[Hiring] Sub Investigator @Worldwide Clinical Trials

Role Description

The Sub Investigator-Nurse Practitioner (NP) or Sub Investigator-Physician’s Assistant (PA) works under legally required physician supervision, performing screening evaluations, medical evaluations, and medical history evaluations of screening volunteers and/or subjects during the course of the study participation.

• Responsible for reviewing and clarifying volunteers’ medical histories and conducting physical exams to determine eligibility for study enrollment according to protocol specifications.
• Medically monitor and assess subjects’ progress during their study participation under medical supervision and direction.
• Accountable for accurately obtaining, preparing, and examining certain laboratory specimens as defined.
• Review and be knowledgeable of assigned clinical trial protocols.
• Attend clinical trial protocol initiation meetings at management’s request.
• Conduct physical examinations and assist in determining volunteers’ eligibility for study enrollment.
• Work with the Medical Director and other medical personnel to ensure the safety of all research participants.
• Obtain and prepare certain laboratory specimens as defined in the study protocol.
• Assess laboratory results and ECG tracings to determine subject eligibility with the Physician Investigator's oversight.
• Monitor and assess the health status and response to treatment of subjects during their course of study participation.
• Evaluate adverse events reported by study subjects and communicate findings to the Principal Investigator.
• Provide medical expertise and support to research staff members for the successful implementation of clinical trials.
• Review screening tools and other study-related documents as requested by research staff.
• Share in the day-to-day training and direction of research staff pertaining to basic research processes.
• Remain knowledgeable of, comply with, and keep Medical Director and Associate Medical Directors informed of State laws and regulations.
• Assist in updating work instructions related to areas of expertise as needed.
• Complete all necessary in-house training, including Standard Operating Procedures (SOPs) and work instructions.
• Assist with Occupational Safety and Health Administration (OSHA) training as requested.
• Assist the Medical Director and other research staff in ensuring NP or PA assessments are reviewed and co-signed by a supervising physician.
• Perform other duties as assigned.

Qualifications

• Acquisition and demonstration of professional medical skills and knowledge for performing accurate patient assessments.
• Excellent attention to detail; ability to interview and communicate effectively with volunteers.
• Ability to perform and record physical exam findings and assessments on volunteers participating in clinical trials.
• High proficiency in identifying, integrating, and documenting abnormal physical findings.
• Excellent verbal and written communication skills and basic computer skills.
• In-depth knowledge of and adherence to medical ethics.
• Compliance with the rules and regulations established by the Texas Board of Nursing.
• Knowledgeable of the clinical research process, including ICH guidelines for Good Clinical Practice.

Requirements

• Bachelor's and Master’s degrees, and completion of an American Medical Association-approved Nurse Practitioner program.
• Current “Nurse Practitioner Permit” (license) through the Texas Board of Nursing.
• Minimum of five (5) years’ experience in clinical practice as a Nurse Practitioner.
• Or Bachelor's and Master’s degrees, and completion of an American Medical Association-approved Physician’s Assistant program.
• Current PA license through the Texas Board of Nursing.
• Minimum of five (5) years’ experience in clinical practice as a Physician’s Assistant.
• Preferred: Two (2) years of clinical research experience.
• Proficiency in women’s health care/exams.

Benefits

• Equal employment opportunities for all employees and applicants.
• Commitment to creating exceptional employee experiences where everyone is respected.
• Focus on attracting diverse talent and cultivating an inclusive environment.