Clinical Research Coordinator

divh2Caris Life Sciences/h2pAt Caris, we understand that cancer is an ugly worda word no one wants to hear, but one that connects us all. Thats why were not just transforming cancer carewere changing lives./ppWe introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: What would I do if this patient were my mom? That question drives everything we do./ppBut our mission doesnt stop with cancer. Were pushing the frontiers of medicine and leading a revolution in healthcaredriven by innovation, compassion, and purpose./ppJoin us in our mission to improve the human condition across multiple diseases. If youre passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins./ph3Position Summary/h3pA Clinical Research Coordinator -Biorepository provides operational and regulatory support for the Caris sponsored studies and collaborative Pharma studies ensuring activities are conducted per standard operating procedures and best practice principles. Responsibilities will include, but not limited to, study documentation maintenance, leading site onboarding activities, driving site engagement through routine status meetings/ touch points, study enrollment/ accrual reporting, specimen tracking, accessioning, and inventory./ph3Job Responsibilities/h3ulliSuccessfully execute site onboarding process in an effective and timely manner/liliDevelop and maintain a thorough understanding of study content, workflows, and procedures to successfully conduct the Site Initiation Visit meeting and offer ongoing site support./liliLiaison with study sites and regulatory document team to ensure regulatory documentation is up to date./liliEnsures proper regulatory, legal, and financial disclosure documentation are on file in accordance with standard operating procedures, data management plan and/or study protocol./liliCommunicates cross functionally (internally and externally) on all research study operational changes; ensuring questions and issues are answered/addressed or provided to the appropriate group./liliMaintains workflows in accordance with approved Standard Operating Procedures (SOPs). Assists in process improvement within the department under the direction of manager./liliReviews specimen requests for proper approvals, maintains documentation of chain of custody, and routes for fulfillment./liliReviews associated specimen and subject submission documentation and verified accuracy of data entry./liliContinuously provides excellent customer service in an efficient and effective manner./li/ulh3Required Qualifications/h3ulliAssociate degree with biological science coursework required./liliCandidates should have 1-2 years experience in a Biorepository setting or Clinical Trial setting/liliProficient in Microsoft Office Suite, specifically Word, Excel, PowerPoint, Outlook, and general working knowledge of Internet for business use/li/ulh3Preferred Qualifications/h3ulliBS degree or higher degree with biological science/lili3-5 years experience/liliCandidates should have experience with clinical trial regulatory documentation or TMF./liliCandidates should have a strong understanding of laboratory settings and processes and must be able to adapt to varied levels of workload in a dynamic environment./liliLaboratory Information Management System or Sample Management System experience./liliCustomer service experience./liliGood Clinical Practice training, IATA training, and Human Subject Protection training./li/ulh3Physical Demands/h3ulliAbility to stand for more than 1 hour at a time, sit for more than 1 hour at a time./liliAbility to lift up to 30 lbs./li/ulh3Training/h3ulliEmployee will be required to complete Good Clinical Practices, Human Subject Protection, HIPAA, and IATA training./liliAll job specific, safety, and compliance training are assigned based on the job functions associated with this employee./li/ulh3Other/h3ulliWeekend/evening/holiday work may be required depending on business need, however, is not to be the norm./li/ulpConditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check (applicable for certain positions) and reference verification./ppThis job description reflects managements assignment of essential functions. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time./ppCaris 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./p/div