Job Description

Summary:

The Sub-Investigator (Sub-I) plays a critical role in clinical research by supporting the Principal Investigator (PI) in conducting clinical trials. This is a part-time position (8–10 hours per week) and offers an excellent opportunity for professional growth, with potential to advance into a Principal Investigator (PI) role.

Duties and Responsibilities: The Sub-Investigator:

• Attends Site Initiation Visits and/or training in-service for all current protocols.
• Completes required SOP training.
• Performs study tasks delegated by the Principal Investigator (PI) with full involvement and oversight in accordance with protocol and regulatory requirements.
• Provides guidance to the clinical team as needed.
• Assists in the training of support staff for the clinical trials under supervision.
• Assists in recruitment for clinical trials; refer to other site trials.
• Sets schedule to accommodate patients onsite and/or offsite as necessary. This may include weekends and holidays.
• Conducts proper informed consent process according to SOPs, ensuring the most current ICF version is used.
• Evaluates the eligibility of patients for inclusion into clinical trials.
• Collects medical and surgical history, concomitant medication use, and adverse event information.
• Documents source documents, inpatient activities, visit progress notes, and adverse events. Maintains accurate records throughout the study.
• Reviews lab results, provides clinical significance for any out-of-range or abnormal values, and signs off as appropriate.
• Evaluates appropriateness of patient inclusion into trials; order repeat labs if necessary, or screen-fail patients as needed. Counsels’ patients on seeking appropriate medical care when necessary.
• Reinforces study restrictions, diets, and study guidelines.
• Reviews and provides insight into impending CRFs, electronic CRFs, data clarification forms, and/or data queries.
• Reviews source documents, lab results, and procedures throughout the study.
• Assesses adverse events and drug reactions, thoroughly recording details, including the relationship to the study drug.
• Assists in reporting any serious adverse events (SAEs) to the PI.
• Participates in monthly staff meetings.
• Reads and understands the information in the Investigator's Brochure (IB), including the potential risks and side effects of the drug.
• Performs Clinical Research Coordinator duties.
• Occasional travel to Company sites, Investigator meetings, and/or Company meetings.
• Performs other miscellaneous job-related duties as assigned by your manager.

Requirements:

• Medical Degree (MD, DO))
• Minimum of 3 years’ experience in clinical research (preferred)
• In-depth knowledge of federal regulations regarding responsibilities of a Primary or Sub- Investigator. The Investigator is deemed competent when he/she can thoroughly manage project, read and understand the available information (IB) on the product under investigation, including the potential risks and side effects of the drug and possesses the ability to adhere to the study protocol and investigate the drug under investigation.

Continuing Education:

• GCP (Good Clinical Practice) – Must renew every 3 years
• IATA (dangerous goods handling) – Must renew every 2 years
• OSHA trainings

Competency Requirements:

• Excellent communication skills.
• Problem-solving skills.
• Planning/organizational skills.
• Customer service skills.
• Attention to detail and ability to follow clinical research protocols.
• Ability to work collaboratively with a multidisciplinary research team.
• Strong analytical and critical thinking skills.
• Adaptability to a fast-paced research environment.
• In depth knowledge of FDA-GCP regulations pertaining to protecting human rights and safety, ethical issues and clinical assessments when dealing with clinical research and human volunteers.

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