Job Type: Part-time

Pay: From $150.00 per hour

Expected hours: 10 – 30 per week

Position Overview

A perfect opportunity for physicians who are looking for a change of pace from their day-to-day practice.

Physicians will serve as a Principal or Sub-Investigator for clinical trials involving pharmaceuticals and medical procedures. The Principal Investigator is responsible for conducting clinical trials in accordance with the research protocol, Good Clinical Practices (GCPs), and federal/state regulations. The PI will collaborate with our study team, as well as various medical, pharmaceutical company and regulatory personnel to ensure the health and welfare of study subjects.

Principal Investigator is expected to work closely with and in partnership with the Site Manager or General Manager to conduct clinical trials. This partnership is essential to the success of the site. From an organizational chart perspective, the Principal Investigator is part of the Site Manager or General Manager’s team and reports up accordingly.

Primary Responsibilities:

· Maintain current license to practice medicine.

· Assume responsibility as the Principal or Sub-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.

· Perform evaluations on subject as needed per protocol.

· Perform and supervise/review ratings performed by outside physicians, as needed, in accordance with the clinical research protocol.

· 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 subjects for clinical research trials based on their past medical and psychiatric 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 study medication/device.

· Evaluate subject safety and compliance with the study medication as specified in the clinical research protocol as applicable.

· Provide detailed study related documentation as required by the clinical research trial to ensure data integrity.

· 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 Statement of Investigator form.

· Collaborate with Site Leadership to ensure operations goals are met.

· Evaluate and report all Serious Adverse Events during the trial.

· Assess causality and rate severity of all AEs during the conduct of the protocol, as delegated.

· PI will provide continual oversight of the study protocol.

· 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-Investigator, or other relevant experience.

· Possess a valid MD or DO medical license,

· Active license to practice medicine within state

· Demonstrate leadership skills, including ability to effectively supervise individuals and teams.

· Strong interpersonal and leadership skills, self-motivation, and high personal integrity and ethics required

· Ability to quickly adapt to working in a wide variety of dynamic therapeutic areas of medicine.

· Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing circumstances).

· Strong written, verbal communication and interpersonal skills.

· Demonstrated ability to exercise standard Universal Precautions; in the alternative, the ability to quickly learn and apply Universal Precautions.

· Understanding of FDA regulations, ICH guidelines and Good Clinical Practices.

Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.

** 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.

Benefits:

• 401(k)
• Health insurance

Schedule:

• 8 hour shifts
• Monday to Friday

Ability to Relocate:

• Hamden, CT