Clinical Site Start Up Specialist

Objective The Clinical Site Startup Specialist plays a pivotal role in the successful initiation of clinical trials by overseeing and coordinating all activities related to site startup.

This position involves meticulous management, tracking, and facilitation of processes, from site selection through the Site Initiation Visit (SIV) phase.

The specialist will be responsible for ensuring seamless execution of various tasks, including regulatory document collection, site contract and budget negotiations, IRB submissions and approvals, equipment provisioning, and the completion of a comprehensive greenlight checklist for drug release.

As the owner of the site’s contract and budget the clinical site startup specialist will also be responsible for processing any amendments that are needed to site budget or contract and reviewing site payment invoices to ensure compliance the executed budget.

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.

Review all invoices to ensure compliance with executed budgets prior to payment. 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 To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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. 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. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

Duties, responsibilities, and activities may change at any time with or without notice. For information on Perspective Therapeutics, visit our website at : www.

perspectivetherapeutics.com . 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.

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