monitoring/auditing visits.
8. Maintain working knowledge of current protocols and internal SOPs.
9. Provide excellent customer service experience for patients; responding to patient needs in a timely manner.
10. Provide investigators with guidance regarding protocol requirements.
11. Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data Safety Review Committee.
12. Acquire regulatory affairs training in order to assist staff with various IRB submissions in times of need.
13. Lead the preparation and conduct of audits, inspections, and monitoring visits from regulatory agencies and sponsors.
14. Participate in enterprise-wide committees that will serve to enhance the clinical research program and perfect divisional processes.
15. Attend continuing education and training opportunities relevant to job duties. This research-related continuing education should be shared with fellow research staff in monthly seminars to enhance clinical research program.
16. Collaborates with research physicians, manager and clinical coordinators to develop and implement strategies for enrolling patients into clinical trials
17. Assists with the completion of site qualification questionnaires and participated in site qualification visits. for new studies
18. Assists with start-up budget review
19. Ensures all billable study related activity is added to appropriate database systems and EDC for billing purposes
20. In collaboration with the manager, organize and schedule site initiation visits (SIV) and roll out of new studies
21. Participate in training and receive access to sponsor electronic portals (EDC, imaging repository, etc.) to serve as a back-up to the coordinator if needed and to ensure data quality
22. Oversee the screening process to identify strategies to maximize enrollment and troubleshoot barriers to meet enrollment goals
23. Conduct quality assurance including post consent calls, inclusion/exclusion verification, proper informed consent, accurate and timely data entry
24. Gather study-specific protocol deviations and create preventative and corrective action plans to avoid future errors
25. Communicate unit activities regularly to the Manager
26. Assists in the generation of research progress reports as needed  
27. Assists the primary RC with the initial DOA to ensure delegations are appropriate, start date matches sponsors expectations, activation letters received
28. Ensures RC have a process to communicate with the PIs (i.e., either a pi meeting or emails as needed)
29. Communicates new protocols to the outpatient clinic areas and the inpatient locations highlighting how the protocol diverges from SOC and ways the protocol could impact clinical workflow
30. Ensure research product is received and stored properly, ensures supplies required for the research are stocked.
31. Creates compliance checklists for the rc to use as a roadmap to ensure all data is collected per protocol
32. Ensure the primary RC updates the source as needed for eCRF updates, protocol modifications, improvement of process due to PDs 
33. Protocol deviation caps, for major deviations work with PI and research leadership
34. Immediately communicates and/or consults with Dir or AD on compliance related matte
35. "Other duties as assigned"

*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.

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

• 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.