What are the responsibilities and job description for the Senior Clinical Research Associate position at Actalent?
Description:
- Conduct site qualification, initiation, monitoring and closeout visits and create documentation of such through accurate and detailed visit reports
- Monitor source documents to EDC for completeness and accuracy through verification of subject records and source documentation
- Verify that all subjects meet inclusion/exclusion criteria
- Review of all source records for patient safety and ensure complete documentation of all subject safety events
- Review regulatory binder to ensure complete, accurate, and up-to-date regulatory compliance at the site
- Train site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasks
- Follow through after visit to outstanding requests/needs are fulfilled
- Ensure compliance with protocol and overall clinical objectives
- Raise issues of significance to the appropriate level for resolution
- Ensure investigator involvement in the study and IRB/EC oversight
- Responsible for accurate and timely oversight and maintenance of RMF
- Ability to support activities in other geographies as needed
- Ability to assist as project manager where needed including but not limited to Site onboarding to include site qualification, contract negotiation/budgeting and IRB/EC approval for the study; ensure all regulatory documentation is collected and current during the study
Compilation of Regulatory Submissions:
- Assist in organizing documentation for regulatory submissions
- Create electronic copies of submitted documents
- File all regulatory correspondence in the TMF
- Responsible for accurate and timely maintenance of both electronic and paper files
Set up and maintenance of Trial Master File:
- Organize site study files
- Work closely with other CRAs for coverage in collecting and reviewing regulatory documentation and assuring consistency between TMF and site files
- Generate and maintain study checklists as necessary and keeps accurate records of all essential study material(s)
- Responsible for accurate and timely oversight and maintenance of RMF
Additional Skills & Qualifications:
- Bachelor’s degree in a life science field
- At least 5 years relevant industry experience in clinical research environment; preferably as a monitor
- Professional English is a MUST, additional languages are preferred
- Working knowledge of Good Clinical Practices (ICH GCP) and ISO14155
- Current working knowledge of clinical trial practices within US and clinical trial regulations; familiarity with EU MDR is a plus
- Familiarity with medical terminology
- Formal GCP Certification required, CRA Certification preferred
- Basic computer skills with proficiency in Microsoft Word and Excel required, PowerPoint and Database experience desirable
- Ability to foster relationships with clinical sites and colleagues
- Ability to support several projects simultaneously, a flexible working style and attention to detail are essential
- Able to work independently with excellent time management skills
- Approximately 50% travel that will vary over time, including international travel (able to travel abroad and obtain relevant visas) within US and Canada and as needed to the Europe, Israel and Asia; Ideal candidate will reside within USA with easy access to travel options
- Ability to accommodate US, Europe, Israel and Asia working hours, as appropriate
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 : $100,000 - $140,000
