A Clinical Investigator works on a clinical trial, and is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The Clinical Investigator must also meet requirements set forth by the FDA, EMA or other regulatory body. The qualifications must be outlined in a current resume and readily available for auditors.
Sub Investigator - Part Time Helios Clinical Research - 3.3 Fort Lauderdale, FL Job Details Part-time 1 day ago Qualifications Patient care Advanced practice provider
Full Job Description Job Title :
Part-Time Sub-Investigator FLSA Classification:
Non Exempt Reports to: Principal Investigator /
Project Director Job Summary/ Objective:
The Part-Time Sub-Investigator supports the Principal Investigator (PI) in the conduct of clinical research by performing delegated medical and study-related responsibilities in accordance with study protocols, sponsor requirements, Good Clinical Practice (GCP), applicable regulations, and Helios Clinical Research policies and procedures. This role is responsible for protecting the rights, safety, and welfare of research participants and supporting the accuracy and integrity of clinical trial data within the scope of delegated duties.
Essential Functions:
Complete required sponsor, protocol, GCP, and internal training within required timelines and maintain current professional licensure and credentials. Maintain a thorough working knowledge of assigned study protocols and perform only those study duties for which appropriately qualified, trained, and delegated by the PI. Assess potential participant eligibility, including review of medical history, inclusion/exclusion criteria, laboratory results, diagnostic testing, and other clinical information as required by protocol. Conduct protocol-required medical assessments, including physical examinations and other clinical evaluations within scope of practice and delegation. Review and interpret laboratory results, ECGs/EKGs, diagnostic reports, concomitant medications, and other safety data as required by protocol. Evaluate participants for adverse events and changes in clinical status; ensure appropriate medical care is provided and promptly communicate safety concerns, including serious adverse events, to the PI and research team. Support the informed consent process as delegated, including answering participant questions and confirming medical appropriateness for study participation. Assess participant response to study treatment/intervention and compliance with protocol requirements throughout study participation. Complete and sign study source documentation and other required records accurately, completely, and within required timelines. Collaborate with the PI, clinical research coordinators, sponsors, monitors, medical monitors, and other study personnel regarding participant eligibility, safety, protocol compliance, and study conduct. Participate in sponsor meetings, monitoring visits, audits, inspections, and study-related meetings as needed. Identify and communicate protocol deviations, safety concerns, or other issues that may affect participant welfare, protocol compliance, or data integrity. Maintain participant confidentiality and comply with
GCP, FDA
regulations, informed consent requirements, HIPAA, and applicable ethical standards. Perform other study-related duties as assigned and appropriately delegated.
Education/Experience/Skills:
Current, unrestricted professional license in the state in which services are performed as a physician (MD/DO), nurse practitioner (NP/APRN), or physician assistant/associate (PA), as applicable to the assigned study and permitted by protocol, sponsor, and regulatory requirements. Graduate of an accredited professional program appropriate to licensure; board certification or specialty training may be required based on study needs. Clinical experience sufficient to safely evaluate and manage the patient population supported by assigned trials; oncology experience preferred. Clinical research experience preferred; prior Sub-Investigator experience strongly preferred. Knowledge of Good Clinical Practice (GCP), FDA regulations, clinical research documentation requirements, and participant safety responsibilities. Ability to complete sponsor-specific training and qualification requirements for assigned protocols.
Knowledge/Skills/Abilities:
Strong clinical judgment and ability to recognize and appropriately respond to changes in participant condition. Excellent organizational skills with exceptional attention to detail and documentation accuracy. Excellent interpersonal, oral, and written communication skills. Ability to work collaboratively with investigators, research staff, participants, sponsors, and external partners. Must be self-directed, dependable, and able to prioritize responsibilities within required study timelines. Ability to maintain flexibility in schedule based on study enrollment, participant visits, and protocol needs. Proficiency with electronic medical records, clinical trial systems, and Microsoft Office applications as required.
Working Conditions/ Physical Demands:
This is a part-time, as-needed position scheduled based on study and participant needs. Work is primarily performed in a clinical research and medical office environment and may include exposure to bloodborne pathogens and biohazardous materials. The role requires prolonged walking and standing, as well as some bending, stooping, and stretching. It requires hand-eye coordination and manual dexterity sufficient to operate standard clinical and office equipment, and normal range of hearing and eyesight to assess participants, review clinical information, and communicate appropriately. Schedule flexibility may be required to support participant visits and study-related activities.
Travel required:
As needed for investigator meetings, training, or other study-related activities. Disclaimer This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.
