Regional Clinical Research Associate

Senior Clinical Research Associate Responsibilities include:

- Monitor assigned investigative sites ·

- Conduct pre-study, initiation, interim monitoring and close-out visits ·

- Train assigned investigative sites in GCP and ensure these sites are conducting research according to protocol and     Federal (GCP) regulations ·

- Review investigative sites’ regulatory documentation and ensure compliance with GCP ·

- Monitor informed consent process ·

- Serve as main point of contact with assigned investigative sites ·

- Review and update clinical files at the assigned investigative sites ·

- Initiate actions to ensure all assigned investigative sites are in compliance with protocol and GCP ·

- Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of what happened to a subject while participating in the study ·

- Create and properly file trip reports, follow-up letters and telephone contacts for assigned investigative sites

- Evaluate and Resolve Data Queries ·

- Evaluate study query trends and interact with Study Team in improving data quality ·

- Assist investigative sites with timely and accurate resolution of queries

- Attend, participate and present at Investigator Meetings .

- Effectively negotiate and manage clinical study budgets for assigned sites.

- Act as a liaison between company and assigned investigative sites.      Identify new investigators for future studies.

- Mentor new CRAs .

- Function as Lead CRA for assigned projects: ·

- Develop protocol-specific monitoring tools ·

- Participate in study team meetings ·

- Assist in the development of the study Monitoring Plan and Study-specific monitoring report templates ·

- Review draft CRF and provide feedback as required

- Co-monitor with CRAs from CROs for assigned projects, as needed.

- Up to approximately 75% domestic airline travel required, including some overnight stays.

- Comply with corporate travel policy

Experience and Skills:

Skills/Knowledge Required:

Prior experience as a Clinical Research Associate ·        Must have demonstrated problem-solving abilities in overseeing clinical sites, and demonstrated tactfulness and diplomacy in dealing with study coordinators and physicians ·        Able to resolve routine issues independently ·        Knowledge of regulatory environment (FDA, ICH, GCP) ·        Excellent written and oral communication skills ·        Working knowledge of SOPs relevant to clinical research Ability to drive an automobile and have a valid driver’s license

PREREQUISITES: BA/BS or RN degree; 4+ years of direct clinical study monitoring experience

Additional Information:

Job Level:   Mid Career (2+ years)
Number of Openings:   2

Years of Experience:   At least 2 Years
Level of Education:   BA/BS

Salary:   TBD
Starting Date :   TBD

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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.

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