| Position Overview: The Clinical Research Director will manage all aspects of clinical research studies including enrolling autoimmune patients and healthy controls. Manage multiple company clinical study sites and company decentralized digital studies to oversee participant recruitment and enrollment, medical records data extraction, scheduling/follow-up for sample collection and other study requirements as applicable. Oversee adherence to SOPs, Good Clinical Practice, and other applicable industry regulations. Prepare Institutional Review Board (IRB) protocols, manage the development and implementation of clinical processes, procedures, and programs under the guidance of the Principal Investigator. Manage the collection, analysis, and evaluation of clinical/medical data, production of required progress reports to IRB, granting, and other regulatory agencies. SPECIFIC RESPONSIBILITIES: - Lead design of our studies with focus on economic data collection and analyses and demonstrate how our digital solutions enhance our biomarker-based test offerings
- Manage the day-to-day activities related to the Company’s clinical research studies and oversee the status of the various stages that the study undergoes
- Recruit clinical study sites and be responsible for contracting with clinical sites, mobile phlebotomy services and laboratory testing services as required to meet study objectives Oversee contracted services and coordinate study logistic operations
- Supervise the work carried out by the clinical coordinator on all aspects related to Subject Recruitment, Participant Enrollment, and Medical/Clinical Data Extraction and Analysis, and Sample Collection to ensure that these activities are completed on time and per the study protocols
- Assist Principal Investigator in preparing IRB protocols and progress reports to ensure that clinical studies are being conducted in compliance with IRB human subject regulations
- Manage the creation and development of recruitment materials, study protocols, and consent forms for clinical studies
- Assist with strategic planning and budget process related to the studies
- Prepare reports on study timelines and progress and share with internal and external stakeholders as may be required from time to time
- Assist the Principal Investigator with the publication pipeline including initiating potential publications related to ongoing studies and assisting with the creation and editing from draft to final publication
- As needed, performs various duties as needed to successfully fulfill the functions of the position
EXPERIENCE - Required Minimum 5 years’ experience in the clinical research or medical device industry, preferably at a diagnostic company or a CRO
- Required Minimum 5 years’ experience in clinical study management, developing clinical study or clinical trial protocols, preparing IRB submissions, managing clinical study enrollment and coordination
- Demonstrated experience in managing clinical research studies including helping to develop the economic evidence necessary to demonstrate efficacy and cost-effectiveness of our tests to a varied spectrum of stakeholders including patients, physicians, payers, and other policymakers
- Demonstrated knowledge of regulatory and reimbursement requirements for diagnostics tests and experience in designing and implementing studies required to demonstrate clinical utility for the tests
KNOWLEDGE/SKILLS/ABILITIES: - Excellent understanding of clinical trial and clinical research study concepts, guidelines, principles, and practices
- Excellent organizational, planning, and communication skills with ability to communicate effectively both orally and in writing
- Good working knowledge of HIPAA, GCP guidelines, and other applicable regulatory guidelines
- Demonstrated ability to translate study results into economic value messages
- Demonstrated ability to learn and effectively utilize all applicable business software including, but not limited to: project management software, practice management software, EMR software, Word, Excel, Outlook, and PowerPoint
- Excellent problem solving and effective decision-making skills
- Proactive manager possessing leadership and conflict resolution skills
- Ability to work well both independently and as a team member
- Experienced with handling multiple tasks, prioritize tasks and solve problems in stressful situations
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