Clinical Research Coordinator - Heart & Vascular Research

York, PA | Nursing | Tracking Code: 57822

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Position Summary:

Monday - Friday (W/Occasional weekend)

 

 

General Summary:

 

 

Under general supervision, coordinates clinical research activities and compliance to study requirements, and patient and staff considerations relative to specific clinical trials and/or studies. Monitors the clinical course and collection of research data for patients in clinical trials. Assists the medical investigators in achieving the objectives of clinical research studies, and supports ongoing patient management approaches in the designated disease/treatment area(s). Considers nursing implications in areas of staff and patient educational needs, staff resources, and research objectives. Acts as a resource for clinical and support staff involved in the care of patients enrolled in appropriate studies. Coordinates and performs nursing responsibilities in specialty area(s) for clinical research patients.

 

 

Duties and Responsibilities:

 

 

1 Participates in the review of research protocols and assesses the appropriateness, feasibility and resource requirements for

implementation. Develops plans as needed to address patient care and staffing requirements.

2 Assists investigators in evaluating the quality of care and compliance to protocol requirements. Initiates corrective action

as needed. Ensures that there is documented Institutional Review Board approval for protocols and consent forms prior

to patient enrollment.

3 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.

4 Ensures that patient pretreatment, eligibility and informed consent documentation requirements are met prior to patient

enrollment/registration in a research study. Registers and accomplishes randomization of patients enrolled in research

studies. Documents record of institutional patient registration.

5 Collaborates with nursing staff in assessing, planning, implementing and evaluating the nursing care of the patient

population specific to clinical research studies. Monitors dosage modifications and treatment calculations and assesses

patients for toxicity and response.

6 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.

7 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.

8 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.

9 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.

10 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.

12 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.

13 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.

14 Maintains cooperative relations with clinical research participants. Acts as a liaison between national cooperative groups,

institutional investigators, staff and affiliate groups.

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

16 Suggests improved methods for accomplishing research goals.

Required Skills

Minimum Education

Bachelor's Degree

 

 

Preferred Education

Master's Degree

 

 

Req Cert/Registration

Registration and current RN license in PA; CPR certification

 

 

Pref Cert/Registration

Appropriate RN specialty certification; National certification, clinical research/trials coordinator or clinical research associate (e.g., Association of Clinical Research Professionals

(ACRP), Society of Clinical Research Associates (SOCRA))

Required Experience

Minimum Experience

2 - 3 years 

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


Quality of Life

WellSpan Health is an integrated health system that serves the communities of central Pennsylvania and northern Maryland. The organization is comprised of a multispecialty medical group of more than 1,500 physicians and advanced practice clinicians, a regional behavioral health organization, a home care organization, eight respected hospitals, more than 19,000 employees, and 170 patient care locations. WellSpan is a charitable, mission-driven organization, committed to exceptional care for all, lifelong wellness and healthy communities. We are committed to transforming the health of the communities we serve and to educating the next generation of clinicians, staff and leaders.

Quality of Life
Quality of Life

Founded in 1741, the city of York is considered by many as the first capital of the United States. The Articles of Confederation were signed by the Second Continental Congress here in 1777. Its beautifully restored historic district is an architectural treasure. While York retains its farming and manufacturing heritage, at its heart York is a thriving cultural community that has attracted creative talent and innovative entrepreneurial investors from across the nation.

Life in York County offers affordable housing, options for higher education, a thriving arts and cultural community, historical attractions, parks and recreational resources, semi-professional baseball team, fine dining and more — within an easy drive of major East Coast cities.

York County residents can find local employment in healthcare, manufacturing, technology, agricultural and service sectors. (Patient population: 445,000)

Equal Opportunity Employment

WellSpan Health is an equal opportunity employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color or any other protected class. WellSpan Health does, however, have a tobacco-free/nicotine-free hiring policy.

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