Research Associate Manager

Clinical Research Associate - Site Management and Monitoring

As a Clinical Research Associate, you will be responsible for ensuring the successful execution of clinical trials. This includes performing monitoring and site management work to guarantee that sites are conducting studies and reporting data as required by the study protocol, regulations, and sponsor requirements.

1. Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements.
2. Work with sites to adapt and drive subject recruitment plans to enhance predictability.
3. Administer protocol and related study training to assigned sites and establish regular communication lines to manage ongoing project expectations and issues.
4. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
5. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution.

You will also ensure copies or originals of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.

• High School Diploma or equivalent degree in a scientific discipline or healthcare preferred.
• At least 1 year of on-site monitoring experience.
• Good knowledge of and skill in applying applicable clinical research regulatory requirements.
• Therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in Microsoft Word, Excel, and PowerPoint.
• Written and verbal communication skills.
• Organizational and problem-solving skills.
• Effective time and financial management skills.

We offer a dynamic and supportive work environment, opportunities for professional growth, and a competitive compensation package.

As a member of our team, you will have access to state-of-the-art technology, resources, and training to help you succeed in your role.

Join us in shaping the future of clinical research and making a meaningful difference in patients' lives.