Clinical Data Coordinator at Kelly
Clinical Data Coordinator – Remote
Rye Brook NY, USA
Work from Home
Job Reference : US4364AG_BH3813203
Work Type: Full Time
Employment Type: Temporary
Career Level: Experienced (Non-Manager)
Shift First Shift (Day)
Job Category Scientific
Willing to Travel None
Job Industry Biotechnology/Pharmaceuticals
Work from Home Yes
Clinical Data Coordinator
1 year Contract (extendable)
The Clinical Data Coordinator would be responsible for clinical data entry activities for the protocols and projects as directed. 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.
- Responsible for the abstraction, entry, and general management of study data for clinical trials.
- Assists with collection, entering, cleaning, maintenance and reporting of clinical research data
- Enters protocol, medical history, and demographic information abstracted from patient charts into appropriate data capturing system (EDC)
- Follow protocol design to assure all protocol data elements are collected in accordance with protocol guidelines
- Update the EDC following verification of subject data, including the resolution of data queries
- Track site goals and case report form completion.
- 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.
- Maintain company and Site requirements for source document management and request for information.
- Communicate effectively with the research team, investigator(s), Clinical Research Associate(s), study sponsor and ancillary staff.
- Position requires 3+ years of experience in data collection activities within a GCP/clinical research regulatory environment.
- Education: High School required, some college preferred
- Knowledgeable in critical elements for success in clinical trials. GCPs, ICH, and Code of Federal Regulations.
- Clinical study experience in Oncology preferred.
- Strong medical terminology understanding.
- Experience with EDC systems.
- Proficient in Microsoft Office Suite