Note: The job is a remote job and is open to candidates in USA. Zachary Piper Solutions is seeking an experienced Clinical Research Associate (CRA) to join their client’s team in the Oncology Clinical Research field. The CRA will monitor and manage clinical trials, ensuring compliance with regulations and maintaining high standards of data integrity and patient safety.
Responsibilities
- Monitor clinical trials to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines
- Conduct site visits, including pre-study, initiation, monitoring, and close-out visits
- Review and verify case report forms (CRFs) and source documents for accuracy and completeness
- Ensure timely and accurate reporting of adverse events and protocol deviations
- Provide training and support to site staff on study protocols, procedures, and regulatory requirements
- Maintain effective communication with study sites, investigators, and other stakeholders
- Assist in the preparation and review of study-related documentation, including informed consent forms, study manuals, and monitoring plans
- Participate in study team meetings and provide updates on site status and study progress
Skills
- At least 3 years of experience as an On-site CRA
- Comfortable with up to 70% travel (2-3 days per week)
- Must have a valid driver's license
- Must be comfortable handling questions regarding RECIST (Response Evaluation Criteria in Solid Tumors) and CTCAE (Common Terminology Criteria for Adverse Events)
- Strong understanding of clinical trial processes and regulatory requirements
- Excellent organizational and time management skills
- Strong communication and interpersonal skills
- Ability to work independently and as part of a team
- Bachelor's degree in a related field (e.g., life sciences, nursing, pharmacy)
Benefits
- Medical
- Dental
- Vision
- 401K
- PTO
- Sick Leave as required by law
- Holidays
Company Overview
Company H1B Sponsorship