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**Description****Clinical Project Specialist - Fluent English - Home Based LATAM (Argentina, Brazil, Colombia, Mexico or Peru)****Great opportunity for Clinical Trial Assistant**Come discover what our 29,000+ employees already know: work here matters everywhere.
We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world.
Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
**Why Syneos Health**- #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves.
Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.- We believe our success is a direct result of the people who are driving it - you!
We value your dedication to care for our customers and patients, so we want to focus on taking care of you.
That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.- We are continuously building the company we all want to work for and our customers want to work with.
Why?
Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
**Job responsibilities**- Set-up, maintain and/or close out project files and study information ((e.G., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.- Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings).
Follows up with team members on action items to closure.- Maintains timely and effective communication among team members and site staff.
Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status.
May contact site staff as needed for critical information.- Provide administrative support to Project Leads and functional leads.- Ensure all study documents are archived based on the appropriate guidelines and policy.- Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.
**Qualifications****What we're looking for**- Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience- Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements