JOB OVERVIEW: This position is responsible for the operations of the Research department, research staff and maintaining research protocols at Valley Medical Center. This includes management of departmental budgets, day to day operations, nursing care and assessment for patients enrolled in research studies, patient care, coordination with Principle Investigators for individual studies, maintaining complete and comprehensive records for the research operation, and environmental and organizational tasks.
ROLE: Exempt - Professional level
AREA OF ASSIGNMENT: Clinical Support
RESPONSIBLE TO: Vice President Ambulatory Services
Current Washington State RN licensure is required.
Bachelor degree required, Master’s degree preferred.
10 years nursing experience required.
Minimum of five years’ research experience including multiple modalities.
Minimum of three years’ management experience required.
ACRP or SOCRA certification preferred.
Ability to comprehend, execute and act within scope of practice.
Ability to communicate effectively in oral and written form in the English language.
Demonstrates effective interpersonal skills in a diverse population.
Able to deal with a variety of personnel, financial and non-financial, management and staff.
Excellent communication skills including ability to relate well with a variety of people and to sustain an attitude of respect for all individuals.
Commitment to team problem solving approach using a research and patient-focused model.
Ability to multi-task in a fast-paced environment and prioritize.
Organizational skills both to function independently and as a member of the professional team.
Judgment skills as reflected in the making of appropriate decisions with consistency.
UNIQUE PHYSICAL/MENTAL DEMANDS, ENVIRONMENT, AND WORKING CONDITIONS: Requires prolonged sitting, some bending, stooping and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, copier, telephone, calculator and other office equipment. Requires ability to deal with stressful situations and multiple deadlines. Requires normal range of hearing and eyesight.
Generic Job Functions: See Generic Criteria for Administrative Partner.
Unique Job Functions:
Maintaining the regulatory, clinical and administrative aspects of several clinical trials at a time.
Accesses appropriate training as needed to complete assigned studies.
Monitor, maintain, research study source documents for research study sponsors.
Monitors study subject compliance.
Monitors study coordinators for GCP compliance and adherence to protocols.
Reports study department progress and problems to VP Ambulatory Services.
Maintaining budget for department and all studies.
Responsible for hiring, performance reviews, continuing education, disciplinary actions and terminations as necessary.
Oversees assignment and work schedules, acts upon leave requests, conducts annual performance evaluations, and disciplinary action.
Provide administrative direction and evaluation of all the program activities.
Meet with research staff to provide direction concerning the management of patients in the program.
Intervene with staff for problem solving in case management, service priority and conflict resolution.
Consult with the program leadership in developing quality indicators and evaluation for performance and processes within their assignment.
Provide leadership in establishing a customer-focused service consistent with the Medical Center’s initiatives and plan.
Serve as a role model in setting a standard of practice within VMC and in meeting all obligations of management, including timely completion of reports and adherence to budgetary targets.
Consult with VMC medical and administrative leadership to assist in recruiting staff members to the program whenever necessary.
Consult and participate actively in Joint Commission and other accrediting bodies’ compliance efforts.
Work with management, staff and physicians to facilitate cost-efficient usage and an extraordinary “user-friendly” environment.
Oversee scheduling, turnarounds, communication, reporting, personnel, supplies, and equipment, to improve operational efficiencies.
Preparation of study startup materials.
Scheduling, preparing for and participating in monitoring visit from sponsor.
Addressing issues noted by monitors.
Assuring compliance with FDA/GCP guidelines.
Conducting research visits including obtaining informed consent.
Nursing Assessment when needed.
Obtaining and Monitoring Vital Signs.
Medication dispensing and tracking.
Concomitant medications recording.
Monitoring and assessing subjects for Adverse Events.
Notification of problems to Principal Investigator.
Conducting research meetings.
Advising and reporting research department budget and status.
Analysis of patients to identify potential subjects.
Scheduling research visit and research procedure appointments.
Maintain knowledge of protocols and subsequent amendments.
Keeping Principal Investigators and Sub investigators apprised of study requirements and subject process.
Interfacing with Sponsor/IRB/CRO.
Day to day oversight of multiple studies.
Structuring training and monitoring of staff qualifications.
Performs other related job duties as required.