Clinical Project Associate - Wfh
By Sarah Cannon At Tennessee, United States
Assist with confirming the qualifications of investigators and investigative sites throughout the conduct of the clinical trial
Set-up, document collection/upload of files to the TMF/eTMF
Perform initial quality review of documents prior to upload/filing in the TMF/eTMF
Partner with document specialist to maintain the Trial Master File (TMF) in “audit ready” condition from study start to completion
Review study documents to ensure they are current, complete and accurate
It’s More Than a Career, It’s a Mission.

Are you looking for an exciting opportunity to join a dynamic team in a fast-paced environment? We are seeking a Clinical Project Specialist to join our team and help us develop and execute clinical trials. You will be responsible for managing the day-to-day operations of clinical trials, including protocol development, data management, and regulatory compliance. If you have a passion for clinical research and are looking for a challenging and rewarding career, this could be the perfect job for you!

Overview A Clinical Project Specialist is a professional who works in the field of clinical research and is responsible for managing clinical projects. They are responsible for the planning, coordination, and execution of clinical trials and studies. They ensure that the clinical trial is conducted in accordance with the protocol, applicable regulations, and good clinical practice (GCP). Detailed Job Description A Clinical Project Specialist is responsible for the planning, coordination, and execution of clinical trials and studies. They are responsible for developing and managing project timelines, budgets, and resources. They are also responsible for ensuring that the clinical trial is conducted in accordance with the protocol, applicable regulations, and good clinical practice (GCP). They are responsible for the coordination of all activities related to the clinical trial, including the recruitment of study participants, data collection, and data analysis. They are also responsible for the preparation of regulatory documents, such as informed consent forms and study protocols. Job Skills Required
• Knowledge of clinical research and clinical trial processes
• Knowledge of applicable regulations and good clinical practice (GCP)
• Excellent organizational and project management skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to work under pressure and meet deadlines
• Proficiency in Microsoft Office applications
Job Qualifications
• Bachelor’s degree in a related field
• At least two years of experience in clinical research or clinical trials
• Certification in clinical research or clinical trials (preferred)
Job Knowledge
• Knowledge of clinical research and clinical trial processes
• Knowledge of applicable regulations and good clinical practice (GCP)
• Knowledge of data collection and analysis methods
• Knowledge of medical terminology
Job Experience
• At least two years of experience in clinical research or clinical trials
• Experience in project management
• Experience in data collection and analysis
Job Responsibilities
• Develop and manage project timelines, budgets, and resources
• Coordinate all activities related to the clinical trial, including the recruitment of study participants, data collection, and data analysis
• Prepare regulatory documents, such as informed consent forms and study protocols
• Monitor the progress of the clinical trial and ensure that it is conducted in accordance with the protocol, applicable regulations, and good clinical practice (GCP)
• Analyze and interpret data from the clinical trial
• Prepare reports and presentations on the results of the clinical trial