Essential Functions

• Regulatory Document Management:
  • Collect, review, and track all required regulatory documents from selected trial sites.
  • Ensure compliance with regulatory standards and guidelines.
• Site Contract and Budget Negotiations:
  • Engage in negotiations with clinical trial sites for contracts and budgets.
  • Collaborate with the clinical trial manager and legal and finance teams to finalize agreements.
  • Execute amendments to contracts/budgets as needed.
• IRB Submissions and Approvals:
  • Prepare and submit central Institutional Review Board (IRB) application in collaboration with the site and study team.
  • Tracks local IRB submissions and approvals.
  • Facilitate communication between Perspective, sites and IRBs to obtain timely approvals.
• Equipment Provisioning:
  • Coordinate the provisioning of necessary equipment at trial sites.
  • Ensure that all equipment is compliant with trial protocols and regulations.
• Greenlight Checklist for Drug Release:
  • Execute a comprehensive checklist for drug release in collaboration with relevant stakeholders.
  • Confirm that all site startup activities are completed and meet the required standards before drug release.
• Communication and Collaboration:
  • Maintain open communication with internal and external stakeholders.
  • Collaborate with cross-functional teams to address challenges and ensure a smooth startup process.
• Documentation and Reporting:
  • Maintain accurate and up-to-date records of all site startup activities.
  • Generate reports for management and project teams as needed.
  • File all essential documents in the study eTMF

Qualifications

Education/Experience

• Bachelor's degree in a relevant field (life sciences, healthcare, etc.).
• Previous experience in clinical trial site startup or a related field. (2 years preferred)

Knowledge / Skill / Ability

• Strong negotiation and communication skills.
• Experience managing clinical trial site contracts and budgets
• Detail-oriented with excellent organizational and time-management abilities.
• Ability to work collaboratively in a team-oriented environment.
• Knowledge of regulatory requirements and guidelines governing clinical trials.
• Excellent written, verbal and interpersonal communication skills, with proven ability to collaborate, communicate and manage well at all levels of the organization.
• Must be willing to travel up to 10% of the time.

Work Environment

• May be required to sit or stand for long periods of 8+ hours a day while performing duties. 

Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.