Clinical Study Coordinator

Company: Connect Life Sciences
Location: Plano
Posted on: May 15, 2022

Job Description:

Job Description The Clinical Study Coordinator (CSC) performs assigned clinical study-related activities under the supervision of the Principal Investigators at designated study sites. The CRC assists with patient medical record data abstraction, eCRF completion/data entry, query resolution, and maintenance of regulatory documentation. The CRC and is responsible for ensuring these activities are performed in compliance with ICH GCP guidelines and applicable regulatory requirements. Roles and Responsibilities The CSC is responsible for:

• Abstracting data from electronic patient medical records.
• Completing electronic case report forms (eCRFs) and resolving queries.
• Fulfilling sponsor requirements related to reportable information as defined in the study protocol, including adverse events and unanticipated problems.
• Responding to any written requests for data clarification from the sponsor.
• Organizing and maintaining all necessary source documents.
• Ensuring source and regulatory document accuracy by following good documentation practices.
• Obtaining data, including medical records and images, from outside facilities as needed.
• Meeting contractual or institutional requirements for timeliness of data entry and query resolution
• Participating in required teleconferences with the study team and the sponsor, both on-site and off-site, as required.
• Identifying and communicating important protocol and data management issues or problems to the Principal Investigator and sponsor in a timely manner.
• Ensuring required study site regulatory documentation is complete and up to date.
• Other duties as assigned Qualifications• Associates Degree in science or related field required.• At least two years of experience related to the conduct of clinical studies.Core Competencies, Skills, and Experience RequirementsSurgical Innovation Associates
• Working knowledge of ICH GCP Guidelines; Federal, State, and Local Regulations; and IRB requirements.
• Experience related to the conduct of clinical studies is required; experience related to device clinical studies is preferred.Experience with electronic medical record (EMR) systems. Experience with web-based Electronic Data Capture (EDC) systems. Proficiency in time management, prioritization, and multi-tasking required.Ability to complete tasks independently, strong verbal and written communication skills, organizational and critical judgment skillsAbility to interact effectively with clinicians, study staff, and the study sponsor. Strong attention to detail.Must be able to read, interpret, and process large quantities of printed information. Travel: Travel via automobile or commercial aircraft will be required 75-100% of the time to support clinical study.

Keywords: Connect Life Sciences, Plano , Clinical Study Coordinator, Healthcare , Plano, Texas