Clinical Research Associate II

An incredible opportunity exists for a skilled Clinical Research Associate to join forces with one of the bay area's premiere biopharmaceutical organizations! This position is available ASAP for the right candidate, and is located in Berkeley, CA.

Job Summary:
The Clinical Research Associate II (CRA II) implements, monitors and completes clinical trials for new products or product modifications in a timely manner and in accordance with federal regulations. The data from these studies support product claims, regulatory submissions and scientific publications. The CRA II works independently as a project team member and as a contact with clinical investigators and their staff. The CRA II represents Clinical Trials and Monitoring on project teams The CRA II may serve on the core or element team and may advise the team on the types of testing that will be required based on their knowledge of the guidance documents. The CRA II may be supervised by either their Manager or a Sr. CRA.


Job Description:
Under the direction of the Manager or, for specific projects, a Sr. CRA, the CRA II assists in devising and writing study protocols, investigator manuals, site specific instruction manuals and designing case report forms for new and modified products. The CRA II is independently responsible for all activities of the clinical trial including: assistance in clinical site selection, study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation. The CRA II is responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.

The CRA II documents all clinical trial information with adherence to FDA requirements and works with support staff to assure that all documents are submitted and successfully executed (e.g., contracts, IRB approvals, financial disclosure agreements) in a timely fashion.

The CRA II may prepare clinical reports and clinical and nonclinical sections of regulatory submissions [PMA, PLA, IDE, 510(k)], and, may in conjunction with their Manager and clinical investigators assist in the preparation of scientific abstracts, posters and publications arising from the trials. The CRA II also provides the team with up-to-date reports on clinical trial progress, based on site monitoring logs, interim data summaries and site contacts.


This is a mid-level position, and entry-level candidates will not be considered for this opening.


Job Requirements:
? Ph.D. in a health related field (public health, microbiology, virology, molecular biology, oncology, biology) with 1 year of clinical trial-related experience, or MS in a health related field with 3 years of clinical trial-related experience or BS in a health related field with 5 years of clinical trial-related experience
? Clinical laboratory or product development experience desired but not required
? Experience in design and conduct of clinical trials.
? Ability to work with opinion leaders in areas of importance to the products under study with initiative and in a highly creative manner.
? Ability to work independently on all aspects of clinical trial design, monitoring, and reporting.
? Ability to handle significant work loads, work effectively with peers in teams.
? Ability to organize and manage multiple projects.
? Excellent written and oral communication skills.
? Computer use skills: spread sheets, word processor, graphics/statistics, presentation packages.


If you feel you are a strong match for this position, please e-mail your resume directly to mary.mellinger@adeccona.com and include "CRA II" in the subject line of the e-mail.

Due to the volume of resumes received, only qualified candidates will be contacted regarding this opportunity.

Unfortunatley, H1-B Visa applicants cannot be considered for this position.

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