The Nurse Practitioner/Physician Assistant (Sub-Investigator) plays a key role in maintaining the integrity and quality of clinical trials by ensuring compliance with federal, state, and local regulations, IRB requirements, and OMRC policies. In collaboration with the Principal Investigator (PI) or Medical Director, this position is responsible for accurately performing study visit procedures and collecting patient data in accordance with study protocols, while safeguarding the health, safety, and well-being of research participants. The NP/PA Sub-Investigator may also support select studies in a limited capacity as a Study Coordinator.
Essential Duties and Responsibilities:
- Reviews, comprehends, and adheres to assigned study protocol.
- Assists trial Investigators in screening and review of potential study participants' eligibility.
- Conducts subject visits.
- Maintains case report forms, patient charts and documentation.
- Ensures that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
- Collects and enters data as necessary.
- Reviews lab results, imaging reports, and other study-specific reports.
- Completes required protocol training
Requirements:
- Master’s Degree required
- Licensed Nurse Practitioner/Physician Assistant
- At least 2 years of clinical research or sub-investigator experience is ideal, but not required
- Current Advanced Cardiovascular Life Support (ACLS) certification
- Phlebotomy training required
- IV and infusion experience preferred
- Sound knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs
- Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills
- Strong written and verbal communication skills
- Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams
- Strong computer skills in appropriate software and related company clinical systems is required
About M3:
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
*M3 reserves the right to change this job description to meet the business needs of the organization
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