Junior Study Start Up Specialist

This is a fully remote position, open to applicants in Spain, +1 more country.

📋 Description

• Oversee and monitor site feasibility operations

• Ensure that confidentiality agreements are established

• Gather and manage regulatory, Competent Authority, and Ethics Committee submission details in JVRIM, CTIS, and similar platforms

• Confirm that clinical trial insurance is arranged for submission

• Organize translations of submission materials

• Develop, review, and tailor country- and site-specific Informed Consent Forms

• Obtain approval for regulatory documents and contracts with relevant teams and vendors

• Collect and evaluate initial regulatory packets and site contracts

• Facilitate site activation processes, regulatory and ethics approvals, and essential-document evaluation for Investigational Product release

• Prepare ongoing submissions, amendments, periodic notifications, and safety alerts

• Ensure that pertinent documents are filed in the Trial Master File

• Collaborate with CRAs, CTMs, contract vendors, and Regulatory Leads to expedite trial initiation

• Notify team members when regulatory and contractual documents are finalized

• Participate in cross-functional project meetings and provide status updates

• Identify, address, and escalate site-related issues and risks

• Review and give feedback on site performance metrics

• Maintain precise SSU data tracking entries

• Promote process improvement initiatives

• Assist in the formulation of start-up plans and essential document checklists

• Work in conjunction with regulatory, legal, and clinical operations teams to ensure compliant and efficient trial initiation

• Accurately complete required training, timesheets, and expense reports in a timely manner

• Stay informed of and adhere to Parexel processes, ICH-GCPs, and relevant regulations

• Support investigator sites in preparing for clinical trials and reducing site activation timelines

⛳️ Requirements

• Bachelor’s degree or 3 years of clinical research or related experience, or a suitable combination of education, training, and experience

• Experience in the pharmaceutical or related industry

• Prior experience in a start-up team, as a Clinical Trial Specialist, or in a similar position, having contributed to global clinical trials

• Strong understanding of GCP and regulatory requirements

• Capability to work autonomously in a dynamic environment

• Proficiency in identifying and resolving site issues independently while effectively escalating complex challenges

• Adaptability and eagerness to engage in process improvement initiatives

• Exceptional verbal and written communication skills

• Ability to collaborate efficiently with regulatory, legal, and clinical operations teams

• Experience with in-house trials or process design is preferred

🏝️ Benefits

• Competitive salary

• Comprehensive benefits package

• Medical care plan: Health, Dental & Vision

• Life Assurance

• Supportive work environment

• Culture of teamwork and collaboration

• Colleagues who inspire and tackle challenges together

• Cutting-edge technology

• Outstanding training opportunities

• Paid time off

• Health insurance

• Additional benefits in accordance with applicable plans

• Potential eligibility for extra incentives, bonuses, or alternative compensation programs