Clinical Research Associate (CRA)

Clinical Research Associate (CRA) VitaKey is an exciting start-up founded out of the Langer Lab, MIT, developing and commercializing proprietary technology for controlled, targeted, extended, and sustained delivery of macronutrients, micronutrients, probiotics, biologics, small molecules, etc. to be included in everyday foods and beverages to improve human health. We are seeking innovative and motivated team members to be part of the company's next-phase of growth at our Durham NC HQ. Learn more about our company on our website at www.VitaKey.com Role Summary The Clinical Research Associate (CRA) responsibilities will involve supporting and executing on VitaKey clinical programs for evaluating VitaKey platform technologies. Responsibilities will also include working in an interdisciplinary role with formulation scientists, manufacturing engineers, business team members, and external partners (e.g., CROs) that are key to our clinical programs. You will serve as an independent contributor and have the opportunity to support our clinical programs. Duties and Responsibilities Trial Coordination : Plan, initiate, monitor, and close out clinical trial sites, ensuring all activities align with the study protocol and regulatory standards Site Management : Identify and assess suitable trial sites, coordinate site selection and initiation, and manage trial supplies and investigational products. Regulatory Compliance : Ensure adherence to GCP, SOPs, and applicable regulatory requirements. Prepare and submit regulatory documents for IRB and other regulatory approvals necessary for trial conduct. Monitoring and Oversight : Conduct regular site audit visits to monitor study progress, verify data accuracy, and ensure participant safety. Perform source data verification (SDV) and review case report forms (CRFs). Data and Documentation : Prepare and maintain all necessary trial documentation (protocol, adverse event forms, CRFs, etc.) as well as internal VitaKey SOPs for GCP compliance. Collect, review, and archive study documentation and reports. Prepare visit reports, track adverse events, and ensure proper documentation of all trial activities. Training and Support : Train site staff on trial procedures, GCP, and regulatory requirements. Provide ongoing support and guidance to investigators and research teams. Communication : Serve as the primary liaison between trial sites, sponsors, ethics committees, and regulatory agencies. Facilitate effective communication and problem-solving throughout the trial. Coordinate trial meetings (kickoff, closeout, DSMB, etc.) Risk Management : Identify, report, and mitigate risks and issues that may impact study integrity or participant safety. Clinical Science : Identify, evaluate, and summarize relevant clinical publications and manuscripts. Compile and present clinical trial outlines for evaluating nutrient pharmacokinetics, organoleptic properties, biodistribution, fate and function, and other clinical outputs of VitaKey formulations. Combine knowledge from formulations, manufacturing, and clinical outcomes to enable clinical studies that demonstrate competitive advantages of VitaKey formulations. Evaluate trial designs to ensure that they support desired claims. Perform necessary clinical statistical analysis such as power analyses, epidemiological modeling, PK/PD analysis, etc. Work with scientists within the group and with external laboratories, and present ideas and results Qualifications BS,MS or PhD with a minimum of 4-8 years of experience in industry or academia in designing, evaluating, or managing clinical trials Strong knowledge of GCPs Candidates with experience using trial data to generate health claims for nutritional or personal care products are preferred Experience working with professionals from formulation science, chemical engineering, bioengineering, pharmaceutical sciences, polymer chemistry, food science or allied disciplines Experience conducting power analyses, epidemiological modeling, PK/PD analysis, etc. Experience designing clinical trials evaluating pharmaceuticals, nutraceuticals, medical devices, proteins, carbohydrates, polymers, microparticles, probiotics, and/or lipids for health and/or performance outcomes Entrepreneurial and self-motivated work style; comfort in ambiguity Excellent cross-disciplinary skills in communicating ideas to both scientists and non-scientists Startup experience is highly valued, but not required Ability to adjust rapidly to changing priorities and technologies Ability to travel to clinical sites, as necessary