Research Advanced Practitioner (PA-C or ARNP)

CHARLES RIVER CLINICAL SERVICES is looking for a

RESEARCH ADVANCED PRACTITIONER (PA-C or ARNP)

 

BASIC SUMMARY: 

Assist clinical research physicians and/or principal investigators by performing procedures and providing medical assessments, judgments and leadership in support of recruitment, screening and conduct of study, while adhering to professional, regulatory and company standards. Responsible for the welfare, health and safety of subjects.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

· Assist in day-to-day evaluation of subjects to assure safe conduct of study protocol to include initial adverse event evaluation, prescriptive authority.  Participate in and manage adverse events within scope of protocol, GCP and SOPs.

· Perform participant histories and physical exams.

· Understand study background, objectives, design and criteria and have full understanding of/familiarity with the investigational drug.

· Review protocol, informed consent and source documents.

· Prepare documents and train delegated staff on protocol specifics

· Explain study and procedures to facilitate informed consent.

· Witness and document informed consent.

· Attend pre-trial initiation meetings, routine site visits and study close-out meetings with sponsor representatives as requested

· Serve as a liaison to the pharmaceutical sponsor as needed.

· Serve as liaison with the clinical and medical directors to maintain the recruiting process flow, assuring compliance with the protocol.

· Maintain familiarity with emergency equipment (e.g., emergency cart, AED).

· Maintain procedure and equipment cross-training to assist with procedures as needed.

· Review and/or evaluate participant lab work and other participant data.

· Fulfill protocol requirements with respect to presence in clinic for dosing and post-dose patient monitoring.

· Fulfill legal requirements for reporting of medical conditions

· Assist with study specific sponsor and regulatory audits.

· Perform all other related duties as assigned.

 

QUALIFICATIONS:

· Education:  Bachelor’s degree (B.A./B.S.) or equivalent in nursing or related field required.

· Experience:  0 to 3 years directly related experience as an Advanced Nurse Practitioner or Certified Physician Assistant required. Previous experience with conduct of studies in human subjects preferred.

· Certification/Licensure : Must have current licensure in the State of Washington as a Certified Physician Assistant or Nurse Practitioner.  Basic Life Support certification required.   

· Other:  Remain competent in clinical skills and knowledge (i.e., ECG interpretation, IV administration, phlebotomy and laboratory skills, etc.). Must be able to manage medical emergencies. Excellent working knowledge of FDA regulations, GCPs, GLPs, SOPs and Policies.  Solid computer skills, especially word processing and spreadsheets.  Must be able to function independently within a team environment.  Excellent organizational and time-management skills.