Sr. Medical Reviewer

12 hours ago

Roxbury Crossing, United States Joulé Full time

Title: Sr. Medical Reviewer

The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.
Location: Remote with scheduled travel into Boston MA
Schedule: Monday thru Friday 8-5pm est (over time as needed to meet deadlines)
Duration: 12 months contracting

Education:
MBBS or RN (licensed in MA) or Physician Assistant (licensed MA)

Requirements:
Minimum 3 years of cardiovascular clinical and/or research experience including clinical endpoints or pharmacovigilance
Provide a medical review of event-specific dossiers to ensure completeness of the data to allow for adjudication by the physician adjudicators.
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
Requires minimal direction from leadership and possesses the ability to learn quickly

Responsibilities:
Review event-specific dossiers to ensure completeness of the data to allow for adjudication by the physician adjudicators.
Identify unredacted personally identifiable information and potential treatment unblinding information in the source and electronic case report form (eCRF) data provided. Notify the CEC Coordinators to redact any such information if identified.
Review data changes and additional documents submitted for previously adjudicated events to determine if re-adjudication is required.
Issue queries to the investigative sites for additional information or clarification of information provided.
Participate in the trial-specific quality control (QC) process by reviewing discrepancies for summarizing and reporting to the CEC Chairman.
Collaborate with the Sr. Project Manager and CEC Director to design the specifications for consistency/logic checks of the adjudication data, review outputs of the checks, and determine appropriate actions based on findings.
Collaborate in the development of trial-specific procedures and work instructions and CEC standard operating procedures (SOPs).
Serve as a resource for client's internal staff, Sponsor trial team members, Clinical Research Coordinators (CRCs), and trial Clinical Research Associates (CRAs) regarding the submission of source documents for CEC events.

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