CLINICAL RESEARCH ASSOCIATES

An international pharmaceutical company offers full-service clinical research capabilities across all therapeutic areas. Coupled with our customer-centric focus, we provide clients with exceptional service throughout all phases of drug development. Our global, integrated network of 30 offices with a presence in 27 countries provides convenient access to expertise and patients around the world.

We are currently seeking Senior CRAs to work from home across the United States. Responsibilities for this position include:

? Coordinate and perform comprehensive site management on one or more clinical protocols including telephone contacts, and conduct and documentation of pre-study, initiation, interim and closeout site visits or by participating in coordinating center activities.

? Ensure completion and accuracy of Omnicare Clinical Research/Sponsor project specific tracking requirements including patient enrollment, grant payments and data clarification requests (DCR).

? Coordinate and disseminate information to site staff regarding study protocol, CRFs and FDA/ICH GCPs. Assures adherence to protocols, amendments, governmental regulatory guidelines, and client related conventions.

? Monitor study protocols, including review of source documents, case report forms, regulatory documents, informed consents, investigational product, clinical supply accountability, AE/SAE reporting, and transmittal of CRFs.

? Ensure immediate reporting of any serious adverse events related to the study project.

? Complete all study related and administrative reports and documents as required. Provide documentation of follow-up of outstanding issues and documents.

? Training and development of less experienced/newly hired CRAs or delivery of project specific training.

? Participation in study wide projects including assisting with the development of the clinical monitoring plan, study wide tracking initiatives, development of project specific worksheets, etc.

? Participate in project and/or departmental related presentations (Investigator Meeting, client presentation, CRA monthly teleconference, etc.)

Qualifications:

? 4 year degree,. or equivalent.

? 3 years monitoring experience; experience monitoring both out-patient and in-patient studies preferred.

? Knowledge of Word, Excel and Windows.

? Working knowledge of FDA/ICH GCPs, and Canadian HPB regulations.

? Attention to detail and highly organized. Ability to work independently.

? Presentation and training skills.