Clinical Research Associate

Objective

The CRA is responsible for implementing clinical development by providing unrivaled support to the Clinical Operations team. This individual must have sufficient knowledge to work independently with confidence. Hands-on participation with the clinical team will be expected, with growing managerial/mentoring opportunities as clinical trial sites expand.

 Essential Functions                                                                                                              

• Responsible for all aspects of site management.
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to conduct the study.
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Prepare accurate and timely trip reports.
• Manage small projects under direction of a Clinical Trial Manager.
• Report, write narratives and follow-up on serious adverse experiences.
• Participate in the development of protocols and Case Report Forms as assigned.
• Manage site feasibility and start up activities.
• Negotiate study budgets with potential investigators and facilitate execution of clinical trial agreements.
• Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
• Independently perform CRF review, query generation and resolution.
• Assist with training, mentoring and development of new employees.

Qualifications                                                                                                              

• Broad knowledge of medical terminology and clinical patient management.
• Knowledge of drug therapy techniques and clinical research methodologies.
• Excellent analytical, problem solving, presentation, and office-based technology skills (including proficiency in Microsoft Suite and related software).
• Ability to travel up to 50%.

Education/Experience                                                                                                              

• Bachelor's degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• Previous experience in a site start-up role a plus, as is previous oncology experience.
• At least 5 years' experience as a CRA or equivalent experience managing clinical trials.

Knowledge/Skill/Ability                                                                                                              

• Ability to work with minimal supervision.
• Good planning and organization skills
• Good computer skills with good working knowledge of a range of computer packages
• Advanced verbal and written communication skills
• Ability to work within a project team.
• Ability to work occasional evening and weekends and travel to clinical sites as needed.

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.

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 is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.