Clinical Research Associate

Job Description

The Clinical Research Associate will provide overall support to study sites and clinical project teams involved in clinical research studies. Responsibilities include: - Adhering to applicable protocols, SOPs, guidelines, and regulatory requirements. - Acting as a point of contact for study sites. - Overseeing study site management to ensure patient safety and data quality. - Providing guidance on audit readiness standards and supporting audit preparation. - Updating and maintaining study-specific trial management tools and status reports. - Managing site start-up procedures, including feasibility and investigator recruitment. - Assisting in the negotiation of study budgets and the execution of investigator contracts. - Verifying the informed consent process for each subject/patient. - Independently conducting site visits, including pre-study, initiation, monitoring, and close-out visits. - Documenting activities via confirmation letters, trip reports, and communication logs. - Routinely reviewing the Investigator Site File for accuracy and completeness. - Communicating effectively with site personnel and Precision Project and Clinical Trial Management. - Developing and maintaining good relationships with investigators and study staff. - Performing investigational product inventory, reconciliation, and reviews of storage and security. - Performing data review activities, including remote EDC CRF and patient profiles review, query resolution. - Identifying and processing Serious Adverse Events according to study procedures. - Identifying site risks and escalating them to the Clinical Trial Manager/Project Manager. - Preparing for and attending Investigator Meetings and sponsor face-to-face meetings. - Traveling as necessary according to project needs. - Performing other duties as assigned.

Qualifications

1. Bachelor's degree or equivalent in a business, scientific, or healthcare discipline. 2. Minimum of 2 years of on-site monitoring experience; 1 year of oncology trial experience preferred. 3. High proficiency in Microsoft Office programs (Outlook, Word, Excel, and PowerPoint). 4. Customer service-oriented with flexibility and teamwork skills. 5. Ability to focus on detail and maintain accuracy. 6. Fluency in English communication, both verbally and in writing. 7. Working knowledge of the drug development process. 8. Willingness to travel (60-70%).

Benefits

- Competitive salary - Flexible working hours - Professional development budget - Home office setup allowance - Global team events