Clinical Research Coordinator

Salinas Valley Health•Salinas, CA

12d•$30 - $36

About The Position

The Clinical Research Coordinator (CRC) manages research studies and clinical research data. Under the supervision of the Clinical Research Manager and/or a physician, the CRC participates in planning, coordinating, and implementing clinical research studies, including regulatory activities, data collection and entry, and IRB follow-up. The role also supports other research projects managed or developed by the SVMHS Clinical Research Department. The CRC may train and provide project leadership and quality-control oversight to entry-level research coordinators, and coordinates trials across therapeutic areas, with particular focus on cardiovascular and oncology trials. The CRC supports research data management, including cancer studies sponsored by the NCI and organizations such as the Eastern Cooperative Oncology Group. The role screens and manages data for external registry submissions, monitoring and evaluation, physician data, and hospital review functions, and disseminates information in accordance with HIPAA guidelines. The CRC applies clinical knowledge to identify and screen potential research patients, enrolls them, and maintains their records. The position coordinates research and data activities independently in a hospital or other setting and collaborates with physicians, clinical staff, the IRB, the Medical Staff Office, and clinical trial sponsors. The CRC follows Good Clinical Practice (GCP), human-subjects protections, and applicable legal, ethical, regulatory, and institutional standards while supporting patient care and study conduct. The role coordinates study start-up, activation, monitoring, and closure; maintains regulatory documentation and investigational product, device, medication, and laboratory supply records; ensures accurate and timely collection, entry, abstraction, and preservation of data; resolves data queries; supports patient eligibility and safety assessments; schedules protocol-required procedures; documents adverse events and disease response; and participates in audits, reporting, training, SOP development, and other research activities. The CRC also contributes to cost-effective care and keeps supervisors and study management informed of workload and scheduling changes.

Requirements

Bachelor’s degree required.
Certified Clinical Research Coordinator (CCRC) certification through ACRP or SoCRA required; new hires and transfers have four years from hire or transfer to obtain certification.
Current BLS/Healthcare Provider status under American Heart Association standards required; new hires and transfers have a six-month grace period to obtain BLS certification and must maintain it.
Current CITI Training certificate of completion required; new hires and transfers have a three-month grace period to obtain it and must maintain it.
Current IATA-approved Shipping & Handling of Dangerous Goods course required; new hires and transfers have a three-month grace period to obtain certification and must maintain it.
Minimum 3–5 years of clinical trial experience.
Ability to coordinate research and data activities independently in a hospital or other setting.
Ability to interact with ethnically diverse patients, families, physicians, financial staff, clinical staff, and information systems.
Ability to apply clinical knowledge and assessment skills to patient screening, eligibility, safety, and research data activities.
Ability to manage clinical research data and maintain confidentiality in accordance with HIPAA and applicable legal, ethical, regulatory, and institutional requirements.

Nice To Haves

Clinical trial experience working with patients on the site side rather than in industry is preferred.
One year of experience managing research and/or data projects is preferred.
Experience in data entry and ability to work in multiple proprietary programs are preferred.

Responsibilities

Plan, coordinate, and implement clinical research studies, including regulatory activities, data collection and entry, and IRB follow-up.
Support development and conduct of other research projects managed or developed by the SVMHS Clinical Research Department.
Gather and transcribe data into Case Report Forms; maintain regulatory paperwork, study-related supplies, investigational products, databases, and reports.
Coordinate clinical trials across therapeutic areas, with particular focus on cardiovascular and oncology trials.
Provide training, project leadership, and quality-control oversight to entry-level research coordinators as needed.
Manage and screen research data for external registry submissions, monitoring and evaluation functions, physician data, and hospital review functions; disseminate information in accordance with HIPAA guidelines.
Identify and screen potential research patients using established criteria; enroll patients and maintain their records.
Collaborate with physicians, clinical staff, the IRB, the Medical Staff Office, sponsors, ancillary departments, and other functional departments.
Educate clinical staff about ongoing clinical trials and support teamwork and conflict resolution through positive communication and collaboration.
Follow GCP guidelines and facilitate patient care within human-subjects protection requirements.
Coordinate pre-study activities, submit required documentation, maintain study device and medication inventory, complete required training, and participate in site visits.
Collect documentation for site activation and assist with ongoing study monitoring and study closure.
In collaboration with investigators, support discharge planning and patient or family teaching related to clinical trials.
Ensure complete, accurate, timely collection, calculation, documentation, security, confidentiality, and preservation of research data; resolve data queries promptly.
Interpret clinical information, assessments, laboratory results, and other test results for accurate registry and research data recording.
Maintain accurate accountability of investigational devices and medications and coordinate drug or device accountability logs with ancillary departments.
Prepare timely and accurate monitoring reports, follow action items through resolution, complete data abstraction, and participate in data audits.
Collaborate with investigators to determine study-patient eligibility according to protocols and FDA, IRB, and other regulatory guidelines; ensure scheduling of required procedures to assess adverse events and disease response.
Assess, document, and report adverse events in collaboration with investigators, following hospital, IRB, FDA, and sponsor policies.
Evaluate disease response and physical assessment data with the principal investigator according to study protocols.
Identify vulnerable patients who require increased nursing assessment and management beyond clinical-trial requirements.
Support and evaluate patient adherence to study protocols through documentation, education, and study agent or medication return processes.
Assist with data and quality management activities and analysis of clinical information as required.
Assist with compilation of investigational device or drug complaint documentation.
Apply legal and ethical principles, policies, regulations, and standards to the control and use of clinical research and data.
Serve as a liaison among medical staff, staff, and sponsors’ clinical research staff; provide site feedback to appropriate departments.
Attend in-house clinical research meetings and other required study-planning meetings.
Contribute to ongoing review and development of Standard Operating Procedures.
Participate in training and orientation of new employees.
Promote cost-effective patient care by monitoring use of time, equipment, and supplies.
Keep the supervisor informed of changes in work schedule or workload and communicate schedules to study management.
Perform other duties as assigned.