Clinical Research Associate
Proclinical is working with a leading medical device company in search for a remote Clinical Research Associate. As the Research Associate, you will oversee and support the conduct of clinical studies, with a primary focus on the conduct of on-site and remote clinical site monitoring and centralized data review.
- Conduct site visits (SQV, IMV, COV) as required per Monitoring Plan to perform source data/document verification
- Conduct centralized data review activities to identify potential outliers and discrepancies and communicate with sites to resolve data discrepancies and queries
- Identify and assess suitability of clinical study sites and investigators
- Clinical study product and material accountability
- Close out clinical study sites on completion of the study
- Prepare site subject binders, study visit documents and PowerPoint presentations
- Maintain study requirements for posting to clinicaltrials.gov
- Maintain and update clinical study management systems as needed
- Maintain completeness of site documents in trial master file
- Able to assist in the creation and maintenance of the study annual budget
- Able to create and edit a study report (annual or ad hoc) as needed
- Assist other team member participating in the cross-training opportunities with study-related activities
- Works with team members to identify process improvements
- Participate in regional and global process improvement initiatives
- Maintain standard operating procedures
- Actively participates in departmental and business unit meetings and scheduled activities
- Willing to assist and mentor other team members
- Ability to effectively identify and resolve conflicts and disagreements regarding clinical research matters
- Impacts project teams and business units through quality work and leadership of projects or portions of projects
Skills and Requirements:
- Bachelor's Degree (or non-US equivalent), required. Concentration in nursing, life sciences, engineering or other medical sciences preferred
- A minimum of 3 years of applicable experience required, including a minimum of 1 year of field monitoring experience
- Established knowledge of Good Clinical Practice (GCP) and local government-related guidelines and regulations
- Clinical Research Professional certification is preferred
- A combination of education and experience may be considered
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 267-297-3376 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.