Sub Investigator Position Description

Position Overview

A perfect opportunity for doctors, PAs and APRNs who are looking for a change of pace from their day-to-day practice. AMR employs doctors, PAs and APRNs who are passionate about the future of medicine

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

To consistently embody AMR’s Core Values:

· Excellence and Consistency

· Collaborative Innovation

· Respect for our Subjects, Sponsors and Team Members

· Community

· Unimpeachable Ethics

The Sub-Investigator reports to the Principal Investigator

Classification: Exempt

Primary Responsibilities:

· Maintain current license to practice medicine.

· Assume responsibility as the 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.

· Perform physicals per study protocol, as needed

· 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.

· Primary Investigator responsibility in PIs absence, as delegated.

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

· Communicate and report to PI any issues or concerns on the progress of the study, as needed

· Attend Investigator Meetings and educational seminars.

· Other duties as assigned

Additional Responsibilities (Check If Applicable):

Community Liaison

Support the work of AMR Investigators to the capacity of your scope of practice and advise sites and local organizations on necessary procedures and guidelines for studies that AMR will be considering and/or participating in. You will serve as a liaison between site staff, investigators, business development, community members, study participants, sponsors, CROs, IRBs to existing protocols in conjunction with Project Management to the degree that your expertise lends content to discussions. You will collaborate with Business Development to bring new study opportunities to local physicians and clinics. You will work to extend the efforts locally of the Recruitment Center for Excellence by your collaboration with community organizations and providers.

Collaborate with all clinical trial patient and staff activities to ensure safety and efficacy of study drugs and devices.

Provide local support to clinical trial recruitment procedures and deadlines, to ensure timely recruitment and retention of patients.

Act as a liaison between clinical trial sites and the clinical trial teams, ensuring that any discrepancies or alterations to protocol are addressed and actions are taken in a timely manner.

Participate in regular discussions with the clinical trial team, providing insight into regulations related to clinical trials as needed.

Develop and implement educational programs to ensure proper compliance with clinical trial protocols.

Collaborate with local organizations to provide resources, services, and education related to clinical trials.

Participate in internal and external meetings as needed to discuss and review issues related to clinical trial protocols.

Desired Skills and Qualifications:

· At least 3 years' experience conducting clinical research trials as a Sub-Investigator, or other relevant experience.

· Possess a valid MD or DO medical license, PA or NP license

· Active license to practice medicine within state conducting trial

· 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.