Clinical Research Associate II
Clinical Research Associate IIRaritan, NJ
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Category:Scientific & Clinical
Joule, a System One division is seeking a Clinical Research Associate II for a contract position. With more than 6,000 employees and roughly 40 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
The Clinical Research Associate II will:
Performs study tracking to ensure that all study files and documents are accurate, current and complete
Performs essential document collection, review, maintenance, and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs.
Provides general support to the Lead CRA in order to manage the investigator sites and ensure compliance
Performs recruitment plan review and provides regular enrollment updates
Addresses protocol questions and issues from investigational sites visits
Performs regular reviews of data according to data review/monitoring guidelines
Assists with resolution of investigational site/data queries.
Confirms and track that all key site personnel have project specific training.
Documents site and sponsor contact and study interactions in a timely and professional manner.
Provides assessment of sample status
Monitors tracking systems (CTMS, TMF, etc.)
Bachelor’s degree, in biological sciences or healthcare
5 years clinical trial experience (CRO, healthcare settings and industry experience are acceptable).
Excellent verbal and written communications skills; excellent interpersonal and organizational skills with demonstrated attention to detail.
Strong computer proficiency in MS Office including Word, Excel, and PowerPoint.
Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
Excellent organizational and record-keeping skills.
Ability to maintain excellent working relationships with a broad range of trial staff.
Knowledge of GCP as relates to clinical trial management
Ability to work well in a team environment but also independently without significant oversight.
Flexibility in work hours and readiness to travel.
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