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Job Summary:
The Clinical Research Nurse will work under the supervision of Clinical Research Management and the Principal Investigators (PI). This position will also work in collaboration of physicians, peers and other departments to facilitate the implementation and management of policies and procedures to ensure compliance with regulations and guidelines applicable to research involving human subjects. The Clinical Research Nurse will also assist in planning, monitoring, and assessment of clinical development and operational research projects as assigned. The incumbent in this position will support the mission, vision, values and strategic initiatives of the Mary Washington Healthcare System and must demonstrate a commitment to quality service to patients, physicians, the community and co-workers.
Essential Functions and Responsibilities:
Obtains and reviews medical records for potential research subjects; maintains medical records of research subjects that include documentation of laboratory test results and progress of research study subjects, following guidelines set forth by the protocol sponsors.
Recruits clinical study subjects; schedules appointments and interviews and evaluates potential subjects.
Instructs potential research subjects, responsible family members, and physicians, nurse practitioners, physician assistants, nursing staff, and ancillary staff involved in care of subjects on aspects of the subject’s care, available clinical studies, treatments, and side effects.
Educates subjects concerning diagnosis and treatment plans and explains informed consent procedures, including HIPAA authorizations, to research study subjects and obtain subjects’ written consent. Evaluate and develop subject education materials and give subjects and/or family member’s instruction on drug administration and other medical information.
Performs nursing assessments and monitor subjects' progress during clinical trials and notify principal investigator of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects. Performs an initial interview during each subject visit and plan appropriate care under the direction of a physician, nurse practitioner, or physician assistant.
Coordinates the scheduling of laboratory tests, radiology testing, and/or exams for study subjects. Completes case report forms for each study participant and document medical data in subject study chart.
Performs and/or oversee a variety of clinical duties that may include administration of research study drugs, EKGs, vital signs, physical exams/assessments, processing/shipment of biological specimens, chemistries and recording the results in the subject study chart.
Prepares and/or oversee the preparation of biological specimens for shipment to reference laboratory and centrifugation of hazardous biological and chemical materials. Communicate all lab results to PI, research subjects and medical staff.
Assesses and document compliance of research subjects.
Participates with other research staff in assessing, planning, implementing, and evaluating the success of research studies with other healthcare providers. Coordinates research activities with related medical departments clinic and hospital.
Attends staff meetings/conferences as part of a team of physicians, pharmacies, nurses, other ancillary areas, and research staff.
Discusses current medical treatments, medications, and therapies with medical company representatives and relay this information to medical staff, offering suggestions on the use of new treatments, medications, and therapies.
Acts as principal investigator's representative as appropriate. This may include communicating with private and pharmaceutical company personnel and the clinical research unit.
Maintains subject database information. May assist in preparing for publication. Work with analysts and assist with queries related to data to evaluate the significance of compiled data.
Assists investigators with data collection, review of literature, methodology, and writing of abstracts. Investigates literature for general and specific references of interest to the research protocols and conducts library research as needed. Reviews potential protocols to evaluate their suitability for study.
Develops written informed consent forms for new protocols in accordance with FDA regulations. Prepares project approval forms necessary for submission to appropriate committees.
Assists physician/principal investigator in writing manuscripts for publication and/or presentation of materials at conferences.
Provides orientation, information, training/cross-training, and assistance for new/existing nursing personnel, research assistants, and medical staff to the research activities.
Maintains adequate inventory of research supplies necessary for research activities.
Performs other related duties as assigned.
Qualifications:
Valid RN License from Virginia or reciprocal compact state required.
Graduate of an accredited nursing program, Bachelor's degree in Nursing (BSN) preferred.
2 years previous research experience preferred.
Excellent oral and written communication skills, computer literacy and a proven ability to successfully interact with administration, physicians, patients and Associates.
Ability to interface with the public/community and work effectively with diverse groups and individuals.
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, color, religion, sex, sexual orientation, gender identity, national origin, and veteran or disability status.
