Job Summary
We are seeking a dedicated and skilled Physician Assistant to join a clinical research team. This role is responsible for overseeing, supporting, and executing clinical trials while ensuring compliance with all regulatory and institutional guidelines. This position involves clinical care responsibilities, medical assessments, subject safety oversight, and protocol adherence. The professional in this role acts as both a clinical leader and coordinator, working directly with study participants, investigators, sponsors, and research staff to ensure the success of clinical research projects and delivery of high-quality care.
Duties & Responsibilities
- Coordinate the initiation, execution, and close-out of clinical trials, ensuring that all activities are conducted in accordance with Good Clinical Practice (GCP), study protocols, FDA regulations, and IRB guidelines.
- Ensure protocol compliance, maintain regulatory documentation, and support the conduct of audits.
- Track enrollment, manage visit schedules, and maintain accurate study records and logs.
- Identify protocol deviations and collaborate in implementing corrective actions.
- Participate in investigator meetings and site initiation visits.
- Perform and document medical histories, physical exams, and study-related clinical procedures.
- Assess patient eligibility and obtain informed consent in compliance with IRB and GCP guidelines.
- Monitor adverse events and report findings to the appropriate regulatory entities.
- Collaborate with Principal Investigator in safety monitoring and dose modifications.
- Support the Principal Investigator in conducting the clinical study.
- Evaluate and sign off on clinical assessments, lab results, and protocol-mandated decisions.
- Participate in clinical decision-making regarding subject care and investigational products.
- Document clinical findings in source documentation and CRFs.
- Ensure all subject data is collected and entered accurately and in a timely manner.
- Collect and process biological specimens per protocol requirements.
- Operate and maintain research-specific equipment.
- Provide patient education on study medications and procedures.
- Assist with site training, staff supervision, and continuous quality improvement initiatives.
- Complete regulatory submissions, adverse event reports, and study progress reports.
- Use electronic data capture (EDC) and ePRO systems to record and manage data.
- Support with compensation processing and other administrative tasks related to research.
- Perform or supervise study-specific medical procedures including vital signs, EKGs, sample collections, drug administration, and protocol-specific assessments.
- Assist in the creation and revision of SOPs, informed consent templates, and site-specific forms.
Education & Experience
- Degree as Physician Assistant, Nursing, or related field.
- Active professional license (e.g., PA-C, NP, or equivalent).
- Certification in Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS).
- At least 5 years of experience in clinical research, patient care, or healthcare setting.
- Prior MD studies and Sub-Investigator experience preferred.
- Knowledge of anatomy, physiology, medical terminology, and diagnostic evaluation methods is essential. This position requires a commitment to providing exceptional patient care while maintaining the highest standards of professionalism within the healthcare environment.
Skills & Competencies
- Strong clinical judgment and ethical decision-making.
- High level of organization and attention to detail.
- Excellent written and verbal communication skills in both English and Spanish.
- Proficient in medical documentation and use of electronic systems.
- Team leadership and ability to train staff.
- Knowledge of FDA regulations, GCP, ICH guidelines, and IRB procedures.
Sapphire HR Innovations is an Equal Opportunity Employer. We do not discriminate against any individual based on race, color, ethnicity, national origin, sex, sexual orientation, disability, mental condition, social or political status, religion, military or veteran status, age, protective hairstyles and/or hair texture, in accordance with applicable laws and regulations.
Job Type: Full-time
Pay: $35.00 - $45.00 per hour
Expected hours: 40 per week
Benefits:
- Flexible schedule
- Health insurance
Work Location: In person