The Senior Clinical Research Associate (Sr. CRA) position represents an opportunity to grow within an emerging medical device company. Solid knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP)/ICH, and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical. The Sr. CRA has broad exposure to clinical research tasks as a combination of in-house and field work. The Sr. CRA works closely with the CRA Manager, Project Manager(s) and Clinical Project Team to support various aspects of a Clinical Trial and related regulatory activities.

What you will be doing:

• 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 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.
• Ensure compliance with protocol and overall clinical objectives.
• 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.
• Ensure investigator involvement in the study and IRB/EC oversight.
• Follow-through after visits to see that all outstanding requests/needs are fulfilled.
• Raise issues of significance to the appropriate level for resolution.
• Able to help site navigate informed consent issues and support IRB submission process, as needed.

Site Management Responsibilities

• During study start-up and throughout study conduct, work closely with the Project Manager to review and/or draft study documents, such as Clinical Monitoring Plan, and Informed Consent Template. Lead review of site-level informed consents before and after IRB submission.
• Work with sites between monitoring visits on recruitment and enrollment challenges, ensure timely data entry and query resolution, and follow-up challenges.
• Ensure sites have submitted relevant source documents related to safety events. Work with coordinators to ensure that safety events are reported in a timely manner, and work with CPM to ensure that all information is available for DSMB reporting.
• Ensure sites are continuing follow-up of subjects in accordance with protocol requirements.
• Active participation in site calls between monitoring visits.
• Support CAPA identification and resolution at research sites.
• Proactively identify and support process improvement at study or site level. Work with key stakeholders within the organization and externally to resolve.
• Participate in other activities as needed.

Set up and maintenance of Regulatory Master File

• Organize site study files
• Work closely with other CRAs for coverage in collecting and reviewing regulatory documentation and assuring consistency between RMF and site files.
• Generate and maintain study checklists as necessary and keep accurate records of all essential study material(s).
• Responsible for accurate and timely oversight and maintenance of RMF.
• Demonstrated expertise in understanding and managing clinical study documentation.
• Proper and timely filing of all relevant study documents and standardized filing across all studies, per applicable SOPs and regulatory standards.

Qualifications:

• Minimum of a 4-year Bachelor’s degree, preferably in life sciences field and good familiarity with medical terminology; experience in Neuroscience or device studies preferred
• Basic computer skills with proficiency in Microsoft suite of products, including Word, Excel, and PowerPoint, is required; Familiarity with EDC is also required.
• Ability to foster relationships with clinical sites and colleagues. Experience mentoring and co-monitoring junior CRAs is preferred. Audit experience also preferred.
• 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
• Excellent work ethic with desire to be a valuable contributing team member
• 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;