Clinical Research and Site Monitoring specialist

Employvision Inc. is seeking a Clinical Research Associate to perform site monitoring and site management for oncology studies. The role supports clinical trial execution by ensuring site compliance, data quality, recruitment, regulatory documentation, and timely resolution of site issues.

Responsibilities

Conduct site selection, site initiation, routine monitoring, and close-out visits in accordance with the study protocol, contracted scope of work, and applicable regulatory requirements

Monitor site performance and ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and local regulations

Partner with investigative sites to develop, implement, and track subject recruitment and enrollment plans

Provide protocol and study-specific training to assigned sites and maintain effective communication throughout the study

Assess the quality and integrity of site practices , identifying protocol deviations, compliance concerns, and other quality issues and escalating them as appropriate

Track key study milestones, including regulatory submissions and approvals, recruitment/enrollment, CRF completion, data queries, and query resolution

Support clinical trial study start-up activities , as required

Ensure required site documentation is collected and maintained within the Trial Master File (TMF)

Verify that the Investigator Site File (ISF) is maintained in compliance with GCP/ICH and local regulatory requirements

Prepare and maintain monitoring documentation, including monitoring visit reports, follow-up letters, action plans, and other study-related documentation

Conduct co-monitoring and training visits and provide mentorship to clinical research staff, as applicable

Collaborate with Clinical Operations and cross-functional study team members to support successful project execution

Support the development and implementation of site-specific recruitment strategies , when applicable

Support site financial management , including tracking clinical trial agreement requirements and processing/retrieving invoices according to local requirements, when applicable

Preferred

Bachelor's degree in a scientific discipline, healthcare, or related field

Equivalent combination of education, training, and relevant experience may be considered in lieu of a degree

Bachelor’s Degree

Scientific Discipline

Healthcare

Relevant Experience

Professional Training

Benefits

Remote work is possible; 100% travel to other states is required for site monitoring.

Company

IT staffing, recruiting, and consulting services

Somerset, New Jersey, USA

http://www.employvision.com/

Founded in 2005

51-200 employees

Qualifications

4+ years of on-site clinical monitoring experience

Strong knowledge of clinical research regulations, GCP, and ICH guidelines

Strong therapeutic-area and protocol knowledge, with the ability to apply study-specific requirements effectively

Proficiency with Microsoft Word, Excel, and PowerPoint

Comfortable working with laptops and mobile devices, including iPhone/iPad, as applicable

Excellent written and verbal communication skills with strong command of English

Strong organizational, analytical, and problem-solving skills

Effective time and financial management capabilities

Ability to build and maintain effective working relationships with investigators, site staff, clinical teams, managers, coworkers, and clients

Bachelor's degree in a scientific discipline, healthcare, or related field

Equivalent combination of education, training, and relevant experience may be considered in lieu of a degree

Required skills

Clinical Site Monitoring, Clinical Research Regulations, Clinical Practice (GCP), ICH Guidelines, Clinical Trial Protocol Knowledge, Microsoft Word, Microsoft Excel, Microsoft PowerPoint

Preferred skills

Written and Verbal Communication

Experience

4+ years