RN Clinical Research Lead

Gloucester, Virginia

Overview

Works under the guidance and direction of the Clinical Research Manager. The Lead Clinical Research Nurse Coordinator is responsible for assisting with protocol review, feasibility and selection, contract review and budget negotiations. Actively participates in the planning and evaluation processes to improve and advance clinical research within the organization. Works closely with Physicians, Clinical Research Manager, Clinical Research Coordinators and Research Clinical Nurse Coordinators to determine eligibility of patients for clinical trials. Responsible for enlisting and maintaining patients on assigned protocols and assisting Clinical Research Coordinators and Clinical Research Nurse Coordinators with screening, enrolling and follow up of all study patients.

What you will do

Collaborates closely with the Director of Research and Discovery, RMG non-oncology physicians, service line leadership and operational areas. .Maintains frequent open communication with PI 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. Establish and maintain collaborative relationship with outside Sponsors, CRO’s and medical liaisons to identify potential opportunities for growth.

Facilitates and maintains open communication with leadership, physicians and all research staff to provide departmental updates and ensure open dialogue and collaborative problem solving. Addresses concerns and resolves conflict directly and professionally in a respectful manner.

Works closely with the Director of Research and Discovery and RHS legal team in the contract/budget negotiation process. Collaborates with Research Support Coordinator to ensure proper billing and accounting for all trial related services and activities. Enters data into CTMS accurately and in a timely manner. Monitors financial performance for non-oncology clinical research trials and diligently works to meet targeted financial goals.

Utilizes good time management and organization skills to complete job duties within scheduled work hours. Actively seek ways and projects to maintain optimal productivity during low volume intervals. Demonstrates ability and willingness to cross train and float to other research sites as needed.

Serves as a resource to other study personnel to ensure all clinical trials are executed in compliance with ICH/GCP guidelines, regulations and site SOPs. Maintains all Trial documents according to guidelines. Participates in and supports all sites auditing and monitoring visits. Assist in preparation of regulatory documents for study startup. Maintain regulatory binder throughout course of the study according to regulatory guidelines. Participates in and supports all site monitoring/auditing visits. Promptly reports all protocol variances to appropriate agencies. Provides equitable and confidential treatment to all patients throughout the clinical trial. Adheres to HIPAA policies to maintain patient confidentiality. In collaboration with the Principle Investigator, Coordinator is responsible for initiating the Informed Consent (ICF) process and ensures that no study related procedures are performed prior to obtaining ICF.

Serves as a resource to all non-oncology study coordinators for the review of protocols and assures all trial related activities are conducted in accordance with all federal, state and local regulations. Demonstrate knowledge of all procedures and requirements. Assures that the integrity and quality of the clinical research trial is maintained and that the trial is 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. Prepares all specimens as required by the protocol and adheres to IATA guidelines. Maintains accountability for Investigational Product (IP). Prepares and dispenses IP according to protocol. Gather and record all required study related to the Clinical Trial Management System (CTMS).

Provides guidance to non-oncology clinical research coordinators/nurses in the identification of potential subjects through Electronic Health Record searches, physician referral, etc. Works in collaboration with Investigator to verify eligibility of potential trial subjects according to the inclusion/exclusion criteria. Prescreens electronic medical records for potential subjects. Collaborates with non-oncology research coordinators/nurses to develop and implement a recruitment strategy and study management plan and monitor progress. Demonstrates ability to attract new clinical research trials. Collaborates closely with leadership and operational areas for protocol selection and appropriate, targeted growth of the non-oncology research program. Pursue institutional or community based resources or groups that can assist in achieving recruitment goals. 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 acknowledgement of all safety reports, abnormal test results in a timely manner. Ensures adherence to all Human Subject protection guidelines.

Provides training to non-oncology research staff as needed. Attends all training sessions to include Investigator meetings, site initiation visits, and all other training related to the conduct of the Trial. Must complete and recertify on CITI training according to Riverside IRB guidelines. Maintains IATA certification. Responsible for providing in-service education to all study staff and ancillary departments. Instructs patient on the proper usage of investigational product/device. Maintains open communication with subjects to ensure adherence of protocol requirements.

Qualifications

Education

Bachelors Degree, Nursing (Preferred)

Program Graduate, Registered Nurse (Required)

Experience

Clinical research (Required)

Licenses and Certifications

Registered Nurse (RN) - State Department of Health Professions Upon Hire(Required)

Certified Clinical Research Coordinator, International Air Transport Association (IATA) or Collaborative Institutional Training Initiative (CITI) (Preferred)

To learn more about being a team member with Riverside Health System visit us at