Principal Investigator/ Sub Investigator

2737 West Baseline Road, Tempe, United States

Alliance for Multispecialty Research

Posted on: September 2, 2020

Closing: October 02, 2020

Salary: Undisclosed

Position Type: Full Time

Job Description

Position Overview

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.

 

To consistently embody AMR’s Core Values:

  • Excellence and Consistency
  • Collaborative Innovation
  • Respect for our Subjects, Sponsors and Team Members
  • Community
  • Unimpeachable Ethics

The Investigator/Sub-Investigator reports to the General Manager.

Classification: Exempt

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. - PI responsibility/SubI in PIs absence.
  • Assess causality and rate severity of all AEs during the course of the protocol.
  • PI will provide continual oversight of the study protocol.
  • Attend Investigator Meetings and educational seminars.

 

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 degree, PA or NP 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.

Alliance for Multispecialty Research

Posted on: September 2, 2020

Closing: October 02, 2020

Salary($): Undisclosed

Position Type: Full Time

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