Clinical Trial Lead

OVERVIEW This role will lead the coordination of research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and includes the opportunity to help spearhead on-site efforts for Topography’s partner healthcare groups. This role will be evaluated on practice success and metrics, patient experience, protocol management and adherence, data quality, and the ability to train, retain, and grow a high-performing team. This role will require a track record of excellence as a CRC, including developing successful relationships with providers. You will need to be comfortable conducting 5+patient visits a day and independently solving problems. You will need to lead with empathy for patients, build trust with a variety of stakeholders, and care deeply about creating new access to clinical research in communities across the country.   KEY RESPONSIBILITIES Manage all research personnel at the site while overseeing all site level research activities. Act as a clinical trial lead to execute trials conducted within one or more physician practices, including but not limited to: Visit preparation activities Visit follow-up activities Supply and inventory management Third party vendor management Lead patient recruitment and enrollment of eligible patients across the portfolio of active trials Oversee and conduct patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. Independently administer the informed consent process with care and quality  Ensure protocol adherence and high data integrity across site and study teams Ensure high quality source data capture and documentation Oversee study start-up and planning, including PSVs and SIVs Oversee IRB submission and correspondence Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process and being the point of contact for monitors IP management, dispensation and accountability Adverse Event management, tracking, and follow-up Data entry to CRF/EDC and query resolution, to meet stated contract obligations Oversee study close-out, including COVs Protocol deviation tracking, reporting, and reconciliation, including strategies to prevent repeat occurrence Train and mentor junior research staff  Direct line management of site staff, including Research Assistants, CRCs, and Senior CRCs Using and helping improve Topography’s proprietary tool set Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation Lead Quality Control activities including routine QC checks during and following study visits. Key to your role will be implementing processes and policies to increase data quality.  Project Management Metrics and Practice Success. You will represent Topography and the research team locally at the practice-level, serving as an on-site clinical research expert and liaison to providers and practice management Use a metrics-driven approach to organize the on-site team and maximize time on task Success of the Team. You will be the day-to-day leader of a growing team.  Achieve team goals with hands-on training, coaching, and mentorship Create an efficient and positive work environment, focused on our mission and the day-to-day work required to achieve that mission. You will be expected to cover all functions with a successful research program where necessary Any other duties assigned by manager   MINIMUM QUALIFICATIONS Bachelor's degree or equivalent combination of training and experienceValid medical license  7+ years of experience as a Clinical Research Coordinator, Senior CRC,  and/or Research Assistant, with other similar roles as additional experience 7+ years of experience independently coordinating industry studies, from study startup to close out 7+ year track record of delivering clean data and a high-quality patient experienc 7+ years demonstrated track record of creating success for a team, and mentoring and leading colleagues to achieve discrete goals 7+ year expert knowledge of FDA regulations and ICH/GCP guidelines Experienced in both  interventional and biomarker or observational clinical trials.  PREFERRED QUALIFICATIONS Previous people leadership experience  Previous site level experience with sponsor and/or FDA audits Experience in Phase 2, 3 and 4 trials