Clinical Research Associate (CRA)
Company: SciQuus Oncology
Position: Clinical Research Associate (CRA)
Overview: The Clinical Research Associate (CRA) plays a vital role in the execution and monitoring of clinical trials. This individual ensures that the conduct of clinical studies is in compliance with the approved protocol and applicable regulations, ensuring the safety and rights of participants and the quality of the data collected.
Key Responsibilities:
- Site Monitoring: Conduct site visits, including initiation, monitoring, and close-out, to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory requirements.
- Data Verification: Review and verify accuracy of patient data, case report forms (CRFs), and other clinical documents.
- Training: Train site staff on study protocol, data collection procedures, and other relevant study-specific processes.
- Report Writing: Prepare detailed monitoring reports and follow-up letters after each site visit.
- Issue Resolution: Identify, report, and assist in resolving any potential issues or discrepancies observed during site visits.
- Collaboration: Work closely with the clinical trial team, including data managers, medical monitors, and project managers, to ensure smooth execution of trials.
- Regulatory Adherence: Ensure that all study-related documentation and activities adhere to the necessary guidelines, including GCP and FDA regulations.
Qualifications:
- Bachelor’s degree in a related field (life sciences, nursing, or pharmacy).
- Previous experience as a CRA or in a similar clinical research role, preferably in oncology.
- Strong knowledge of GCP and relevant regulatory guidelines.
- Proficient in clinical data review and verification.
- Excellent organizational, communication, and interpersonal skills.
- Ability to travel frequently for site visits.
As a Clinical Research Associate (CRA) at SciQuus Oncology, you will be instrumental in advancing clinical research studies, ensuring that they are conducted with utmost integrity and precision. Your meticulous oversight will directly influence the organization’s commitment to improving outcomes for individuals with cancer.