Senior Clinical Research Associate

Dallas        ·         Full time

What you will be doing:

The job holder’s duties and responsibilities will support clinical trial activities within the USA and Canada and may include any of the following:

• 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.
• The job holder’s duties or responsibilities are not limited to those listed above and job holder is expected to perform additional duties and responsibilities as assigned by his/her managers

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 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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender/gender identity, age, disability, marital status, sexual orientation, national origin, veteran status, and any other legally protected status entitled to protection under federal, state, or local anti-discrimination laws.

Please click here to apply.