Clinical Research Coordinator

Salinas Valley Health•Salinas, CA

11d

About The Position

The Clinical Research Coordinator (CRC) manages research studies and clinical research data within the Clinical Research Department. Under the supervision of the Clinical Research Manager and/or a physician, the CRC plans, coordinates, and implements clinical research studies, including regulatory activities, data collection and entry, and IRB follow-up. The role supports additional research projects managed or developed by the department and may provide training, project leadership, and quality-control oversight to entry-level research coordinators. The coordinator is capable of supporting trials across therapeutic areas, with a particular focus on cardiovascular and oncology studies. The CRC assists with management of studies such as NCI-sponsored cancer studies and supports data screening and management for external registry submissions, monitoring and evaluation, and hospital physician-data review. The role requires effective information management and interaction with patients, families, physicians, financial and clinical staff, and information-systems personnel. The CRC identifies and screens potential participants using established criteria, enrolls patients, maintains records, and independently coordinates research and data activities in a hospital or other setting. Working with physicians, clinical staff, the IRB, the Medical Staff Office, and trial sponsors, the CRC supports clinical-trial education, patient care within Good Clinical Practice and human-subject protection guidelines, study start-up and site activation, monitoring, and closure. Responsibilities include maintaining study documentation and investigational product, device, medication, and supply accountability; ensuring complete, accurate, timely, secure, and confidential data; resolving queries; abstracting and auditing data; assessing eligibility, adverse events, and disease response with the investigator; and coordinating required procedures and patient education. The CRC also supports protocol adherence, quality and data-management activities, complaint documentation, SOP development, staff orientation, and cost-effective use of resources. This is a day-shift position with an FTE of 1.0 and 40 scheduled hours. The posted hourly pay range is $30.17–$36.20.

Requirements

Bachelor’s degree required.
Certified Clinical Research Coordinator (CCRC) certification through ACRP or SoCRA required; new hires or transfers have four years from the date of hire or transfer to obtain certification.
Current BLS/Healthcare Provider status meeting American Heart Association standards required; new hires or transfers have a six-month grace period to obtain BLS certification and must maintain current status.
Current CITI Training certificate of completion required; new hires or transfers have a three-month grace period to obtain it and must maintain current status.
Current IATA-approved Shipping & Handling of Dangerous Goods course required; new hires or transfers have a three-month grace period to obtain it and must maintain current status.
Minimum 3–5 years of clinical-trial experience, preferably on the site side working with patients rather than in industry.
Ability to coordinate research and data activities independently in a hospital or other setting.
Ability to interact and collaborate with diverse patients, families, physicians, and staff.
Knowledge and ability to apply Good Clinical Practice, human-subject protection, and applicable regulatory and ethical requirements.

Nice To Haves

One year of experience managing research and/or data projects preferred.
Experience in data entry and ability to work in multiple proprietary programs preferred.
Experience working with patients on the site side of clinical trials preferred.

Responsibilities

Plan, coordinate, and implement clinical research studies, including regulatory work, data collection and entry, and IRB follow-up.
Assist with developing and coordinating other research projects managed or developed by the Clinical Research Department.
Gather and transcribe data into Case Report Forms; maintain regulatory paperwork, databases, and reports.
Preserve and maintain accountability for investigational products, devices, medications, laboratory supplies, and other study-related items.
Support NCI-sponsored and other cancer studies, external data registry submissions, monitoring, evaluation, and hospital data review.
Screen and identify potential research patients using established criteria; enroll patients and maintain patient records.
Collaborate with physicians, clinical staff, the IRB, Medical Staff Office, sponsors, and ancillary departments.
Educate clinical staff about ongoing trials and facilitate patient care consistent with GCP and human-subject protection requirements.
Assist with pre-study activities, required documentation, study training, site visits, site activation, ongoing monitoring, and study closure.
Coordinate patient and family teaching and, in collaboration with the investigator, discharge planning when included in a clinical trial.
Ensure complete, accurate, secure, confidential, and timely collection, calculation, documentation, and preservation of data; resolve data queries promptly.
Interpret clinical information, assessments, laboratory results, and other test results for research and registry documentation.
Maintain accurate investigational device and medication inventory and accountability logs in collaboration with ancillary departments.
Prepare monitoring reports and follow action items through resolution; support data abstraction and audits.
Collaborate with investigators to determine patient eligibility according to study protocols and FDA, IRB, and other regulatory guidelines.
Coordinate procedures for assessing adverse events and disease response; assess, document, and report findings according to applicable policies.
Identify vulnerable patients requiring additional nursing assessment and management; support patient adherence through documentation, education, and study-agent or medication return processes.
Assist with data and quality management, analysis of clinical information, and investigational device or drug complaint documentation.
Apply legal and ethical principles, policies, regulations, and standards for clinical research and data management.
Serve as a liaison between medical staff, other staff, and sponsor clinical research staff; provide site feedback to appropriate departments.
Attend clinical research and study-planning meetings; contribute to SOP review and development.
Participate in training and orientation of new employees and may train, lead, and provide quality oversight to entry-level research coordinators.
Contribute to cost-effective patient care by monitoring use of time, equipment, and supplies; keep the supervisor informed of schedule or workload changes and communicate schedules to study management.
Perform other duties as assigned.