Sub- Investigator Position DescriptionPosition OverviewThe Sub Investigator is responsible for conducting clinical trials in accordance with the research protocol, Good Clinical Practices (GCP), and federal/state regulations. The Sub Investigator will collaborate with the study team, as well as various medical pharmaceutical companies, and regulatory personnel to ensure the health and welfare of study subjects under the direction of the Principal Investigator.
The Sub Investigator reports to the Principal Investigator.
Classification: Exempt
Primary Responsibilities:- Maintain a current license to practice medicine.
- Assume responsibility as the Sub Investigator for the duration of the clinical trials.
- Conduct testing and rating scales per sponsors instructions and protocols.
- Completion of documentation, paper and electronic as required per protocol.
- Provide detailed study related documentation as required and ensure data integrity.
- Perform evaluations on subjects as needed per the protocol.
- Perform physicals per study protocol, as needed.
- Perform and review ratings performed by outside physicians, as needed in accordance with the study protocol.
- Evaluate subjects for clinical research trials based on their past medical and psychiatric history compared to inclusion and exclusions per study protocol.
- Evaluate subject safety and compliance with investigational product as specified by protocol.
- Evaluate and report all serious adverse events (SAEs) during the trial.
- Assess and rate severity of AEs during the conduct of the protocol as delegated.
- Primary Investigator responsibility in PIs absence, as delegated.
- Educate study team on patient population and mechanism of action of the study medication / device.
- Adhere to requirements on the FDA1572, Statement of Investigator form.
- Collaborate with site leadership to ensure operational goals are met.
- Possess through understanding of clinical research protocols and patient populations for each clinical research trial.
- Develop and maintain strong working knowledge of regulatory requirements and GCP standards.
- Ensure appropriate delegation and training of the Clinical team.
- Complete training as required per sponsor's vendors to obtain certification to conduct testing and rating scales for specific protocols.
- Attend Investigator meetings and educational seminars.
- Other duties as assigned
Desired Skills and Qualifications: - At least 3 years experience conducting clinical research trials as either PI or Sub-I.
- Possess and maintain a valid MD or DO medical license, PA, or NP license.
- Active license to practice medicine within the state.
- Understanding of FDA regulations, ICH guidelines, and Good Clinical Practices.
- Exercise Standard Universal Precautions
- Demonstrate strong leadership skills.
- Excellent task management and prioritization skills.
- Strong verbal and written skills
- Great interpersonal skills
- Keen and acute attention to detail
- Ability to work independently and demonstrate initiative.
- Positive, collaborative, and team oriented.
- Ability to work in a fast-paced environment, adapt, and ability to multi-task.
- Excellent follow-up skills.
- Fluent in English.
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.
