CRA III (32859)

Company Name:
Prepare and independently performs study site qualification, initiation, interim monitoring, and close-out visits at the clinical investigative sites to ensure adherence to protocol, procedures, and project plans in accordance with FDA regulations. Maintain site files, trial master files and study documentation. Activities and oversight to support the operational execution of clinical trial procedures, ensuring high quality, accuracy and integrity of data reported. May be on-site or field based.
DUTIES: Manage the study conduct of assigned clinical sites and studies; including acting as liaison to clinical investigators, ensuring the quality and integrity of data. Monitor clinical trials activities at the site-level; following established standard operating procedures, good clinical practices and regulatory requirements. Assist investigators and staff to quickly and effectively resolve issues. Responds to problems and assists. Maintains regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual rates, and responds to site/department requests, and documents all pertinent communications. At the investigation site, track clinical trial supplies, patient recruitment activities, and Serious Adverse Events, review Case Report Forms for accuracy and completeness and conduct query resolution. Assist in identifying investigator sites for participation in trials. May attend procedures involving study participants in order to support study protocol data collection. Among other activities may assists in the review of protocols, informed consents and case report forms. Participates as needed in planning and conduct of Investigator meetings, including giving presentations to peers and study site personnel. Assists in developing Monitoring plans, Assists in the maintenance of Trial Master File (TMF). Assists in the collection and maintenance of study data and collateral materials for reports to senior management and regulatory authorities. This may include reviewing clinical documents and reports, reviewing data listings, participating in the completion of medical writing assignments and performing quality control reviews. Performs literature searches. Assist in developing monitoring guidelines and other assorted project-specific resources and training materials.
SKILLS: Excellent written and oral communication skills. Knowledge of Microsoft Office applications. Excellent interpersonal skills, great understanding of team-culture. Demonstrate a nature of proactively, enthusiasm, independent drive, and energetic outlook to tasks. Exceptional organizational skills, Works towards and meets deadlines. Ability to collaborate, build strong partnerships/relationships with all stakeholders.
Min Salary: $0.00
Max Salary: $0.00
City: Raritan
State: NJ

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