Clinical Research Associate CRA - B

Client: Medical Device

Job Title: Clinical Research Associate

Location: Alameda CA

Duration: 06 Months

Responsibilities:

The CRAII/Sr. CRA will assist in the clinical execution and management of all aspects of assigned clinical studies. This includes but not limited to planning and implementation of clinical studies from concept to

clinical study report per timelines and quality standards.

Essential Duties and Responsibilities

The incumbent may be asked to perform other functionrelated activities in addition to the below mentioned responsibilities as reasonably required by business needs.

Conduct single or multicenter medical device clinical studies.

Perform study site visits (SQV SIV IMV COV) generate monitoring trip reports and track resolution of action items.

Participate in study start up activities.

Responsible for shipping study devices and supplies to clinical sites and performing study device accountability.

Manage clinical monitoring activities and overall site management ensuring compliance to the Study Protocol Good Clinical Practices (GCPs) ICH guidelines Federal Regulations department procedures and applicable regulatory requirements.

Responsible for assisting senior staff in planning study conduct designing case report forms (CRFs) conducting User Acceptance Testing (UAT) Contract Research Organization (CRO) selection and management selection and training of investigator sites planning and running study meetings evaluation selection and training of new study investigators and writing and assembling submissions.

Maintain and audit Trial Master File to ensure inspection readiness.

Perform review of clinical data listings for completeness and accuracy and escalate issues to the Clinical Operations Manager as needed

Participate in crossfunctional clinical team(s) in the planning and execution of clinical trials.

Proactively and effectively communicate the status of clinical studies to management.

Ensures quality delivery of study deliverables within agreed budgets and timelines.

Participate in the interim and final reviews of study data in preparation of regulatory submissions.

Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF) Clinical Protocols and Reports).

May interact with RA/QA in responding to audits and FDA inquiries.