Summary:The Sub Investigator (NP or PA-C) plays a critical role in supporting clinical research studies within the healthcare sector. This position involves collaborating closely with the Principal Investigator to ensure the integrity and compliance of clinical trials, while providing expert patient care and assessment. The Sub Investigator will be responsible for conducting patient evaluations, managing study protocols, and ensuring accurate data collection in accordance with regulatory standards. This role demands a thorough understanding of clinical research methodologies and the ability to apply advanced clinical knowledge to support study objectives. Ultimately, the Sub Investigator contributes to advancing medical knowledge and improving patient outcomes through rigorous and ethical research practices.
Essential Duties and Responsibilities:- Assist the Principal Investigator in the design, implementation, and management of clinical research protocols.
- Conduct patient assessments, including medical history reviews, physical examinations, and monitoring of adverse events.
- Ensure compliance with all regulatory requirements, institutional policies, and Good Clinical Practice (GCP) guidelines.
- Collect, document, and maintain accurate and timely clinical trial data and source documentation.
- Collaborate with multidisciplinary teams including research coordinators, sponsors, and regulatory bodies to facilitate smooth study operations.
- Educate and communicate with study participants regarding study procedures, risks, and benefits to ensure informed consent.
- Monitor patient safety and report any safety concerns or protocol deviations promptly.
- Participate in investigator meetings, training sessions, and continuous education to stay current with clinical research standards.
- Perform other duties as assigned.
Qualifications:- Experience working in clinical research or healthcare settings with direct patient care responsibilities.
- Comprehensive knowledge of clinical trial processes, regulatory requirements, and ethical standards.
- Strong understanding of medical terminology, clinical procedures, and patient assessment techniques.
- Previous experience as a Sub Investigator or Clinical Research Coordinator in a healthcare research environment, preferred.
- Familiarity with electronic data capture (EDC) systems and clinical trial management software, preferred.
- Experience working with diverse patient populations and complex clinical trial protocols, preferred.
- Strong background in a specialized therapeutic area relevant to ongoing clinical studies, preferred.
Certificates, Licenses, and Registrations:- Current and valid Nurse Practitioner (NP) or Physician Assistant-Certified (PA-C) licensure in the United States.
- Ability to obtain and maintain necessary certifications such as Good Clinical Practice (GCP) training.
- Advanced certifications related to clinical research, such as Certified Clinical Research Professional (CCRP), preferred.
ACN does not provide visa sponsorship for this role. Candidates who will require immigration or visa sponsorship at any time now or in the future (including, but not limited to, H-1B, TN, or STEM OPT training plans) are not eligible for this role.
