Clinical Research Associate

We are seeking an experienced Clinical Research Associate (CRA) to monitor clinical trials for device studies. The successful candidate will be responsible for ensuring compliance with regulatory requirements, good clinical practice (GCP), and company standard operating procedures (SOPs). This is an excellent opportunity to join a dynamic team.

Key Responsibilities:

1. Conduct site qualification visits, site initiation visits, interim monitoring visits, and close-out visits to ensure compliance with the clinical trial protocol, regulatory requirements, and company SOPs.
2. Monitor research studies, including reviewing and verifying source data, identifying and addressing data queries, and ensuring data quality and integrity.
3. Develop and maintain relationships with investigative sites, including principal investigators, study coordinators, and other site staff.
4. Identify, assess, and mitigate risks associated with clinical trials, including risk-based monitoring and implementation of corrective and preventive actions (CAPAs).
5. Ensure compliance with regulatory requirements, including FDA regulations, ICH GCP guidelines, and company SOPs.
6. Prepare and review monitoring reports, trip reports, and other documents related to clinical trial monitoring.
7. Collaborate with cross-functional teams, including clinical operations, data management, and regulatory.
8. Stay up-to-date with industry trends, regulatory requirements, and company SOPs.

Requirements:

1. Bachelor's degree in a life science, nursing, or related field.
2. Must have experience with traditional CRA duties such as IMV, SQV, etc.
3. Minimum 5 years of experience in clinical research, preferably in device studies (Project Manager, Clinical Research Coordinator or Clinical Research Assistant)
4. Minimum 2 years of experience as a Clinical Research Associate or Study Monitor
5. Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
6. Strong knowledge of regulatory requirements, including FDA regulations, ICH GCP guidelines, and company SOPs.
7. Knowledge of medical devices and device-related regulations.
8. Excellent communication and interpersonal skills.
9. Ability to travel (up to 80%) to investigative sites.
10. Certification as a CCRA, CCRP, or CPM is preferred.

Nice to Have:

1. Master's degree in a life science, nursing, or related field.

Salary : $55 - $65 per hour