Project Specialist (Sponsor Dedicated)

Syneos HealthClinical research

Mexico, RemoteFull-Time

Salary not disclosed

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Job Details

Have an associate degree or equivalent qualification in life sciences, medicine, pharmacy, nursing, or a related field, or an equivalent combination of education and experience.
Know Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
Have strong organizational skills.
Be able to manage time and work independently.
Have high proficiency with full MS Office applications.
Have strong written and spoken communication, presentation, and interpersonal skills.
Have high-level competence in English.
Be able to travel approximately 5% to Syneos and/or client offices if necessary; this is preferred.
Portuguese or French knowledge is valued.

Set up, maintain, and close out project files and study information in databases and systems.
Maintain regulatory documents, Trial Master File records, enrollment information, adverse event records, site supplies, IRB re-approvals, and data queries.
Prepare and distribute meeting minutes and action items for internal and external meetings.
Follow up with team members to bring action items to closure.
Maintain timely communication among team members and site staff.
Keep Project Leadership and CRAs informed of site and study status, and contact site staff for critical information as needed.
Provide administrative support to Project Leads and functional leads.
Archive study documents according to applicable guidelines and policies.
Support quality assurance activities, including audit and internal review preparation, documentation, and resolution of actionable issues.

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