Clinical Research Investigator
- 🇺🇸 United States
- On-site
- 20 months ago
- GCP
- ICH-GCP
- IEC
- ICH
- Regulatory Compliance
Job Summary
The Principal Investigator (PI) serves as the overall medical, scientific, and regulatory lead for clinical trials conducted at the Fort Worth site. The PI is responsible for ensuring the ethical conduct of the study, participant safety, data integrity, and full compliance with protocol, GCP, and all applicable regulatory requirements.
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Key Responsibilities:
Oversight & Leadership
- Provide overall leadership and direction for the clinical trial and investigational team.
- Ensure all trial activities adhere to the approved protocol, ICH-GCP, FDA regulations, IRB requirements, and sponsor expectations.
- Delegate tasks appropriately to Sub-Investigators and the Fort Worth clinical staff while maintaining oversight responsibility.
Participant Safety & Medical Care
- Oversee and ensure the medical care and safety of all participants enrolled in the trial.
- Conduct or supervise clinical assessments, physical exams, and determination of participant eligibility.
- Evaluate, manage, and document adverse events and serious adverse events in accordance with regulatory timelines.
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Regulatory & Compliance
- Serve as the signatory and accountable individual on FDA Form 1572 (or local equivalent).
- Ensure timely and accurate submission of documents to the IRB/IEC (initial submissions, amendments, safety reports, deviations, continuing reviews).
- Maintain complete, accurate, and verifiable source documentation and medical records.
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Protocol Execution & Study Conduct
- Confirm participant eligibility and informed consent prior to trial enrollment.
- Oversee drug/device accountability and ensure proper storage, dispensing, and documentation.
- Review lab results, clinical findings, and participant progress throughout the study.
- Monitor protocol adherence and address deviations or compliance issues.
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Data Integrity & Quality Assurance
- Ensure accuracy, completeness, and consistency of all study data.
- Review and sign off on CRFs/eCRFs, medical data, and safety documentation.
- Support monitoring visits, audits, and inspections; address findings promptly.
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Collaboration & Communication
- Serve as the primary contact for sponsors, CROs, monitors, and regulatory bodies.
- Provide ongoing training and supervision to the study team regarding protocol updates and safety requirements.
- Participate in investigator meetings and scientific discussions relevant to the protocol.
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Qualifications
- Medical degree (MD, DO) or equivalent with an active, unrestricted Texas medical license.
- Internal medicine and family practice specialties preferred, although will consider candidates with other backgrounds.
- Board certification is preferred.
- PI experience (at least one study) preferred, although will consider candidates with other clinical research experience.
- Strong understanding of GCP, ICH guidelines, FDA regulations, and clinical trial processes.
- Demonstrated leadership, decision-making, and communication skills.
- Ability to commit one full day or two half-days per week on-site in Fort Worth, with interest in expanding time over the long term a plus.
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Core Competencies
- Clinical judgment & patient-centered care
- Ethical and regulatory compliance
- Leadership & team management
- Critical thinking & problem solving
- Documentation accuracy & attention to detail
- Effective collaboration with cross-functional teams
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Why Join Cedar Health Research
- Flexible, part-time schedule that fits alongside an existing clinical practice
- An experienced, dedicated Fort Worth site team that handles day-to-day study operations
- Centralized business development, patient recruitment, data management, and regulatory teams that support the PI role
- Existing relationships with multiple sponsors, providing a steady pipeline of studiesÂ
- A clear path to a full-time role for those who want to grow their research career
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Equal Opportunity Employer Statement
Cedar Health Research is an Equal Opportunity Employer. We are committed to creating an inclusive, welcoming, and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, gender identity or expression, sexual orientation, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law.
We believe that a diverse workforce strengthens our organization and enhances our ability to serve our communities. Cedar Health Research upholds all applicable federal, state, and local employment laws and is dedicated to providing a fair, respectful, and equitable hiring and employment experience for all team members.
Qualifications
Qualifications
- Medical degree (MD, DO) or equivalent with an active, unrestricted Texas medical license.
- Internal medicine and family practice specialties preferred, although will consider candidates with other backgrounds.
- Board certification is preferred.
- PI experience (at least one study) preferred, although will consider candidates with other clinical research experience.
- Strong understanding of GCP, ICH guidelines, FDA regulations, and clinical trial processes.
- Demonstrated leadership, decision-making, and communication skills.
- Ability to commit one full day or two half-days per week on-site in Fort Worth, with interest in expanding time over the long term a plus.
Clinical Research Investigator · CEDAR HEALTH RESEARCH LLC