Oncology Data Coordinator would be 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.
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 Professional Characteristics:
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
Proficient in Microsoft Office Suite
Projects a professional and positive interaction with internal/external parties with appropriate communication and collaboration.
Proposes, implements, and evaluates appropriate resolutions.
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 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.
About Caris Life Sciences
Caris Life Sciences® is an innovative biotechnology company actively working to fulfil the promise of precision medicine through our unique and transformative platforms to help patients with cancer and other complex diseases. Platforms include:
Caris Molecular Intelligence®
Caris Molecular Intelligence, the company’s patented and proprietary offering, provides oncologists with the most clinically actionable treatment options available to personalize cancer care today.
ADAPT Biotargeting System™
The ADAPT Biotargeting System is an unbiased profiling platform that identifies novel molecular targets to inform and enhance drug development and advanced diagnostics. Currently being developed for cancer and other complex diseases, the ADAPT Biotargeting System has potential applications spanning therapeutic development, drug delivery, diagnostics and disease monitoring.