Clinical Trials Research Nurse Practitioner or Physician Assistant

Bethesda, MD

Want to join a well-established Medical Sciences Team with a large footprint in the Infectious Disease space and make a real difference in the world of clinical research and vaccinations?

Talent Orchard LLC is a boutique woman-owned Workforce Solutions Company and Federal Contractor. We are currently retained by a specialty Government Contractor to assist in finding an experienced Clinical Trials Research Nurse Practitioner or Physician Assistant to support a long-term government customer in Bethesda, MD.

What you will do:

The Clinical Trials Research Nurse Practitioner or Physician Assistant is responsible for:

• Assisting the Principal Investigator and study team in developing clinical protocols.
• Will be responsible for a large regulatory component of natural history and interventional clinical studies, which includes but is not limited to manuscript management, protocol management, safety monitoring reports management as well as adverse events reporting and the documentation related to consent visits.
• Initiating, conducting, managing and overseeing Safety Monitoring visits, remaining updated on adverse events reporting and amend the protocol as needed.
• Managing clinical protocols by assembling and training the study team; overseeing all regulatory compliance to protocols; developing and adhering to relevant SOPs; managing the quality control, completion and submission of study related documentation; preparing, submitting and maintaining IRB, FDA, DSMB, and/or other regulatory documents and research correspondence.
• Monitoring study enrollment goals and initiate strategies to promote enrollment and participant compliance. Coordinating and performing responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits and acquiring patient medical records, obtaining informed consent and overseeing study visits.
• Preparing for and coordinating site visits made by sponsors or study monitors during the course of and at the close of the study.
• Contributing to developing educational materials and educating the community and other research professionals regarding studies and related research issues.
• Mentoring and training new or junior research staff.
• Developing and maintaiing study subject databases; supervise data collection and management including the collection of source documents, using and developing case report forms (CRFs), and ensuring that they are complete and accurate.
• Executing sample collection and initial processing.
• Supervising and coordinating the collection, processing, shipment and storage of biospecimens.
• Managing 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.
   

Your background will include:

• Nurse Practitioners or Physician Assistants with applicable experience and current Licensure and/or Certification to practice as a Licensed NP or PA or RN in the state of Maryland.
• Experience with clinical research study coordination tasks preferred.
• NIH experience desirable but not an absolute requirement.
• Experience using NIH clinical systems desirable but not an absolute requirement.
• Skilled in successful patient recruitment for various clinical studies and trials.
• Excellent interpersonal communication skills.
• Organized and detail oriented.
• Research/clinical background a must.

Established in 2010, Talent Orchard has an exceptional reputation, providing staffing solutions to time-sensitive, talent scarcity issues to deliver better talent management ROI.  Our specialty lies in the critical area of program talent acquisition and resource management, not in one narrow skillset, but across many areas of technical and functional delivery. To learn more about our other exciting opportunities, visit our Jobs Page at www.talentorchard.com.

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