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Clinical Research Nurse Practitioner/Physician Assistant
1 month ago
Location: Orange, CA
Job Type: Temp to Perm
Pay: $140K-$150K/year
Smarter HR Solutions LLC is seeking a highly skilled Clinical Research Nurse Practitioner/Physician Assistant to join our team. As a key member of our clinical research team, you will be responsible for ensuring that studies are implemented in full compliance with FDA Regulations and Guidelines, Good Clinical Practices (GCP), and the research clinic.
Responsibilities
Key Responsibilities:
• Collaborate closely with Principal Investigator (PI) and clinical research team to ensure compliance with regulatory requirements.
• Ensure that studies are implemented in full compliance with FDA Regulations and Guidelines, Good Clinical Practices (GCP), and the research clinic.
• Maintain study files and provide copies of forms to study sponsor, IRB, general clinical research center, and FDA, including reporting of SAEs and AEs per regulatory and institutional guidelines.
• Provide direct care using the nursing or medical process in support of clinical research trials.
• Assist in the design of recruitment strategies.
• Recruit participants according to IRB-approved methodologies.
• Coordinate visits, schedule participant visits with support services, and perform interviews and clinical assessments to collect data required by the protocol.
• Attend and participate in investigator meetings and calls with the sponsors.
• Conduct original research on applicable medical/nursing related topics and disseminate the findings via presentations at professional meetings and peer-reviewed publications.
• Order and receive drug/device supplies.
• Oversee proper documentation of close-out as required by grant sponsors, including the return of unused supplies, reconciliation of test/drug accountability forms, study summary, evaluation of team effort, and subject enrollment.
• Work involves organizing and executing all phases of clinical protocols.
• Ensure appropriate and accurate documentation of patient care in the medical record and designated electronic case report forms and specific computer programs.
• Advise, perform, and instruct staff, research participants, and/or others about protocol-specific procedures and treatments, equipment, policies, adverse medication reactions, and follow-up instructions appropriate to the research study.
• Perform and/or assist in participants' briefings and screenings, including obtaining informed consent.
Requirements
Qualifications:
• Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in nursing from an accredited nursing program or completion of an accredited Physician Assistant program.
• Bachelor's degree in nursing AND current RN or PA licensure in the state of California (full licensure preferred).
• Must possess basic skills in clinical nursing, including drawing blood with butterfly needles and IV catheters.
• Must possess and maintain certification to conduct human research, such as HIPAA and CITI training.
• Based on guidance from the Lead Principal Investigator and Site Principal Investigator, will update research investigators on relevant issues, concerns, and progress of study.
• Must have applicable current licenses/certifications and no negative marks against Nurse or PA license.
Desired skills include:
• Clinical research
• Dosage ranges
• Indications
• Ethical Research Principles & Practices
• Side effects
• Keen attention to detail
• Medical terminology
• Microsoft Office proficiency
Licensing or Certifications:
List any licenses or certifications required by the position: (Registered Nurse for Clinical Nurse Practitioner, Licensed PA for Physician Assistant) ACLS, BLS, ACRP, OCN, ONS, CPR, CCRP, CCRC, AHA, BLCS
