MD/DO Consultant - Principal Investigator - Conroe, Texas

Benefits

Qualifications

• •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
• •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
• •This position requires being on site in Conroe, TX ~2 times per month for key visits
• •8 more items(s)

Responsibilities

• •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
• •3-5 hours per week of remote clinical oversight
• •10 more items(s)