At K2 Medical Research, we are transforming healthcare by delivering tomorrow’s treatments today. As a rapidly growing clinical research organization across Florida, Tennessee, and Rhode Island, we lead multiphasic trials in therapeutic areas ranging from neurodegenerative to cardiometabolic medicine. Our culture is grounded in clinical excellence and a patient-first mission. We are seeking mission-driven individuals ready to play a meaningful role in bringing life-changing treatments to the patients who need them most.
K2 is seeking a Principal Investigator (Clinical Research Physician) to support our clinic out of Orlando (Maitland), FL in a full-time capacity.
The Principal Investigator (PI) provides clinical leadership and medical oversight for trials across K2's therapeutic areas. The PI is accountable for the conduct, integrity, and regulatory compliance of every study under their direction, and for the safety and well-being of every participant enrolled.
The ideal candidate is a physician with strong clinical expertise who wants to help bring new treatments to patients. They are equally comfortable leading a busy multi-protocol portfolio, mentoring a site team, and representing K2 to sponsors.
Responsibilities:
- Study leadership and oversight: Serve as PI and medical lead for clinical trials at K2, from site selection and start-up through close-out. Oversee a portfolio of roughly 10–20 active trials across multiple sponsors and protocols. Delegate study tasks only to staff whose qualifications, training, and scope of practice support them, and supervise all delegated staff, as documented on the delegation log. Be on site during normal clinic operating hours and available after hours for participant safety questions; arrange sub-investigator coverage during any absence. Respond promptly to time-sensitive clinical questions, abnormal lab findings, and safety concerns raised by coordinators and other site staff.
- Operational performance and accountability: Own study performance goals, including enrollment, screening-to-randomization conversion, retention, data quality, and protocol adherence. Actively drive recruitment through physician referral outreach, review of their own patient population, and community engagement. Review medical reasons for screen failures, early withdrawals, and missed visits, and identify clinically appropriate ways to improve conversion. Work with site leadership to resolve clinical bottlenecks that affect study timelines, participant flow, or site productivity. Take ownership of the study portfolio and contribute to the site's operational and financial success.
- Participant safety and clinical care: Determine participant eligibility through history, physical examination, and review of labs, imaging, and other diagnostics. See participants at designated study visits to perform protocol-required clinical assessments and physical examinations. Provide ongoing medical oversight of enrolled participants, including review of concomitant medications and changes in medical status. Make the final assessment of adverse event severity, seriousness, causality, and expectedness, and ensure AEs and SAEs are documented and reported within required timelines. Review and acknowledge sponsor IND safety reports and SUSARs, and make sure they are submitted to the IRB as required. Manage emergency unblinding according to protocol and document the medical rationale. Review and sign off on lab results, ECGs, and other safety data promptly. Build trusting relationships with participants to support engagement, protocol adherence, and retention. Protect participant rights, privacy, confidentiality, safety, and welfare throughout each trial.
- Regulatory compliance and quality: Ensure full compliance with ICH-GCP, FDA regulations (including 21 CFR Parts 50, 54, 56, and 312), HIPAA, IRB requirements, sponsor requirements, and K2 SOPs. Sign Form FDA 1572 and financial disclosure forms and fulfill the obligations they carry. Review Clinical Study Agreements to understand investigator obligations and study requirements. Oversee informed consent so it is obtained and documented properly for every participant. Maintain accountability for investigational product, including storage, dispensing, accountability records, and reconciliation. Identify, resolve, and prevent protocol deviations, lead corrective and preventive action plans, and resolve medical data queries promptly. Report unanticipated problems to the IRB and sponsor as required. Maintain accurate, contemporaneous source documentation and complete medical reviews, signatures, and eCRF sign-offs within K2 and sponsor timelines, keeping all records audit-ready. Oversee the Investigator Site File and essential documents, and ensure records are retained for the required period. Lead the site through monitoring visits, sponsor audits, IRB audits, and FDA inspections.
- Team leadership and collaboration: Partner with the Site Director to lead a high-performing site, sharing accountability for execution, enrollment, quality, and team effectiveness. Work closely with sub-investigators, coordinators, raters, and regulatory staff to execute studies efficiently. Serve as the site's clinical resource on protocol interpretation, clinical assessments, and escalation of medical concerns. Train and mentor investigators and site staff on trial conduct and therapeutic-area knowledge, and develop Sub-Investigators toward PI roles. Promote a culture of accountability, collaboration, participant-centered care, and continuous quality improvement.
- Sponsor relations and growth: Participate in feasibility reviews, pre-study and site initiation visits, investigator meetings, and sponsor or CRO calls. Meet with medical monitors, IRBs, and FDA representatives as needed, and present complex clinical information clearly to sponsors, regulators, and K2 leadership. Contribute medical input to feasibility assessments and protocol development. Partner with Business Development and Marketing to represent K2's capabilities and win studies from current and prospective sponsors. Stay current on clinical advances and the research pipeline in relevant therapeutic areas.
Professional standing
- Maintain all required licenses, board certifications, GCP training, and credentials for clinical trial practice.
- Perform other duties as assigned.
Knowledge, Skills, & Abilities:
- Strong working knowledge of clinical trial operations, regulatory requirements, and participant safety.
- Proven ability to manage multiple concurrent trials and competing priorities without compromising quality.
- Proficiency with EDC and CTMS systems and standard office software.
- Excellent leadership, clinical judgment, and communication skills.
Qualifications:
- MD or DO from an accredited institution, with broad-based post-graduate clinical experience.
- Board certification strongly preferred.
- Active, unrestricted medical license in the state where the PI will conduct trials, or eligibility to obtain one before start date.
- Active, unrestricted DEA registration.
- No history of FDA debarment, disqualification, or sanctions.
- At least 2 years of experience as a Principal Investigator or Sub-Investigator in industry-sponsored clinical trials.
- Current GCP certification (or willingness to complete before start date).
Preferred Experience
- Prior experience as a Principal Investigator on industry-sponsored Phase II–IV trials.
- Experience across multiple therapeutic areas and protocol types, including outcomes trials or large multi-center programs.
- Familiarity with specialized study endpoints, such as biomarkers, imaging, and clinical rating scales.
- Established patient population or referral network in the local community.
- Scientific publications, presentations, or leadership in relevant research initiatives.
At K2 Medical Research, people come first—and compassion fuels discovery. Join the K2 family and bring your warmth, curiosity, and collaborative spirit to a team connecting patients, physicians, and researchers to move medicine forward.
Meaningful work. Benefits that support you. Full-time employees enjoy medical, dental, and vision options; supplemental insurance; a 401(k) with immediate employer match; generous PTO; and paid holidays. Our four-day workweek—10-hour shifts, Monday through Thursday—helps make room for life beyond work. Fridays are reserved for critical business needs or administrative tasks; otherwise, start your weekend early.
Different perspectives. Shared purpose. We’re an equal opportunity employer committed to an inclusive workplace. All qualified applicants receive consideration without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, or veteran status.
We provide reasonable accommodations for qualified individuals with disabilities. Need an accommodation during the application or interview process? Contact Talent@k2med.com—we’re here to help you shine.
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