- Location 16200 Addison Rd Suite 155,Addison, TX, 75001,United States
- Employee Type FT Exempt
Clinical Research Physician Assistant / Nurse Practitioner (PA-C / NP)
Company: CareOn Research Position Type: Full-Time
Position Summary
CareOn Research is seeking an experienced and highly motivated Physician Assistant (PA-C) or Nurse Practitioner (NP) to support our Principal Investigators and clinical research team in the conduct of Phase II–IV clinical trials.
This position will serve as a key clinical resource within our research program, working closely with Principal Investigators, Sub-Investigators, Clinical Research Coordinators, and other research personnel to provide appropriate medical oversight and perform protocol-required clinical activities.
The ideal candidate is comfortable working independently within their delegated scope, managing research participants, performing physical examinations and clinical assessments, reviewing laboratory and diagnostic results, evaluating adverse events, and maintaining accurate, inspection-ready clinical documentation.
The PA/NP will help ensure that clinical trials are conducted safely, efficiently, and in accordance with study protocols, Good Clinical Practice (GCP), FDA regulations, sponsor requirements, and CareOn Research standards.
Key Responsibilities
- Support Principal Investigators and Sub-Investigators in the day-to-day clinical conduct of research studies.
- Perform protocol-required physical examinations, medical assessments, and clinical evaluations of research participants.
- Obtain and review medical histories, medication histories, and relevant clinical information.
- Review vital signs, laboratory results, ECGs, diagnostic testing, and other study-related clinical data as appropriate.
- Assess participants for potential adverse events (AEs), serious adverse events (SAEs), and changes in clinical status , with appropriate PI involvement and escalation.
- Assist investigators with evaluation of participant eligibility based on protocol inclusion and exclusion criteria.
- Conduct study visits and protocol-required assessments as delegated by the Principal Investigator.
- Evaluate participants throughout the study for changes in health status and potential safety concerns.
- Provide appropriate clinical follow‑up and patient education.
- Perform clinical procedures within professional licensure, training, study requirements, and delegated authority.
- Complete accurate and timely source documentation in paper and/or electronic source systems.
- Ensure clinical documentation supports ALCOA+ principles and is suitable for sponsor, CRO, regulatory, and FDA review.
- Review and electronically or physically sign clinical documentation when appropriate and delegated.
- Respond to clinical questions from research coordinators and provide timely medical guidance within scope.
- Work closely with Clinical Research Coordinators to ensure study visits are completed according to protocol.
- Communicate clinically significant findings promptly to the Principal Investigator.
- Participate in investigator meetings, Site Initiation Visits, monitoring visits, sponsor meetings, and other study‑related meetings as needed.
- Assist with sponsor and CRO questions related to participant safety and clinical assessments.
- Support timely resolution of clinical data queries and documentation discrepancies.
- Maintain required study‑specific training, GCP training, professional licensure, and applicable certifications.
- Follow all applicable FDA regulations, ICH‑GCP guidelines, institutional policies, research SOPs, and study protocols.
- Assist /*is missing? Actually they continue*/ with clinical research activities across CareOn Research locations when needed.
- Help support the continued expansion of CareOn Research’s clinical trial portfolio and investigator network.
Qualifications
Required
- Current and unrestricted Physician Assistant or Nurse Practitioner license .
- PA candidates must maintain appropriate NCCPA certification, as applicable.
- NP candidates must maintain appropriate national board certification.
- Current BLS certification; ACLS preferred where applicable.
- Graduate of an accredited Physician Assistant or Nurse Practitioner program.
- Ability to independently perform comprehensive patient assessments and physical examinations within scope of practice.
- Strong clinical judgment and ability to recognize and appropriately escal...
- Excellent written and verbal communication skills.
- Strong documentation skills and attention to detail.
- Ability to work collaboratively with physicians, research coordinators, sponsors, CROs, and other healthcare professionals.
- Ability to manage multiple studies and competing clinical priorities.
Preferred
- Previous clinical research experience.
- Experience working as a Sub-Investigator or supporting Principal Investigators in clinical trials.
- Knowledge of ICH‑GCP, FDA regulations, and clinical research documentation requirements .
- Experience with Phase II, III, or IV pharmaceutical or biotechnology clinical trials.
- Experience with eSource, EDC, CTMS, or other clinical research technology platforms.
- Experience in specialties such as pulmonology, internal medicine, cardiology, neurology, or other areas relevant to CareOn Research’s clinical trial portfolio.
Clinical research experience is strongly preferred but is not required for an otherwise strong clinical candidate who is interested in transitioning into research and willing to complete comprehensive research training.
Ideal Candidate
The ideal candidate is a clinically strong PA or NP who enjoys working closely with physicians while also having a high degree of autonomy and responsibility. This individual should be comfortable interacting with research participants, identifying clinical concerns, working within detailed study protocols, and maintaining exceptionally accurate documentation.
This is an excellent opportunity for an advanced practice provider who wants to build expertise in the pharmaceutical and clinical research industry while playing an important role in bringing new investigational therapies to patients.
Compensation
Final compensation will be based on clinical experience, research experience, specialty background, credentials, and overall qualifications.
This is a full‑time clinical research position requiring regular interaction with research participants, Principal Investigators, Sub-Investigators, Clinical Research Coordinators, sponsors, CROs, and other members of the CareOn Research team.
Some travel between CareOn Research clinical locations and attendance at investigator or sponsor meetings may be required.
About CareOn Research
CareOn Research is a growing clinical research organization focused on delivering high-quality clinical trials through experienced investigators, dedicated research personnel, strong patient recruitment capabilities, and technology-enabled clinical operations.
Our team works with pharmaceutical companies, biotechnology companies, and CRO partners to conduct clinical trials while maintaining a strong focus on participant safety, data quality, regulatory compliance, and operati onal excellence.
Role Overview
CareOn Research is seeking