Clinical Data Coordinator I

Caris Life Sciences; Massachusetts; Sur place; USD 70 000 - 110 000; Plein temps

Résumé du poste

Caris Life Sciences in Massachusetts is seeking a Clinical Data Coordinator to manage data entry for oncology protocols across participating sites. You will ensure high data quality and timely responses to data queries.

Responsibilities include abstracting data from source documentation, entering into EDC case report forms, and performing quality checks in alignment with GCP, FDA, IRB, and HIPAA requirements. Some travel may be required.

Qualifications

• 3–5 years of experience in data collection within a GCP/clinical research environment.
• Knowledge of GCP/ICH/ CFR.
• Clinical study experience in oncology.
• Strong medical terminology understanding.
• Experience planning and reporting large projects.
• Experience training staff and mentoring.
• Experience with EDC systems.
• Proficient in MS Office (Word, Excel, Outlook).

Responsabilités

• Abstract clinical data from source documentation.
• Enter data into study-specific EDC CRFs.
• Clean data to verify accuracy.
• Update the EDC after data verification and resolve queries.
• Track site goals and CRF completion.
• Prioritize site cases for analysis.
• Maintain study documentation.
• Perform QC audits of the database.
• Adhere to GCP, FDA, IRB, HIPAA and SOPs.
• Travel to investigative sites as needed.

Connaissances

Data collection

EDC systems

GCP/ICH/FDA

Oncology trials

Medical terminology

Communication

Project planning

Training/mentorship

Microsoft Office

Outils

EDC systems

Description du poste

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 Summary

The 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 Responsibilities

• Abstract 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 Qualifications

• Position 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 Demands

• Must possess ability to sit and/or stand for long periods of time.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• This position may require occasional evenings and overtime.

Conditions 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.

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.

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