Contract Cra Jobs

: Clinical Research Associate (Monitor) - Contract Position

Position Summary:

The Clinical Research Associate (CRA), also known as a monitor, is responsible for ensuring that clinical trials are conducted in accordance with applicable regulations, protocols, and good clinical practices (GCP). As a contract CRA, you will work on a project-specific basis, collaborating with various stakeholders to monitor and oversee the progress of clinical trials.

Key Responsibilities:

1. Site Monitoring: Conduct routine site visits to monitor the progress of clinical trials, ensuring adherence to study protocols, regulations, and GCP. This includes source data verification, reviewing regulatory documents, and assessing the overall integrity of the trial.
2. Trial Documentation: Assist in the development and review of essential trial documentation, such as study protocols, informed consent forms, case report forms (CRFs), and other relevant documents as required.
3. Investigator Training: Provide training and guidance to investigators and site staff on study protocols, procedures, and compliance requirements.
4. Data Collection and Reporting: Monitor and collect data from clinical trial sites, ensuring accuracy, completeness, and timely reporting. Collaborate with data management teams to resolve data queries and discrepancies.
5. Safety Oversight: Monitor and report adverse events, protocol deviations, and serious breaches to the appropriate authorities, ensuring patient safety and regulatory compliance.
6. Regulatory Compliance: Ensure compliance with local regulatory requirements, industry standards, and study-specific guidelines. Assist with submissions to ethics committees and regulatory bodies, as necessary.
7. Study Coordination: Collaborate with cross-functional teams, including project managers, investigators, study coordinators, and clinical research organizations (CROs), to ensure efficient study conduct and completion.
8. Quality Assurance: Participate in quality assurance activities, including audits, to ensure adherence to standard operating procedures (SOPs) and regulatory requirements.
9. Data Management Support: Support data management activities, such as data cleaning, validation, and database lock, in collaboration with data management teams.