What are the responsibilities and job description for the Clinical Trial Associate position at Actalent?
Opportunity to join a multinational specialty pharmaceutical company! This company has over 800 products including branded pharmaceuticals, branded generics, and over-the-counter products across the globe.
TOP 3 MUST HAVES:
- 1-4 years CTA experience
- TMF maintenance
- Excellent verbal and written skills as they will be interacting with the internal study teams. sites, vendors, and CROs
Responsibilities
- Collaborates on and supports CTM on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection, Trial Master File structure and preparation, and communication with clinical trial sites regarding administrative documentation, support materials and training
- Supports CTM and clinical operations team to ensure compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all clinical investigations and post-market studies
- Supports CTM and clinical operations in communication with clinical trial sites regarding study conduct, monitoring, logistical management of follow-up and close out study visits to ensure compliance with protocols and GCP requirements
Additional Skills & Qualifications:
- Bachelor’s degree in a health profession or science
- At least 2 years of on-going clinical trials experience
- Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements
- Knowledge of medical terminology
- Ability to effectively work independently
- Excellent verbal and written communication skills plus computer proficiency (Word, Excel, Outlook)
- Travel may be required (minimal)
- Individual must have good verbal skills and written skills plus a demonstrated ability to communicate clearly and professionally
- Analytical and Reading Skills
- Ability to read, analyze, interpret and assist in the creation and refinement of company procedures
- While performing the duties of this job the employee may be required to perform tasks involving lifting weights of up to 30 pounds for short durations
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $40 - $50