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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 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.

• 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.

• Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening and reference verification.

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 evening work.

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.

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