Clinical Study Coordinator
Company: Connect Life Sciences
Posted on: May 15, 2022
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
- 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
- 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
- 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
Keywords: Connect Life Sciences, Plano , Clinical Study Coordinator, Healthcare , Plano, Texas
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