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Intern (4-6 Months)
3 weeks ago
**Description**
**Intern**
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.
Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**
**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- 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.
**Qualifications**
**INTERNSHIP**:
**CLINICAL OPERATIONS**
**Summary**
Performs all administrative activities associated with the management of a clinical trial and initiatives led by the Clinical Development Leaders. Actively participates in delivering results that meet internal and external customer expectations, project goals, timelines, and assigned budget. Provides overall support to program/initiative/process leads to ensure the successful completion of deliverables.
Including but not limited to:
- Project Administration - Attends Quick Start camp, Quality Finish Camp, and may attend process review and Kick-Off Meetings and other project meetings as required. Participates in Trial Master File audits. Assists in preparation for and attends investigator meetings. Prepares and maintains Study Reference Manual and site reference tools. Drafts and prepares documents for mass dissemination. Arranges for receipt of administrative and regulatory documents. Coordinates the packaging, shipping, and tracking of study supplies and materials. Transcribes accurate meeting minutes and action items to meet the specifications of the project team and Sponsor.
- Reporting - Assists project team with compliance or maintenance of regulatory standards, Standard Operating Procedures (SOPs), and Work Instructions (WI). Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and TMF Plan. Reviews and submits Essential Regulatory Documents for second review. May conduct second review of Essential Regulatory Documents. Prepares and disseminates Investigator regulatory binder.
- Communication - 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.