Global Study Associate – FSP

This is a fully remote position, open to applicants in Spain, +4 more countries.

📋 Description

• Provide support for Phase 1, 2, 3, and 4 clinical studies with appropriate guidance.

• Assist in the feasibility, start-up, maintenance, and close-out activities of studies and sites.

• Oversee the review, collection, and tracking of essential documents for studies and sites.

• Aid in the preparation and upkeep of study documents and manuals.

• Supervise the Trial Master File.

• Ensure that study documents are received, reviewed, and filed in accordance with SOPs, GCP, and relevant regulations.

• Organize meetings related to the study, prepare agendas, take minutes, and maintain logs for risks, issues, and decisions.

• Lead and present in study-related meetings as necessary.

• Conduct site monitoring and co-monitoring visits.

• Address findings from internal and site audits regarding quality assurance.

• Coordinate and manage activities of third-party vendors.

• Track and maintain study status, enrollment, site queries, deviations, and study-level documents and plans.

• Engage in clinical trial team meetings and collaborative efforts.

• Support oversight of study sites and review performance metrics and monitoring reports.

• Assist with study data activities, such as data review, creation and resolution of queries, deviation reviews, and safety assessments.

• Provide cross-functional oversight of CRO and vendor activities.

• Review and validate contracted vendor activities and invoices.

• Facilitate study reporting and tracking through relevant systems and technology.

• Support study leads in achieving cross-functional alignment on study timelines.

• Complete necessary training, timesheets, expense reports, and updates to your CV.

• Adhere to Parexel processes, ICH-GCPs, and relevant requirements.

⛳️ Requirements

• Excellent verbal and written communication skills.

• Capable of working independently as well as collaboratively within a team.

• Proficiency in Microsoft Word, Excel, and PowerPoint.

• Ability to prioritize and manage multiple tasks effectively.

• A BA or BS degree, a nursing degree, or an equivalent qualification is required.

• Minimum of 3 years of experience in clinical studies as a SCRA or Lead CRA.

• Familiarity with Good Clinical Practice (GCP) regulations and Standard Operating Procedures.

• Understanding of study phases and their relevance in clinical development.

• Proficient in electronic systems, including the Trial Master File and CTMS (e.g., Veeva Vault, Smartsheet, SharePoint).

• Knowledgeable in computer applications for database management.

• Willingness to travel 10% to 20% of the time may be necessary.

🏝️ Benefits

• Competitive salary.

• Comprehensive benefits package.

• Medical care plan covering Health, Dental, and Vision.

• Life Assurance.

• Positive work environment.

• Culture focused on teamwork and collaboration.

• Access to innovative technology.

• Exceptional training opportunities.

• Paid time off.

• Life insurance.

• Health insurance.

• Additional benefits aligned with applicable plans.

• Potential eligibility for extra incentives, bonuses, or other compensation programs.