Research Coordinator Institute RN

Conducts professional nursing research and study services (in a variety of inpatient and/or outpatient settings) in support of specified pharmaceutical or medical device research programs, and for ensuring that all clinical activities are carried out in accordance with the established protocol and within acceptable clinical procedural and safety standards. Work includes planning and executing procedures for screening, enrolling, monitoring and retaining clinical research patients and/or volunteers in accordance with established study protocol(s) and FDA (Federal Drug Administration) guidelines for clinical trials, research study management and monitoring.

Work is performed under rigorous conditions relating to the accuracy of study data, and is subject to frequent audits to validate that the information on CRF (Case Report Form) and other source documents are consistent and correct. An incumbent must be fully conversant with nursing practices sufficient to elicit timely and accurate information with respect to side effects experienced by study/protocol participants, and to take appropriate action within the defined scope of responsibility.

Essential Functions Include:

Determines patient eligibility for participation in drug and/or medical device research studies/protocols, ensuring the rights, safety and welfare of patients at all times.

Screens patients in timely and accurate manner using protocol-specific inclusion and exclusion criteria.

Explains the purpose, risks and benefits of clinical trial participation.

Ensures that study patients understand the information presented and agree to the conditions; obtains a signed consent form prior to any study-related procedure being performed.

Provides instructions to patients to ensure proper protocol compliance.

Analyzes established protocol(s) guidelines to understand, interpret and implement provisions, assessments and requirements and to ensure that proper protocol procedures and medication administration are followed and executed accordingly.

Plans, schedules and documents day-to-day clinical activities and procedures, ensuring efficient workflow and adequate care and treatment of research patients; coordinates and monitors the collection, processing and recording of clinical data and/or specimen samples, as required by the study protocol.

Performs EKG and phlebotomy; monitors vital signs and/or performs other specialized nursing procedures as appropriate to the specific requirements of the study and the needs of the individual patients; may administer prescribed study medications, assess IVs and/or conduct patient physicals if allowed under the study protocol.

Schedules, conducts and documents follow-up visits (in person or via telephone) as outlined in the study protocol; coordinates follow-up visits to correspond to other scheduled appointments to facilitate patient convenience; follows up with patients between scheduled visits to identify side effects, medical events or hospitalizations, and advises Investigator, sponsor and MREC as necessary.

Provides subject care according to protocol and in accordance with established regulations and guidelines (ie. FDA, GCP/ICH).

Performs, or makes arrangements for, all study procedures and assessments.

Works with Research pharmacy staff to ensure proper preparation, timing and administration of study medication.

Participates in budget administration and feasibility assessments with respect to new/current clinical trials; assists management in goal setting and formulation/implementation of action plans for the Research department.

Works collaboratively with study sponsors (drug companies), and prepares/provides accurate, timely and complete documentation.

Acts as liaison to ensure complete and accurate communication between sponsor, investigators and other research staff and patients.

Creates appropriate source documents or uses sponsor-provided source documents; obtains protocol-specific data to complete and maintain source document(s) and case report form(s) (CRF) in accordance with applicable regulations, guidelines and sponsor requirements.

Monitors and records patient response to treatment, and communicates study data and results to investigators; maintains complete source documentation and oversees the preparation of study activity reports for sponsors and various medical, legal and regulatory bodies as appropriate.

Provides FHS MREC with timely, accurate and complete information in accordance with established procedures, FDA regulations and GCP guidelines; identifies and notifies MREC of adverse events and protocol deviations; submits annual reports for each assigned protocol on a timely basis.

Serves as point-person for routine monitoring visits and external audits of assigned studies as conducted by sponsors, the FDA and/or other entities.

Meets with auditors, clarifies and researches information, reviews findings and takes corrective action as necessary.

Participates in department operations to include coordinating protocol-specific meetings, communications and needed services for other FHS departments.

Coordinates protocol-specific intra- and inter-departmental scheduling and communication activities.

Schedules site initiation meetings with management.

Provides in-service education on protocols to physicians’ offices, Research Center staff and/or other departments.

Coordinates assistance needed from other FHS departments (i.e. Patient Care areas, Laboratory, Business Office).

Cultural Sensitivity and Competence: Demonstrates proper use of communication tools/materials for effective communication and understands how the culture(s) of patient populations can affect communication, collaboration and the provision of care, treatment and services. Patient Population Served: Demonstrates knowledge and proper skills associated with the department’s defined specific populations served.

Employees may be required to perform other duties as assigned.

Education / Experience:

• Associate's degree in Nursing
• 3+ years of recent closely related work experience that demonstrates the attainment of the requisite job knowledge, skills and abilities.

Certifications:

• Active Washington State Registered Nurse License
• Basic Life Support - CPR (BLS-CPR)

Virginia Mason Franciscan Health has a rich history of providing exceptional healthcare, dating back to 1891. Building upon a legacy of compassionate care and innovation, our organization has evolved over the years through strategic partnerships and integrations to expand our reach and services across the Puget Sound area.

Today, as Virginia Mason Franciscan Health, we remain deeply committed to healing the whole person – body, mind, and spirit – in the communities we serve. This commitment is strengthened by the diverse expertise and shared values brought together through our growth.

Our dedicated providers offer a full spectrum of health care services, from routine wellness to complex disease management, all grounded in rigorous research and education. Our comprehensive network of 10 hospitals and nearly 300 care sites strategically located across the greater Puget Sound region reflects our ongoing commitment to accessibility and comprehensive care.

We are proud of our pioneering medical advances and numerous awards and accreditations that reflect our dedication to excellence. When you join Virginia Mason Franciscan Health, you become part of a team that delivers top-quality, professional healthcare in modern, well-equipped facilities, and contributes to a legacy of service built on collaboration and shared purpose.