26 may
|
Syneos Health
|
Buenos Aires
26 may
Syneos Health
Buenos Aires
Postúlate en Kit Empleo: kitempleo.com.ar/empleo/q2jvs
Endpoint Adjudication Specialist, great opportunity for Study Coordinators in BA/Argentina
Job Responsibilities
- Perform responsibilities for the establishment of a clinical trial committee which may include:
- Identify potential members to serve on trial committees.
- Collect potential and selected committee member documents i.e. NDAs, CVs, etc., and perform initial assessments i.e. debarment checks, conflict of interest attestation, etc.
- Manage the negotiation and execution of contractual agreements.
- Receive, submit and track committee member invoices against the project budget and member contracted services.
- Perform responsibilities as per Committee Charter and applicable project plan(s) which may include:
- Schedule and attend committee meetings.
- Prepare and/or distribute committee meeting materials: agendas, meeting minutes, etc.
and document and track meeting action items.
- Distribute safety listings, expedited safety reports, protocol and other relevant trial documents to committee members for review.
- Review clinical event/endpoint documentation to ensure completeness of adjudication package, appropriate redaction of Protected Health Information (PHI) and to identify any potential unreported clinical endpoints or events requiring adjudication.
- Initiate queries to site(s) as applicable for potential discrepant or missing data and follow to resolution.
- Manage translation services to be provided via scope of work including submission, tracking and assurance of page equivalent upon return of translation.
- Support User Acceptance Testing (UAT) of Committee’s collaborative workspace and/or electronic adjudication platform.
- Provide operational support to the Committee Manager in the creation and maintenance of metric reporting for delivery to customer and/or internal team.
- File all project-specific trial committee documents in the Trial Master File (TMF).
Summary
Performs operational and project support activities related to Medical Committee & Adjudication Management (MCAM) contracted services to set up and support clinical trial committees.
Works with project‑assigned Committee Manager, Project Lead and functional leads, customers, service providers, investigative sites, and committee members to ensure the contracted services and expectations are carried out according to project scope, and applicable committee charter and project plan(s).
The individual in this role may support the overall implementation and ongoing oversight of one or more contracted services for assigned projects.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
Further, nothing contained herein should be construed to create an employment contract.
Occasionally, required skills/experiences for jobs are expressed in brief terms.
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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Required Skill Profession
Other General
Postúlate en Kit Empleo: kitempleo.com.ar/empleo/q2jvs
📌 Endpoint Adjudication Specialist, great opportunity for Study Coordinators in BA/Argentina (Buenos Aires)
🏢 Syneos Health
📍 Buenos Aires