Clinical Trial Project Manager
1 week ago
Joulé is seeking a highly skilled Clinical Trial Coordinator to join our team.
About the Role:As a Clinical Trial Coordinator, you will be responsible for ensuring the smooth execution of clinical trials. Your primary goal will be to maintain accurate and up-to-date records, while collaborating with cross-functional teams to achieve trial objectives.
About the Responsibilities:- Review source documents submitted by investigative sites for potential endpoint events to ensure documents were uploaded to the correct event in the electronic adjudication system (EAS).
- Provide a hyperlink to client's secure file transfer protocol (sFTP) to investigative site personnel for source document transfer if the EAS is unavailable, not being used for the trial, or site personnel do not have access.
- Enter and track events and event statuses for trials not utilizing electronic adjudication into an Excel database.
- Submit documents to the designated translation vendor for translation into English and enter the submission into the translation tracker as directed.
- Perform a quality review of translated documents to ensure PII has been completely redacted by the vendor. Notify the CEC Lead Coordinator or Sr. Project Manager of redaction oversights. Track, and redact the information following trial-specific conventions.
- Compile the event dossier consisting of submitted source documents and the patient profile report downloaded from the designated location provided by the pharmaceutical sponsor/sponsor vendor.
- Advance events through the adjudication workflow following trial-specific procedures.
- Submit events to the assigned Medical Reviewer (MR) and process any queries to the investigative sites following trial-specific procedures.
- Utilize the adjudication system's audit trails to identify changes made to events before and after adjudication.
- Participate in system validation by performing user acceptance testing (UAT) pre-system go-live and for system changes for the trial's duration.
- Bachelor's degree
- Proficiency in MS Office products (Outlook, Word, Excel, and PowerPoint) and familiarity with databases
- Possess strong interpersonal skills to effectively communicate with cross-functional teams including staff at all levels of the organization
- Ability to successfully negotiate and collaborate with others of different skill sets, backgrounds, and levels within and external to the organization
- Strong problem-solving and negotiation skills
- Requires minimal direction from leadership and possesses the ability to learn quickly
The estimated salary for this role is $65,000 - $80,000 per year, depending on experience and qualifications.
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