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 Study Manager/Director by independently performing assigned clinical operations tasks from study start-up through study execution and closeout.

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

Assist in the planning, organizing and executing project-specific meetings

Participate in vendor management/oversight

Develop and maintain/oversee study tracking reports and study tools

Track enrollment and follow up on outstanding information

Oversee study tracking to ensure documents are accurate, current and complete

Assist with resolution and communication of investigational site Protocol Deviation Forms

Assist with overseeing tasks performed by Clinical Trial Assistant(s)

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

Perform additional tasks and duties as assigned

QUALIFICATIONS:

Must have excellent organizational skills and be detail-oriented. Able to work independently and to function as a team player. Able to manage/prioritize own work. Must have excellent interpersonal skills and excellent communication skills (verbal and written). Knowledge of FDA regulations, Good Clinical Practices, and ICH Guidelines necessary. Computer proficiency required.

EDUCATION and EXPERIENCE:

BA or BS degree preferred

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

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