Principal Investigator
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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