Principal Investigator

About the role

We are seeking a highly skilled and experienced Principal Investigator to join our team. As the Principal Investigator, you will be responsible for overseeing all clinical trials according to study protocols, company processes, and GCP.

Responsibilities

• 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

Requirements

• Excellent written and verbal communication skills
• Ability to effectively prioritize tasks in a fast-paced environment
• Critical thinking, dynamic problem-solving skills
• Certifications/Licenses, Education, And Experience
• Minimum Education: MD or DO with an active, unrestricted medical license (medical license must be valid in the state in which the research is conducted)
• Minimum Experience: Previous experience as a Principal Investigator is required; 2 years prior experience as a Principal Investigator or Sub-Investigator, preferred
• Training and certification in Good Clinical Practice (GCP)

Qualifications

The Expertise Required 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 Minimum Education: MD or DO with an active, unrestricted medical license (medical license must be valid in the state in which the research is conducted) Minimum Experience: Previous experience as a Principal Investigator is required; 2 years prior experience as a Principal Investigator or Sub-Investigator, preferred Training and certification in Good Clinical Practice (GCP)

Benefits & Perks

• Paid Time Off (PTO) and Company Paid Holidays
• 100% Employer paid medical, dental, and vision insurance plan options
• Health Savings Account and Flexible Spending Accounts
• Bi-weekly HSA employer contribution
• Company paid Short-Term Disability and Long-Term Disability
• 401(k) Retirement Plan, with Company Match

Pay

The expected pay range for this role is $200,000 - $400,000 USD per year for full time team members.

Schedule

This is an onsite position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.

Physical Demands

• 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%

Location

Location: Brandon, FL.

Mandatory Employer Disclosures

• Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
• Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
• Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
• Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.
• Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment.
• Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.