Clinical Trial Principal Investigator

Location: Missoula, MT

Duration: 8 - 10 weeks during Spring 2019 - Delayed, we are still accepting resumes

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Position Description:

 

Looking for a Physician located in Missoula, MT who is familiar with Autism Spectrum Disorder (ASD) to lead investigation in a 4 week, 45 participant, medical device clinical trial. This trial is intended to lead to FDA Clearance, peer-review, and publication.

 

As Principal Investigator (PI), you will be responsible for the overall conduct of the clinical trial conducted at our local Medical Research Center. You will be working closely with trial subjects, your Clinical Research Associate (CRA), Study Nurse, the Clinical Research Manager, and Institutional Review Board (IRB) to ensure the health and welfare of study participants. 

 

Even if you have never previously been a Principal Investigator or conducted a Clinical Trial, all local Physicians with extensive knowledge of Autism Spectrum Disorder will be considered. The Clinical Research Manager and staff will train and guide you to ensure all the IRB and regulatory requirements are met. Knowledge of Medical Device Clinical Trial is preferred but not required.

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Type of Trial:

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We will be conducting this trial using a double blind, placebo controlled, randomized study, and using daily self (if the trial participant is verbal), or parental (if non-verbal), naturalistic self-reporting and weekly blood tests.

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PI Duties and Responsibilities

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• Responsible for ensuring that the clinical trial is conducted according to the investigational plan and all applicable regulations

• Responsible for protecting the rights, safety and welfare of study participants

• Conduct the trial within the protocol, GCP and applicable regulatory guidances

• Review and evaluate protocols and results

• Enter data, notes, and work within an electronic Quality Management System (QMS)

• Perform pre-study, on-study and post-study physical examinations and lab review to ensure that the physical and mental well being of participants is undiminished throughout the study

• Interact with regulatory bodies as relevant to clinical operations

• Liaise with the Sponsor and Clinical Research Manager regarding study design, scheduling and protocols

• Present protocols at IRB (Institutional Review Board) meetings as required

• Inform IRB and Sponsor as appropriate of relevant events

• Review and sign CRFs/eCRFs at the conclusion of the study

• Weekend and off-hours work as necessary

• Prepare a report on findings for publishing

 

This is not intended to be an exhaustive list of all responsibilities, duties and skills required of the Principal Investigator during this clinical trial.

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Skills/ Qualifications

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• Ability to read, write, speak and interpret the English language

• M.D. or D.O.

• U.S. Board Certification/ DEA license

• Active license to practice medicine in the State of Montana, or an active license transferrable to Montana within 3 months

• Experience and knowledge with Autism Spectrum Disorder (required)

• Experience in conducting clinical research (preferred but not required)

• Experience with the FDA Medical Device Approval process (preferred but not required)

 

 

To Apply:

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Please email your CV or resume, and any links of scientific works to hello@autistalline.com