Principal Investigator

Care Access

Tyler, TXFull-time

Behavioral Health Market Context

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Benefits

The expected salary range for this role is $200,000 - $400,000 USD per year for full time team membersBenefits & Perks (US Full Time Employees)Paid Time Off (PTO) and Company Paid Holidays100% Employer paid medical, dental, and vision insurance plan optionsHealth Savings Account and Flexible Spending AccountsBi-weekly HSA employer contributionCompany paid Short-Term Disability and Long-Term Disability401(k) Retirement Plan, with Company Match5 more items(s)

Qualifications

  • Excellent written and verbal communication skills
  • Ability to effectively prioritize tasks in a fast-paced environment
  • Attention to detail and ability to maintain confidentiality when handling sensitive information
  • Critical thinking, dynamic problem-solving skills
  • Certifications/Licenses, Education, and Experience:
  • Training and certification in Good Clinical Practice (GCP)
  • MD or DO with an active, unrestricted medical license (medical license must be valid in the state in which the research is conducted)
  • Physical demands associated with this position Include: The ability to use keyboards and other computer equipment
  • Walking - 20%
  • Standing - 20%
  • Sitting - 20%
  • Lifting - 20%
  • Up to 25 lbs, over 25 lbs, & overhead
  • Driving - 20%
  • 11 more items(s)

Responsibilities

  • As the Principal Investigator, you will be responsible for oversight of all clinical trials according to study protocols, company processes, and GCP
  • Provide overall medical oversight and medical review of protocols in conformance with good clinical practice
  • Review sponsor provided safety reports.
  • Review and maintain accurate case report forms.
  • Ensure that the safety and well-being of all participants in the study at the trial site are protected
  • Assess subject response to therapy, evaluate and address adverse experiences
  • Perform physical assessments, examinations and study procedures as required by study protocols
  • Train Sub-Investigators and study staff members on protocol and protocol specific procedures
  • Provide medical support to sub-investigators and study staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
  • Review the inclusion/exclusion criteria, endpoint criteria, and investigational product use with the internal research team.
  • Complete the necessary Care Access and protocol specific trainings
  • Comply with ICH GCP (International Conference on Harmonization – Good Clinical Practice) and all applicable regulatory requirements
  • Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies
  • This role requires 100% of work to be performed on site
  • Travel: This is an onsite position with less than 10% travel requirements
  • Occasional planned travel may be required as part of the role
  • Exposure to blood borne pathogens - Yes
  • 14 more items(s)


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