Note: The job is a remote job and is open to candidates in USA. Perspective Therapeutics is a company specializing in oncology, seeking a Clinical Research Associate II (CRA II) to manage and execute clinical trials. The role involves ensuring compliance with protocols and regulatory requirements while collaborating with cross-functional teams throughout the clinical trial process.
Responsibilities
- Participate in study feasibility assessments, and site selection processes
- Assist in the preparation and review of essential documents such as informed consent forms (ICFs) and study manuals
- Conduct site qualification, site initiation, interim monitoring, and close-out visits to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory guidelines
- Regularly review Investigator Site Files (ISF) to assist in maintaining site audit readiness
- Perform routine site communication, including resolving site issues and providing protocol training as necessary
- Contribute to development and delivery of CRA training materials
- Mentor and support junior CRAs and newly onboarded CRAs
- Review study documents including the Clinical Monitoring Plan and Investigator Site File documents
- Participate in trial risk management meetings and procedures
- Identify, develop and implement process improvement initiatives to enhance monitoring quality and mitigate trial risks
- Monitor and review clinical data to ensure accuracy, completeness, and timeliness
- Work closely with data management teams to resolve data discrepancies and ensure data integrity throughout the trial
- Assist in the preparation of regulatory submissions and support inspections/audits as needed
- Ensure that all clinical trial activities are conducted in accordance with applicable regulatory requirements and internal procedures
- Foster strong relationships with investigators, study coordinators, and other key stakeholders
- Provide regular updates to internal teams and management regarding study progress, issues, and resolutions
Skills
- Bachelor's degree in life sciences or a related field
- Minimum 2 years oncology experience (or commensurate)
- Proficiency in understanding clinical trial protocols, GCP, regulatory requirements, EDC, EMR, eTMF, and CTMS
- Strong organizational skills with attention to detail and the ability to prioritize tasks effectively
- Ability to effectively and efficiently perform source data verification (SDV) whether remotely or onsite
- Ability to identify protocol deviations and effectively identify root cause and assist sites in implementing corrective or preventative actions
- Excellent communication and interpersonal skills, both written and verbal
- Ability to travel domestically and internationally as required. Typical CRA travel is up to 50%, however, at times can go up to 75% for certain project deliverables (e.g. database lock, etc.)
- Ability to perform the CRA role without significant onboarding or training
- Can manage complex protocols/sites
- Grows to lead other CRAs
- Advanced degree (e.g., Master's, PhD)
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