RN Clinical Research Coordinator

Maintains clinical trial operations

Manages and coordinates all aspects of conducting clinical trials within Riverside Health System.

Responsibilities

• Maintains frequent open communication with PI and Clinical Research Coordinator on all protocol requirements and regulatory responsibilities.
• Demonstrates ability to build trusting collaborative relationships with patients and families to facilitate subject retention.
• Addresses concerns and resolves conflict directly and professionally in a respectful manner.
• Assists in the contract/budget negotiation process.
• Maintains accurate financial records to ensure proper billing and accounting for all trial related services and activities.
• Enters data into CTMS accurately and in a timely manner.
• Submission of study related activities are completed and timely.
• Coordinates multiple clinical trials simultaneously or clinical trials with unique complexity.
• Maintains all required documentation for monitors and according to regulatory guidelines.
• Ensures all clinical trials are executed in compliance with ICH/GCP guidelines, regulations, and standard operating procedures.
• Maintains all clinical trial documentation according to guidelines.
• Ensures the randomization procedures, and blinding procedures, if applicable, are followed as per protocol guidelines.
• Works in collaboration with PI and Physicians on prescreening through the electronic health record for potential subjects to participate in the clinical trials.
• Participates and supports all sites auditing and monitoring visits.
• Promptly reports all protocol variances to appropriate parties.
• Provides equitable and confidential treatment to all patients throughout the clinical trial.
• Adheres to HIPAA policies to maintain patient confidentiality.
• In collaboration with Principle Investigator, Clinical Research Coordinator is responsible for initiating the Informed Consent (ICF) process and ensures that no study related procedures are performed prior to obtaining ICF.
• Reviews study protocols and demonstrates knowledge of all procedures and requirements.
• Affirms the integrity and quality of clinical research trial is maintained and conducted in accordance with Good Clinical Practice/ICH guidelines.
• Ensures adherence to the protocol, schedule of events, and other requirements.
• Prepares source documents specific to the studies.
• Affirms quality, completeness, and verifies accuracy of source documents and case report forms collected during the course of the study.
• Ensures information is recorded on case report forms and resolves queries in a timely manner.
• Provides education for patients and families about all aspects of study protocol during all phases from screening through follow-up and closure of the study.
• Prepares all specimens as required by the protocol and adheres to (International Air Transport Association) IATA guidelines.
• Maintains accountability for Investigational Product (IP).
• Prepares and dispenses IP (oral form only can be administered by CRC) per protocol.
• Stores all files in a permanent and safe location.
• Gathers and records all required study related to the Clinical Trial Management System (CTMS).
• Reports all Serious Adverse Events (SAE) to the Principle Investigator, monitor, sponsor, and IRB as required.
• Assesses and records all Adverse Events as outlined in protocol.
• Reports all Serious Safety Events (SAEs) in collaboration with Clinical Research Coordinator to the Principle Investigator, Monitor, Sponsor, and IRB as required.
• Works in collaboration with Investigators and Clinical Research Coordinators to verify eligibility and feasibility of potential trial subjects according to the inclusion/exclusion criteria.
• Prescreens through the electronic medical record for potential subjects.
• Disseminates IRB approved recruitment materials.
• Assesses, documents and reports adverse events (AE) to PI and ensure appropriate follow up as required.
• Prompt notification to IRB/sponsor of any AE classified as serious or unexpected.
• Ensures PI acknowledgment of all safety reports, abnormal test results in a timely manner.
• Adheres to all Human Subject protection guidelines.
• Attends all training sessions related to clinical trials to include Investigator meetings, site initiation visits, and all training related to the conduct of the Trial.
• Works in collaboration with the Clinical Research Coordinator in providing education for all study staff and ancillary departments.
• Instructs patient on the proper usage of investigational product/device.
• Maintains open communication with subjects to ensure adherence to protocol requirements.
• Supports orientation and training of new research team members and other team members with Riverside Health System.

Qualifications

• Bachelor's Degree, Nursing (Preferred)
• 2 years Clinical research or clinical trial coordination experience (Preferred)
• Registered Nurse (RN) - Virginia Department of Health Professions (VDHP) Upon Hire(Required)
• Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (Preferred)
• International Air Transport Association (IATA) (Preferred)
• Collaborative Institutional Training Initiative (CITI) (Preferred)