Objective

The Clinical Trial Associate (CTA) provides comprehensive administrative and operational support to the Clinical Operations Team, ensuring the efficient conduct of clinical studies and the achievement of project and corporate goals.  This includes managing study documentation, facilitating potential site outreach, coordinating meetings, and overseeing the electronic Trial Master File (eTMF) system.  The role also involves supporting trial progress tracking, assisting with the production of slide presentations, and coordinating the procurement and distribution of study materials.  By maintaining meticulous records and ensuring compliance with Good Clinical Practice (GCP) guidelines, this position plays a critical role in the successful execution and documentation of clinical trials.
 

Essential Functions

 

• Provide general administrative support to the Clinical Operations and Project Management Departments.

• Assist the Clinical Operations teams with ongoing conduct of studies and completion of all required tasks to meet project and corporate goals.

• Attend meetings to assist the Clinical Trial Managers  with e.g., internal and/or external meeting coordination, activity preparation and meeting minutes generation.
• Facilitate outreach to potential clinical trial sites and initial site feasibility procedures.
• Lead quarterly documentation and compliance checks utilizing internal trackers and eQMS system.

• Act as super user for the electronic Trial Master File (eTMF) system and be responsible for tracking eTMF progress for Perspective Therapeutics projects.

• Support the creation of professional and visually appealing slide presentations for internal and external stakeholders. Collaborate with team members to gather content, design slides, and ensure presentations effectively communicate key messages and project updates.

• Set up, collect, register, organize, and maintain clinical study documentation, including preparation for internal/external audits, final reconciliation, and archival according to GCP guidelines.

• Coordinate ordering/dispatch and tracking of study materials (e.g. lab supplies, equipment supplies, forms) as appropriate.

• Organize data collection forms and other study materials i.e., log in, tracking, quality control, as appropriate for the study.

• Assist in the tracking and distribution of correspondence and reports.

• Coordinate document translation.

 

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.).
• Research or health care-related academic or work experience preferred.

 

Knowledge / Skill / Ability

 

• Excellent computer literacy and application skills e.g., Microsoft Word, Excel, PowerPoint, Outlook.
• Ability to become familiar with ICH-GCP, FDA, and other appropriate regulations, and relevant SOPs.
• Possess strong organizational skills and the ability to manage multiple tasks with meticulous attention to detail.
• Ability to work collaboratively in a team-oriented environment.
• Clear written and verbal communication skills, in English

Work Environment

The work environment characteristics described here are representative of those an employee encounters  while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 

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

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.

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.