Newport News, Virginia
Hiring Range$68,000.00 - $93,500.00/AnnualActual pay is determined based on job-related factors such as relevant experience, education, credentials, skills, internal equity, and business needs.
OverviewPerforms duties related to the conduct of clinical trials in accordance with RHS policies, protocol requirements as well as all local, state, and federal regulations/guidelines. Works closely with the Principle Investigator (PI), members of the research team, physicians, study sponsors and monitors and IRB (Internal Review Board) to provide guidance on administration of the compliance, financial, contracts, and other regulatory aspects of clinical studies. Manages and coordinates all aspects of conducting clinical trials within Riverside Health System.
What you will do- 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. Assures 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. Assures 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.
QualificationsEducation- Bachelors Degree, Nursing (Preferred)
Experience- 2 years Clinical research or clinical trial coordination experience (Preferred)
Licenses and Certifications- 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)
