Job Description

Summary: The Principal Investigator (PI) will be responsible for overseeing and leading clinical trials from start to finish, ensuring scientific integrity, participant safety, and adherence to all regulatory requirements. The PI will manage all aspects of clinical research, including the development of protocols, study implementation, data management, and compliance with regulatory standards.

Duties and Responsibilities: The Principal Investigator:

• Attends Site Initiation Visits and/or training in-service for all current protocols.
• Completes required SOP training.
• Oversees and directs the study tasks delegated to the clinical team, ensuring full involvement and adherence to protocol and regulatory requirements. This includes assigning tasks and ensuring all team members follow protocols.
• Provides leadership and guidance to the clinical research team as needed, ensuring compliance with clinical trial protocols and high standards of performance.
• Supervises and assists in the training and development of the clinical team and support staff for clinical trials, ensuring everyone is appropriately trained and knowledgeable.
• Oversees recruitment efforts for clinical trials, ensuring that recruitment is in line with study goals and regulatory requirements. This may involve providing guidance and resources to assist the recruitment process.
• Sets schedules to accommodate patients onsite and/or offsite as necessary, which may include weekends and holidays.
• Conducts the informed consent process according to SOPs, ensuring the most current ICF version is used.
• Evaluates the eligibility of patients for inclusion in clinical trials, ensuring thorough and accurate assessment.
• Collects medical and surgical history, concomitant medication use, and adverse event information from participants.
• Documents source documents, inpatient activities, visit progress notes, and adverse events, maintaining accurate and complete records throughout the study.
• Reviews lab results, assesses clinical significance for any out-of-range or abnormal values, and signs off as appropriate.
• Evaluates the appropriateness of patient inclusion into trials, order repeat labs if necessary, or screen-fail patients as needed. Provides guidance on appropriate medical care when necessary.
• Reinforces study restrictions, diets, and study guidelines to participants.
• Reviews and provides insight into upcoming CRFs, electronic CRFs, data clarification forms, and/or data queries.
• Reviews source documents, lab results, and procedures throughout the study, ensuring the integrity of trial data.
• 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 or relevant parties as needed.
• Participates in monthly staff meetings to discuss progress, challenges, and updates regarding ongoing trials.
• Reads and understands the information in the Investigator’s Brochure (IB), including the potential risks and side effects of the drug or treatment being studied.
• Performs Clinical Research Coordinator duties as needed, supporting clinical trial activities.
• Occasionally travel to Company sites, Investigator meetings, and/or Company meetings as required.
• Perform other miscellaneous job-related duties as assigned by your manager.

This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.

Requirements:

• Must possess a valid medical license and be board-certified in a relevant medical field.
• Doctor of Medicine (M.D.), Doctor of Osteopathic Medicine (D.O.), Psychiatrist or equivalent degree in a relevant medical or scientific field.
• Current DEA license
• 5 years of clinical research experience, with at least 2 years in a leadership or supervisory role in clinical trials highly preferred
• In-depth understanding of safety reporting procedures and the ability to assess adverse events.
• In-depth knowledge of federal regulations regarding responsibilities of a Principal 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
• OSHA trainings

Competency Requirements:

• Excellent communication skills.
• Planning/organizational skills.
• Customer service skills.
• Attention to detail and ability to follow clinical research protocols.
• High level of professionalism and ethical conduct in clinical research and patient interaction.
• 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.

Physical Requirements and Environmental Factors:

• Approximately 20% travel required.
• Mid-level computer use
• On site 3-5 days a week
• Work is normally performed in a typical interior clinical/office environment.
• Prolonged periods of sitting at a desk and working on a computer.
• Lifting of 20 pounds and occasionally more than 20 pounds.

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