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MD/DO Consultant – Principal Investigator, Clinical Trials
Hawthorne Health. Accurately document findings and contribute to ongoing clinical trials, registries, or research protocols as applicable .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials, ensuring compliance with ICH-GCP guidelines and FDA regulations, while providing effective leadership to the clinical research team. Possesses strong clinical judgment and communication skills to facilitate collaboration with sponsors and regulatory authorities.
Highest-signal resume keywords
Principal Investigator ExperienceMedical Doctor (M.D.) DegreeCurrent Medical LicenseIn-Depth Knowledge of ICH-GCP GuidelinesLeadership and Team Management Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Trial ManagementPatient Assessment ReviewLaboratory Result InterpretationAdverse Event ManagementProtocol Deviation Handling
Soft Skills
Excellent Clinical JudgmentStrong Verbal CommunicationStrong Written CommunicationExceptional Organizational SkillsMeticulous Attention to Detail
Tools & Technologies
Good Clinical Practice (GCP)FDA RegulationsClinical Research ProtocolsInvestigational Product Management
Certifications & Qualifications
Board Certification in Relevant Specialty
Industry Keywords
Clinical TrialsContract Research Organizations (CROs)Institutional Review Boards (IRBs)Regulatory ComplianceEthical Conduct
About the role
Key responsibilities & impact- Accurately document findings and contribute to ongoing clinical trials, registries, or research protocols as applicable
- Oversee and manage all aspects of clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements
- Lead and supervise the clinical research team, including sub-investigators, study coordinators, and other site staff
- Delegate study-related duties appropriately to qualified personnel and ensure proper training and oversight
- Conduct remote review of patient assessments, including physical exams, medical histories, and eligibility screenings, to ensure appropriate participant enrollment
- Review and interpret laboratory results, ECGs, and other diagnostic tests
- Make critical medical decisions regarding participant care, adverse events, and protocol deviations
- Ensure accurate, complete, and timely collection and documentation of all study data
- Communicate effectively with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities
- Manage investigational product accountability, storage, and administration according to protocol and with the help of the on-site IP team
- Participate in site initiation visits, monitoring visits, audits, and inspections
- Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas
- Provide 3–5 hours per week of remote clinical oversight
- Attend the McAllen, TX site approximately 1–4 times per month for key visits
Requirements
What you’ll need- Experience as a Principal Investigator on at least 3 sponsor initiated clinical trials
- Medical Doctor (M.D. or equivalent) degree from an accredited institution
- Current, unrestricted medical license
- Board certification in a relevant specialty preferred
- Demonstrated in-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research
- Proven leadership and team management skills
- Excellent clinical judgment and decision-making abilities
- Strong verbal and written communication skills in English, with the ability to present complex information clearly and concisely
- Exceptional organizational skills and meticulous attention to detail
- Ability to manage multiple complex studies simultaneously and prioritize tasks effectively
- Commitment to ethical conduct and patient safety
- PI will need to be located within 1.5 hours driving distance to the site
Benefits
Comp & perks- Hourly compensation; rate negotiable based on experience
- Part-time 1099 contract opportunity