Clinical Data Monitor I

Position Summary The Clinical Data Monitor I is responsible for clinical data management activities for the Caris protocols and projects at the Caris Precision Oncology Alliance sites. The position will ensure the highest standards for clinical data integrity and quality are maintained in alignment with critical research efforts aimed to improve the treatment, health and medical outcomes for oncology patients. This position provides support to both external and internal research coordinators in their function of patient enrollment, data collection, and data query activities. These responsibilities will involve management of all clinical investigative sites according to the Federal Code of Regulations, Good Clinical Practices (GCP), Good Registry Practices (GRP), ICH Guidelines, local regulations, and Compliance SOPs and/or Sponsor SOPs. Job Responsibilities Maintains proficient knowledge of EDC functionality for purposes of training, change proposals, and user acceptance testing Establish and maintain relationships with the site data & regulatory coordinators Responsible for Quality Control of submitted Case Report Forms (CRFs) including source document verification and issuing queries Will act as an Evaluator for the internal Clinical Research Coordinator in training; must provide extensive, informative feedback to the trainee Maintains regulatory documentation for all assigned sites and study staff Responsible for site creation, within the EDC, of newly onboarded sites Perform QC audits of the clinical database Support and adhere to Good Clinical Practices (GCP) guidelines, FDA, Institutional Review Board (IRB) and HIPPA regulations, Site Operating Procedures and ethical standards for the conduct of research clinical trials. Work closely with onsite team to confirm appropriate consenting is being performed and documented prior to data abstraction Communicate effectively with the research team, investigator(s), study sponsor and ancillary staff. Required Qualifications Bachelor’s degree preferred Requires 3-5 years of experience in data collection activities within a GCP/clinical research regulatory environment Proficient in Microsoft Office Suite Experience with EDC systems Clinical study experience in Oncology Strong medical terminology understanding Ability to work independently and make decisions. Ability to prioritize, meet deadlines, and manage multiple projects simultaneously. Ability to build trust with site personnel and communicate with concerned personnel. Detail oriented, demonstrating a passion for the critical insights that could come for patients through the research engagement. Demonstrates problem solving skills and ability to deliver solutions to clients. Demonstrates excellent written and verbal communication in English Projects a professional and positive interaction with internal/external parties with appropriate communication and collaboration. Proposes, implements, and evaluates appropriate resolutions Conditions of Employment: Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification. Preferred Qualifications Research Coordinator Certification preferred (SoCRA, ACRP) Physical Demands Must possess ability to sit and/or stand for long periods of time. Employee may be required to lift routine office supplies and use standard office equipment. Training All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. Good Clinical Practices (GCP) Human Subject Protection (HSP) Training SEER Primary Site Training Multiple Primary & Histology Rules AJCC Staging Other This position requires periodic travel and some evenings, weekends and/or holidays. Annual Hiring Range $70,000 - $80,000 Actual compensation offer to candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level. The pay ratio between base pay and target incentive (if applicable) will be finalized at offer. This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability. Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation. Our laboratory is the heart of what we do. Learn more about our laboratory and the team of histologists who help fulfill our purpose everyday.

Salary : $70,000 - $80,000