At ProClinical, we are seeking a proactive and experienced candidate to fill the role of Senior Clinical Research Associate, based remotely in the United States. The successful individual will be responsible for the coordination of Site Monitors (CRAs) within a project team and site management activities associated with the conduct of clinical research studies under direction of the Project Manager and in compliance with ICH/GCP, SOPs, and the Monitoring Plan.
- Perform and coordinate site management activities including but not limited to site qualification visits, site initiation visits, site training, site routine monitoring visits, and site closeout visits.
- Primary point of contact for Site Monitors working on a study.
- Coordinate site monitor activities in partnership with the Project Manager.
- Provide qualified training and coaching for monitoring teams with regard to the protocol, CRF, and study specific procedures.
- Supports project management in the development and review of study related documents and study tools and revise as necessary if/when protocol is amended
- Ensure that study information from the PM and Sponsor is conveyed to the study team (CRAs).
- Ensure that the team adheres to timelines.
- Assist Project Manager and Quality team to ensure quality of field monitoring.
- Review site visit reports and letters generated by Site Monitors for timeliness, quality, consistency, and appropriate documentation and resolution of issues.
- Provide site related metrics to the Project Manager.
- Prepare for and attend project team meetings and sponsor calls.
- Provide support on budget and timelines and vendor oversight.
- Assist with responses to Quality Assurance Audits.
- Develop or assist with development of Monitoring Plans.
- Provide performance feedback for Site Monitors assigned to a project.
Skills And Qualifications
- BA (allied health fields preferred) and 6-8 years of related experience (4 of which direct management of site performance). 12+ months of site monitoring experience required.
- Demonstrated ability to work independently and collaboratively with partners and peers on cross-functional teams
- Up to date knowledge of GCP/ICH Guidelines.
- Strong proficiency in Microsoft Office.
- Knowledge of ICH/GCP and applicable regulatory requirements.
- Experience with training and mentoring CRAs.
- Good understanding of the drug development process.
- Excellent written, verbal, and interpersonal communication skills.
- Ability to travel up to 25%.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mary Jacobs at (+1) 2674774800 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.