MBR - Charleston, SC | Onsite
WHAT YOU'LL DO
Clinical Research & Study Management
- Coordinate and manage clinical trial activities from participant screening through study completion.
- Review study protocols and ensure all required procedures, assessments, and visits are completed accurately and within established timelines.
- Develop and maintain complete, accurate source documentation in accordance with study protocols and regulatory requirements.
- Support participant recruitment, screening, enrollment, and ongoing study activities.
- Collaborate with investigators, sponsors, clinical research monitors, and internal team members to ensure efficient study execution.
- Ensure clinical trials are conducted in compliance with Good Clinical Practice (GCP), FDA regulations, sponsor requirements, and internal standard operating procedures.
Patient Care & Clinical Responsibilities
- Provide clinical assessments and care to adult study participants within the scope of NP/PA practice and applicable study protocols.
- Perform and/or oversee study-related clinical procedures, including blood draws, ECGs, pulmonary function testing, vital signs, and other protocol-required assessments.
- Review participants' medical histories, medications, laboratory results, and other relevant clinical information.
- Educate participants on study requirements, procedures, medications, and follow-up expectations.
- Recognize and communicate changes in participant health, adverse events, and other clinically significant findings to the appropriate study team members.
- Deliver a professional, compassionate, and supportive experience throughout each participant's clinical trial journey.
Data, Documentation & Quality
- Review and process medical records and clinical research documentation.
- Accurately document study visits, clinical assessments, and relevant findings.
- Enter and maintain study data in sponsor-provided and clinical research systems within required timelines.
- Prepare, process, and coordinate laboratory specimen shipments in accordance with protocol requirements.
- Respond to data queries and support the maintenance of complete, accurate, and inspection-ready study records.
QUALIFICATIONS
- Current Nurse Practitioner (NP) or Physician Assistant (PA) licensure, with the ability to provide care to an adult patient population.
- Master's degree in nursing, physician assistant studies, or a related advanced practice field from an accredited institution, as applicable to the role.
- Previous direct patient care experience required.
- Clinical research experience is highly preferred.
- Strong clinical judgment and demonstrated commitment to patient safety.
- Excellent organizational, documentation, and attention-to-detail skills.
- Ability to interpret and follow detailed clinical trial protocols and regulatory requirements.
- Ability to manage competing priorities and multiple studies in a fast-paced research environment.
- Strong communication and interpersonal skills with a compassionate, patient-centered approach.
Join Monroe Biomedical Research and help shape the future of medicine through exceptional patient care and high-quality clinical research.
