Responsible for managing and monitoring clinical sites to assure compliance with applicable regulatory requirements and Good Clinical Practices. As part of the clinical operations team ensures and works across the project team to ensure site relationships are maintained, clinical data is entered and cleaned and up to date metrics are tracked and relayed to the project team as appropriate.
Overnight travel 20%-80%, anywhere in the U.S.
Assist the clinical team with a variety of study-related activities
Perform remote and on-site monitoring activities per the Clinical Monitoring Plan (CMP)
Conduct or attend Site Initiation Visits (SIVs)
Validate and collect study data for data cleanliness
Manage enrollment issues at the site level, resolution of data queries and site performance
Assist with collection of site study metrics for overall study performance
Audit, manage and collect clinical regulatory documents
Ensure site compliance with regulatory requirements and Good Clinical Practices (GCPs),
and Proxima and client policies and procedures
Conduct study site close-out visits (COVs)
Attendance at company meetings, completion and proper submission of timesheets and
documentation of training
Adherence to Proxima or client Standard Operating Procedures (SOPs) (as applicable)
Professionally represent Proxima in business interactions
At least 3 years experience in sponsor, clinical or CRO environment.
Working knowledge of clinical research industry and requirements for MedTech and/or BioTech industries.
Working knowledge of Good Clinical Practice (GCP) or applicable regional regulations and guidance.
BA, BS or Associate’s degree or equivalent in a scientific or healthcare field or a minimum of 6 months clinical trial experience. Must have a thorough understanding of current GCP, ICH-E6, ISO 14155 and FDA regulations pertaining to clinical research and be able to interpret and implement this understanding. Familiarity with common medical terminology is required. Strong interpersonal skills. Excellent oral and written communication skills. Ability to articulate issues. Self-management skills, including ability to multi-task. Attention to detail and accuracy in work. Strong problem solving and interpersonal skills. Excel, Word, timeline management and computer skills (proficiency using Microsoft Office or similar). Ability to maintain and implement confidentiality on behalf of Proxima Clinical Research and its clients.