Clinical Operations Associate

SUMMARY:

Under general guidance, provide support to the clinical team in all aspects of clinical trial operations

ESSENTIAL DUTIES AND RESPONSIBILITIES  include, but are not limited to:

Support clinical trials vendor management and oversight across multiple studies and programs by performing assigned clinical operations tasks from study start-up through study execution and closeout

Contribute to both internal study team meetings and vendor meetings by providing study updates and writing meeting minutes

Assist in the planning, organizing and executing of program and study specific clinical trial documents and team training materials while ensuring consistency across programs

Assist in the planning and execution of Investigator Meetings

Review or develop vendor related scopes of work, site tools, web-based applications, instruction manuals, and identify updates as needed during study conduct

Oversee and maintain study tracking reports of sample management, site equipment, rater training and vendor data corrections/transfers (as related to study safety and efficacy assessments) and follow up on outstanding information

Assist in review of CTOs and protocols as related to vendor feasibility and consistency

Collect, maintain and submit vendor related documentation to Central Files

Establish collaborative relationships with colleagues in Clinical Development, Regulatory Affairs, Quality Assurance and throughout the Company

Perform additional tasks and duties as assigne

QUALIFICATIONS:

Must have excellent organizational skills and be detail-oriented.  Must have strong computer proficiency and software experience particularly with Microsoft Excel.  Able to work independently and function as a team player.  Able to manage/prioritize work deliverables within provided timelines.  Must have excellent interpersonal skills and communication skills (verbal and written).  Knowledge of FDA regulations, Good Clinical Practices, and ICH Guidelines necessary.

EDUCATION and EXPERIENCE:

BA or BS degree preferred

3-5 years of clinical trial experience working at a biotech/pharmaceutical company or CRO

Apply Online