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Full-time (80 hours biweekly)

Weekdays, daytime hours and some evenings

General Summary

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.

Essential Functions:

+ 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.

Common Expectations:

+ Is knowledgeable of and complies with institutional research policies, procedures and guidelines. With the oversight of the Director of Research/Human Subjects Protection Administrator, has knowledge of and complies with governmental regulations regarding responsible conduct of research, research ethics and integrity and protection of the safety and welfare of human subjects (i.e., DHHS, FDA and IRB research regulations, HIPAA privacy and research regulations and others as applicable, such as those governing specimen banks, genetic research, etc.). Instructs less experienced personnel and advises others to insure that research is conducted safely and in compliance with the above. Reports apparent or potential problems to the Director of Research/Human Subject Protection Administrator and the appropriate Service Line Leader.

+ Demonstrates knowledge of the principles of growth and development over the life span of the assigned patient population. Assesses and interprets patient age specific data and provides appropriate, age specific treatment. Provides direct patient care to assigned patient age group(s).

+ Provides outstanding service to all customers; fosters teamwork; and practices fiscal responsibility through improvement and innovation.

+ Attends meetings as required.

Minimum Education:

+ Bachelor's Degree Required

+ Master's Degree Preferred

Work Experience:

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

+ 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

Licenses:

+ Licensed Registered Nurse Upon Hire Required or

+ Registered Nurse Multi State License Upon Hire Required and

+ Heartsaver CPR/AED Upon Hire Required

+ Certified Clinical Research Coordinator Upon Hire Preferred or

+ Certified Clinical Research Professional Upon Hire Preferred

Courses and Training:

+ Appropriate RN specialty certification. Upon Hire Preferred

Benefits Offered:

+ Comprehensive health benefits

+ Flexible spending and health savings accounts

+ Retirement savings plan

+ Paid time off (PTO)

+ Short-term disability

+ Education assistance

+ Financial education and support, including DailyPay

+ Wellness and Wellbeing programs

+ Caregiver support via Wellthy

+ Childcare referral service via Wellthy

For additional details: Benefits & Incentives | WellSpan Careers (joinwellspan.org) (https://www.joinwellspan.org/benefits/)

WellSpan Health's vision is to reimagine healthcare through the delivery of comprehensive, equitable health and wellness solutions throughout our continuum of care. As an integrated delivery system focused on leading in value-based care, we encompass more than 2,300 employed providers, 250 locations, nine award-winning hospitals, home care and a behavioral health organization serving central Pennsylvania and northern Maryland. Our high-performing Medicare Accountable Care Organization (ACO) is the region's largest and one of the best in the nation. With a team 23,000 strong, WellSpan experts provide a range of services, from wellness and employer services solutions to advanced care for complex medical and behavioral conditions. Our clinically integrated network of 3,000 aligned physicians and advanced practice providers is dedicated to providing the highest quality and safety, inspiring our patients and communities to be their healthiest.

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)

WellSpan Health is an Equal Opportunity Employer. It is the policy and intention of the System to maintain consistent and equal treatment toward applicants and employees of all job classifications without regard to age, sex, race, color, religion, sexual orientation, gender identity, transgender status, national origin, ancestry, veteran status, disability, or any other legally protected characteristic.