Full-Time Clinical Research Nurse Practitioner/Physician Assistant – Bethesda/Rockville, MD
Job Description
Medical Science & Computing (MSC) is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.
MSC is currently searching for a Clinical Research Nurse Practitioner or Physician Assistant to support the National Institutes of Health (NIH) in the development of malaria vaccines. This opportunity is a permanent, full-time position with MSC and is on-site at the NIH in Bethesda/Rockville, MD.
The primary function of this position is to coordinate and assist in the conducting of phase I clinical trials at the NIH, ensuring that studies are carried out according to protocol, standard operating procedures, and applicable guidelines and regulations.
ESSENTIAL POSITION FUNCTIONS
- Serves as clinical representative in managing protocol execution, with oversight
- Explains research study to participants, including purpose, duration, risks and benefits prior to any study procedures at screening
- Performs clinical study procedures per protocol as required throughout the trial, including physical exams, vital signs, phlebotomy, and electrocardiograms (ECG’s)
- Monitor study enrollment goals and initiate strategies to promote enrollment and participant compliance. Coordinate and perform responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent and overseeing study visits.
- Consents subjects, review medical/surgical history, provide medical assessment & care, perform protocol procedures, prescribe and dispense medications, evaluate and report laboratory findings & adverse events to the Principal Investigator
- Documents adverse events and update source documents based on subject history
- Evaluates and triages subject adverse event assessment; support clinical evaluations as appropriate.
- Ensures that study data collected adheres to study protocol
- Completes case report forms (CRFs) and assist in data query resolution
- Performs drug accountability – receipt, dispensing, return of drug
- Ensures all lab results are reviewed, signed, discussed with participant, and reported to Principal Investigator as appropriate
- Prepares and distributes subject folders including study instructions, study diaries, and related tools
- Has full knowledge of study documents. Assists with drafting of materials.
- Prepare for and coordinate site visits made by sponsors or study monitors during the course of and at the close of the study.
- Develop and maintain study subject databases; supervise data collection and management including the collection of source documents, using and developing CRFs, and ensuring that they are complete and accurate.
- Supervise and coordinate the collection, processing, shipment and storage of bio-specimens.
- Manage close-out of clinical protocols including audit preparation, trial closure, and communication with regulatory agencies, assisting in the final study report and completing financial obligations.
- Assists in developing study budgets, and track budget expenses and billing
- Create monthly and annual reports for open studies as required
- Attends required meetings.
- Performs other duties as assigned
POSITION REQUIREMENTS
- Current Licensure and/or Certification to practice as a Nurse Practitioner or Physician Assistant in the state of Maryland
- Minimum 3 years of clinical trial experience, Phase I trials a plus
- Clinical Research Coordinator experience preferred
- Basic Life Support (BLS) training required, Advanced Cardiac Life Support (ACLS) training preferred
- Knowledge of Good Clinical Practices (GCP) and Health Insurance Portability and Accountability Act (HIPPA) guidelines
- Experience with Malaria research is a plus
- Phlebotomy experience is preferred
- Excellent interpersonal and communication skills
- High attention to detail
- Evening and weekend work may be required
- Interest in global health and/or vaccine research
Medical Science & Computing is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.
