Clinical Data Coordinator I (Hybrid role - 3 days in office)

Caris Life Sciences; Irving (TX); Vor Ort; USD 64.000 - 80.000; Vollzeit

Zusammenfassung

Caris Life Sciences seeks a Clinical Data Coordinator to manage data for Oncology protocols within the Caris Precision Oncology Alliance. You will ensure high data integrity, review source data, and enter into EDC systems, while adhering to GCP and regulatory standards.

The role requires 3–5 years of data collection experience in a regulatory environment, strong medical terminology, and excellent communication skills. Occasional travel to sites may be necessary.

Qualifikationen

• 3–5 years of data collection experience in a GCP/clinical research setting.
• Knowledge of GCPs, ICH guidelines and CFR regulations.
• Oncology clinical study experience and strong medical terminology.
• Experience with EDC systems and data validation processes.
• Proficient in Microsoft Office; strong documentation and reporting skills.
• Ability to travel to multiple investigative sites as needed.

Aufgaben

• Abstract clinical data from source documents for oncology studies.
• Enter data into study-specific EDC case report forms.
• Clean and verify data accuracy; resolve data queries.
• Update EDC after data verification and tracking of CRF completion.
• Coordinate with onsite teams to ensure proper consent documentation.
• Perform QC audits of the clinical database and ensure regulatory compliance.
• Communicate findings with research team, sponsors, and staff.

Kenntnisse

Data collection in clinical trials

GCP/ICH/CFR knowledge

Medical terminology

Project planning & reporting

Training & mentorship

Communication skills

Tools

EDC systems

Microsoft Word

Microsoft Excel

Outlook

Jobbeschreibung

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives.We 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.But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose.Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.Position SummaryThe Clinical Data Coordinator is responsible for clinical data entry activities for the Caris Medical Affairs 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. Responsible for the collection and review of clinical protocol research data; Interpretation of data (including appropriate source documentation) for entry into computerized databases; Good understanding of data definitions and case report forms and other information related to data collection for clinical research. Must respond to queries in a timely fashion. Schedule on-site visits to perform data review and EDC data entry.Job ResponsibilitiesAbstract clinical data from subject source documentation.Enter clinical data into the study specific EDC case report forms.Clean the clinical data to verify accuracy.Update the EDC following verification of subject data, including the resolution of data queries.Track site goals and case report form completion.Prioritize site cases for analysis.Maintain study specific documentation.Perform QC audits of the clinical database.Support and adhere to Good Clinical Practices (GCP) guidelines, FDA, Institutional Review Board (IRB) and HIPAA 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.Maintain to Caris and Site requirements for source document management and request for information.Act as site designated entry person.Willingness to travel to multiple investigative sites if required.Communicate effectively with the research team, investigator(s), Clinical Research Associate(s), study sponsor and ancillary staff.Required QualificationsPosition requires 3-5 years of experience in data collection activities within a GCP/clinical research regulatory environment.Knowledgeable in critical elements for success in clinical trials. GCPs, ICH, and Code of Federal Regulations.Clinical study experience in the field of Oncology.Strong medical terminology understanding.Experience in both small and large scale project planning and reporting with strong communication and presentation skills.Experience in providing training for both internal and external staff with a mentorship approach for less experienced colleagues.Experience with EDC systems.Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.Physical DemandsMust possess ability to sit and/or stand for long periods of time.TrainingAll job specific, safety, and compliance training are assigned based on the job functions associated with this employee.OtherThis position may require occasional evenings and overtime.Annual Hiring Range$64,000 - $80,000Actual compensation offer to candidate may very from posted hiring range based upon geographical location, work experience, education, and/or skill level. The pay ratio between base pay and target incentive (if applicable) will be finalized at offer.Description of BenefitsHighly competitive and inclusive medical, dental and vision coverage optionsHealth Savings Account for medical expenses and dependent care expensesFlexible Spending Account to pay for certain out-of-pocket expensesPaid time off, including: vacation, sick time and holidays401k match and Financial Planning toolsLTD and STD insurance coverages, as well as voluntary benefit optionsEmployee Assistance ProgramPet InsuranceLegal AssistanceTuition AssistanceConditions 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.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.