Responsibilities
The Site Activation Specialist is responsible for supporting operational activities related to site evaluation, activation , initiation, monitoring and close out to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and standards providing technical and logistical support to deliver Investigator Initiation and Study Start Up

* Clinical Trial Site Activation & Conduct
• Assist with study site activation activities and support and/or coordinate EC submissions when needed.
• Work with investigator site s for Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, EC submission and status.
• In charge of regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions
• Assist with preparation, handling and distribution of Clinical Trial Supplies and management of CRFs queries.
• Problem solve identified issues with appropriate timely.
• Support investigator site s and study teams in preparation and providing responses to site audits/inspections.

* Communication
• Act as point of contact with the team members and investigator site as needed.
• Establish tools for efficient updates regarding site status, issues, delays, and approvals.

* Clinical Trial Monitoring Support
• Support with coaching and training of site personnel to ensure ongoing compliance in accordance with prevailing laws, GCP, and the client standards.
• Conduct or oversee site activation activities, IIP completion, and site budget ensuring timely management of emerging issues.
• Support conducting remote monitoring activities, data queries with a focus on technical/logistical activities that facilitate inspection readiness.
• Identify and resolve site i ssues; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues

Equal Opportunities Plan . Its objective is to achieve the principle of equality of opportunity in Syneos Health's employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions.

#LI-IP1• School diploma/certificate or equivalent combination of education, training and experience; BS/BA of Bachelor's degree in life sciences preferred.

• 2 years relevant experience in clinical site management

• Experience in study activation and site management is an asset

• Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations

• Must be fluent in English, and the regulatory language of the appointed location.

• Demonstrated knowledge of clinical research and development processes and ability to gain command of process details

• Demonstrated knowledge of global and local regulatory requirements

• Demonstrated understanding of key operational elements of a clinical trial (e.g. study start-up, conduct, close-out activities, reporting, etc.)

• Proven ability to work independently and as a team member

• Ability to organize tasks, time and priorities, ability to multi-task

• Understand basic medical terminology, GCP requirements and proficient in computer operations.