Theorem Clinical Research, previously Omnicare Clinical Research, is a leading global, full-service contract research organization (CRO) headquartered in King of Prussia, Pennsylvania. With office locations in 32 countries, we have relationships with customers all across the globe comprised of some of the world’s leading pharmaceutical, biotech and medical device companies. Theorem’s core CRO services are Early Phase, Phase II/III and Late Phase and the company features specialized Business Units focused on medical device, technical services and pharmaceutics. For more information on Theorem, visit us at www.theoremclinical.com.

Job Description

Think Theorem -Think Ahead!

The primary function of a Clinical Research Associate II (CRA II) is to ensure the timely production of high quality clinical data, adhering to the standards set by the Company/Sponsor in the Standard Operating Procedures for clinical studies.

• Identifies potential investigator sites.
• Performs comprehensive site management activities. Provides consultative services to site personnel by coordinating and disseminating all pertinent data regarding study protocols, Case Report Forms, and FDA/ICH GCP guidelines. Helps to define quality standards within the project team.
• Conducts Pre-Study Monitoring visits. Reviews study plans with clinical investigators and evaluates clinical sites to ensure that they meet all study parameters and all FDA and GCP guidelines.
• Conducts Site Initiation visits. Reviews and explains study protocols with clinical investigators and clinical site staff. Serves as consultant to site personnel on all sponsor-related SOPs and regulatory requirements.
• Conducts Interim Monitoring visits. Reviews source documents, CRFs, regulatory documents, Informed Consents, Investigational Product, and clinical supply accountability. Ensures all Adverse Events have been documented and reported according to FDA regulations and sponsor protocols. Provides feedback and training to site personnel as needed.
• Conducts Close-Out visits. Retrieves and reconciles all study supplies. Archives study documentation and prepares the clinical site for any potential audits.
• Produces timely and comprehensive visit and status reports with minimal corrections/rewrites.
• Within International – collection of high quality critical documents and completion of ethics committee and regulatory submissions as applicable.
• Completes all other assignments given by management or as business needs require.

Desired Skills & Experience

• Solid knowledge of ICH-GCP and applicable regulatory guidelines. Solid clinical research and monitoring knowledge base.
• Demonstrated ability to provide consultative services to Investigators and site personnel.
• Good communication skills with ability to relay pertinent information to site personnel and study team.
• Strong organizational skills. Ability to function independently in either a home-office environment or office facility. A proven ability to take initiative and follow-up independently.
• Strong team skills with ability to work effectively with Company Clinical Monitoring Managers, Lead CRAS, Project Managers and Project Directors as well as site personnel.
• Computer literate; Microsoft Office skills including Word, Excel, and Outlook.
• Ability to work independently with minimal supervision.
• Bachelor’s degree from an accredited institution of higher education or RN certificate required. Degree in Life Sciences preferred.
• 2 to 3 years of experience as a field monitor within a work-from-home setting.
• Ability to travel approximately 65 70%
• Fluent in English and Local language. (Written & Oral)

To apply for this job send your resumes to:
[email protected]