Principal Investigator

Job summary

Responsible for conducting clinical trials in accordance with the research protocol, Good

Clinical Practices (GCPs), and federal/state regulations. Generates independent, high quality,

and reproducible results. Collaborate with our study team, as well as various medical,

pharmaceutical company and regulatory personnel to ensure the health and welfare of study

participants. Responsible for the management and integrity of the design, conduct, and

reporting of the research project and for managing, monitoring, and ensuring the integrity of any

collaborative relationships. Responsible for the direction and oversight of compliance,

financial, personnel, and other related aspects of the research project.

Essential Responsibilities And Duties

• Maintain current license to practice medicine.

• Maintain current board certification, if applicable

• Assume responsibility as the Principal Investigator for the duration of clinical trials

• Strong working knowledge of regulatory requirements and GCP standards

• Possess thorough understanding of the clinical research protocol and patient

population for which the trial is designed

• Ensures recruitment goals are reasonable and attainable

• Perform any evaluations deemed necessary for the conduct of the trial

• Complete training as required per sponsor’s vendors to obtain certification to conduct

testing and rating scales for specific protocols

• Conduct testing and rating scales per sponsor’s instructions and protocols. Completion

of all documentation, paper and electronic, as required per protocol

• Evaluate participants for clinical research trials based on their past medical history in

comparison to the protocol specific inclusion and exclusion criteria

• Ensure appropriate delegation and training of the clinical research staff

• Educate study staff on patient population and mechanism of action of the

investigational product

• Evaluate subject safety and compliance with the investigational product as specified in

the clinical research protocol as well as collaborate with the medical director

• Assess participant’s response to investigational therapy and evaluate any adverse

events

• Adhere to reporting requirements for safety reports, protocol noncompliance and any

other protocol required reports

• Ensure subject’s informed consent is obtained appropriately throughout the duration of

the clinical trial

• Adhere to the requirements detailed on the FDA 1572 or Statement of Investigator form

• Collaborate with Site Leadership to ensure company goals are met

• Provides key budgetary decisions and verifies that appropriate budgets and cost

projections are prepared to deliver the proposed project scope

• Attend Investigator Meetings and educational seminars.

• Assumes other duties and responsibilities as assigned. The above responsibilities are a

general description of the level and nature of the work assigned to this classification and

are not to be considered as all inclusive.

Education/Experience/Skills

• Must be able to effectively communicate verbally and in writing.

• Possess a valid M.D. or D.O. degree. Board Certified or Eligible.

• 1-3 years’ experience conducting clinical research trials as either a PI or Sub-investigator, or other relevant experience.

• MD. or D.O. required. Active DEA license, or able to obtain one. Active license to practice

medicine in the state of practice, or ability to obtain one.

• Medical knowledge and ability to provide clinical information to study teams;

• Knowledge of medications and general medical conditions;

• Knowledge and Understanding of GCP/ICH guidelines

• Possess a thorough understanding of the requirements of each protocol

• Experience in conduct of clinical trials;

• Demonstrating the proper education, training and experience to conduct the clinical

investigation

• Knowledge of drug delivery systems and ability to prepare injections, infusions, etc.;

• Skill in organization and record maintenance;

• Skill in developing and maintaining effective working relationships with supervisors and

co-workers;

• Ability to complete paperwork with precision and attention to detail;

• Ability to react calmly and effectively in emergency situations;

• Ability to interpret, adapt and apply guidelines and procedures;

• Ability to work independently as well as functioning as part of a team;

• Ability to communicate clearly, both verbally and in writing.