Job Description
Newport News, Virginia
Overview Works in collaboration with the Clinical RN Research Coordinator, other Physicians and other team members related to the clinical trial. Performs 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. Utilizes knowledge of protocol requirements to ensure studies are properly conducted in conformance with the protocol guidelines, department standards, and GCP (Good Clinical Practice) as set forth by government regulations. Manages and coordinates 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. Maintain a professional courteous and considerate demeanor in all interactions with practice, facility and support services team members, research team members, caregiver, patients, and visitors. Addresses concerns and resolves conflict directly and professionally in a respectful manner.
- Utilizes good time management and organization skills to complete job duties within scheduled work hours. Actively seek ways, projects, and clinical trials to maintain optimal productivity during low volume intervals. Demonstrates ability and willingness to cross train and float to other research sites as needed. 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 site SOPs. 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 RN Research Coordinator to the Principle Investigator, Monitor, Sponsor, and IRB as required. Records all Adverse Events as outlined in the protocol.
- 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 acknowledgement 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 other trainings related to the conduct of the Trial. Must complete and recertify on CITI training according to Riverside IRB guidelines. Maintains IATA certification. Assesses the need for staff education in all areas where the research will be conducted, in conjunction with the responsible Clinical Research Coordinator, Manager of Practices, Nursing Teams and Support Team Members and develops a plan for staff education. Works in collaboration with the Clinical Research Coordinator in providing inservice 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 the orientation and training of new research team members and other team members with Riverside Health System.
Qualifications
Education - Bachelors Degree, Healthcare or Related (Required)
Experience
- 2 years Clinical research (Preferred)
Licenses and Certifications
- IATA - Special Cargo Certification - International Air Transportation Association (IATA) within 1 Year(Required)
- Collaborative Institutional Training Initiative (CITI) (Preferred)
To learn more about being a team member with Riverside Health System visit us at .
Job Tags
Permanent employment, Full time, Local area,