Nurse Practitioner or Physician Assistant (Sub Investigator) - Part-time
M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US.
Due to our continued growth, we are hiring for a Sub-Investigator at Wake Research, an M3 company. This position is on-site and located in Dallas, TX. This is a part-time position.
The Sub-Investigator provides oversight in medical and clinical issues, as requested or required. The Sub-Investigator works with the Principal Investigator (PI) to evaluate clinical trials and ensure that all study-related procedures are completed in accordance with Good Clinical Practices (GCP). The Sub-Investigator performs critical trial-related procedures and makes important trial-related decisions when delegated by the PI to do so. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study participants according to protocols, and for protecting the health, safety, and welfare of research participants.
Essential Duties and Responsibilities:
- Provides participant consultations and education in an in- or out-patient setting under the direction of the PI in charge of the clinical trial.
- Conducts study-related physical exams and follow-up visits.
- Reviews and adheres to assigned research study protocols.
- Works with the study-leading PI in evaluation and review of potential study participant eligibility.
- Maintains proper documentation in accordance with GCP.
- Ensures that all clinical activities are carried out in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
- Collaborates with multidisciplinary team members.
- Reviews lab results, imaging reports, and other study-specific reports.
- Reviews and verifies participant medical history collected by the Wake Research Staff/Clinicians.
- Communicates with the participant as well as the participant’s partner/informant/caregiver.
- Attend and successfully complete all training programs in a timely manner.
- Attend, participate in, and complete ongoing conference calls, webinars, required meetings, and other professional development opportunities.
- Complete provided rater training, Good Clinical Practice (GCP) training, and any Sponsor required trainings.
- Conduct participant interviews following specific study protocols, FDA, GCP, ICH, and HIPAA Privacy guidelines.
- Maintains knowledge and education of all applicable rules, regulations, policies, laws and guidelines respective to their field and role.
- Support site operations for community outreach and recruiting efforts.
Requirements:
- Master’s Degree required.
- Licensed Advanced Practice Registered Nurse (APRN) successful completion of an accredited program OR Physician Assistant (PA-C) successful completion of an accredited Physician Assistant Program.
- Current license to practice in the state of hire.
- No history of license suspension or debarment in any state or by the FDA.
- Must have BLS and ACLS certifications; PALS required if pediatric experience needed at site.
- Trained in phlebotomy, additional pediatric experience preferred.
- Experience in bedside procedures is preferred.
- 2 years of clinical practice experience is required.
- 2 years of clinical research experience as a sub-investigator is preferred.
All your information will be kept confidential according to EEO guidelines.
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