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WellSpan Health · 1 month ago

RN Research Coordinator - Heart Vascular Research - Days

York, PA

Full-time

Onsite

Entry, Mid Level

2+ years exp

WellSpan Health is an integrated delivery system focused on leading in value-based care. They are seeking an RN Research Coordinator to coordinate clinical research activities, ensure compliance with study requirements, and support ongoing patient management in the heart and vascular research area.

Health CareHospitalMedical

Responsibilities

Participates in the review of research protocols and assesses the appropriateness, feasibility and resource requirements for implementation. Serves as the principle liaison for project, developing plans and tools as needed to conduct research. Performs nursing responsibilities for nursing care based on research study requirements

Assists investigators in evaluating the quality of care and compliance to protocol requirements. Follows by ensuring compliance with all guidelines for human subject protection and research

Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, management, sponsors, and/or regulatory bodies. Ensures billing of study procedures to the appropriate funding source if needed

Maintains an excellent working knowledge of all protocols. Develops and conducts formal and informal education to inform clinical and other staff of implications of protocol procedures. Distributes protocol and patient information in a timely manner

Oversees patient pretreatment, eligibility and informed consent documentation requirements are met as per the GCP, FDA and IRB guidelines. Registers and accomplishes randomization of patients enrolled in research studies. Documents record of institutional patient registration

Coordinates, observes and/or records data for protocol therapy. Monitors dosage modifications and actively participates in assessing patients for toxicity and response using chart review and physical assessment skills and communication with physicians and nurses

Evaluates and identifies potentially eligible protocol patients, and verifies according to protocol requirements. Provides direct patient education regarding protocol participation, and provides additional information as appropriate. Ensures the integrity of the informed consent process and assists in obtaining informed consent from patients. Works with internal and external registration and scheduling personnel as appropriate to facilitate study entry

Coordinates, observes and/or records data for protocol therapy. Actively participates in assessing patients for toxicity and response using chart review and physical assessment skills and communication with physicians and nurses

Adheres to all protocol requirements to ensure validity of clinical research patient data. Submits complete and accurate forms and materials to external agencies as required in accordance with protocol requirements

Coordinates protocol-related patient activities to ensure protocol compliance and optimal patient scheduling. Designs and compiles forms and educational materials to aid physicians and staff in complying with protocol requirements including tests and follow up visits

Monitors and facilitates necessary documentation in the conduct of clinical research studies. Regularly reviews protocol study forms for accuracy and compliance to protocol standards. Performs consistency checks, edits for errors, and monitors timeliness of data submission. Identifies system inadequacies and augments the system as necessary

Prepares and/or processes adverse event reports on protocol patients and submits these to the principal investigator and appropriate agencies. Alerts investigators and appropriate personnel of communications received regarding adverse events or drug reaction reports or investigational device related issues

Oversees the receipt, secure storage and dispensing of medications provided for protocol patients. Reviews investigational drug logs and inventories to assure that appropriate documentation is maintained and federal guidelines are met

Coordinates all site visit audits. Gathers records and other necessary materials required for audits. Reviews records with all site visit teams and responds to audit reports in a timely manner

Develops and maintains effective and ongoing communication with clinical research participants, the Sponsor and PI. Acts as a liaison between national cooperative groups, institutional investigators, staff and affiliate groups

Triages patient calls, attending to or resolving problems and answering questions

Suggests improved methods for accomplishing research goals

Remains flexible with scheduling to ensure that active research trials and clinical research participants are covered

Travels to additional WellSpan sites as required to execute trials

Attends and participates in research team meetings; educational research and clinically relevant workshops to maintain skill set, knowledge base and continuing educational credits

Qualification

Clinical research coordinationNursing responsibilitiesPatient educationMedical research ethicsRegulatory complianceData collectionCommunication skillsTeamworkProblem-solvingFlexibility

Required

Bachelor's Degree Required

2 years' experience in nursing, medical research, or clinical trials required

Training/experience in the responsible conduct of research, including medical/ research ethics and protection of the safety and welfare of human subjects in research required

Licensed Registered Nurse Upon Hire Required

Registered Nurse Multi State License Upon Hire Required

Heartsaver CPR/AED Upon Hire Required