Job Description
Immediate and Urgent opening for Senior CRA with growing bio tech company! Client focused on the discovery and the development of novel treatment options for retinal diseases with significant unmet medical needs.
- Sr. CRA will be responsible will be responsible for working with the study manager to develop study processes and procedures.
- They will act as a key contact for CROs and vendors to address study issues and support the successful execution of clinical trials.
Qualifications:
- 4+ years of in-house CRA experience - start up through conduct and closure
- Tracking regulatory documents/excel/IRB submissions
- Previous Biotech/CRO/Sponsor experience
- 4 year degree (scientific discipline preferred, not required)
- Vendor management experience (supporting study managers on vendor/CRO oversight)
- Experience reviewing monitoring reports
- Ability to work in a fast paced environment
- Thorough understanding of ICH-GCP guidelines and their implementation in clinical trials
- On-site clinical trial monitoring experience is preferred
- The ability to handle multiple priorities within matrix environment is required
Job Description:
- Track and monitor day to day study related activities such as patient enrollment, data entry, protocol deviations, and other study matrixes. Flag potential issues for the clinical study manager and work with clinical team to resolve issues.
- Work with clinical study manager to develop study processes and procedures and then implement those process and procedures.
- Act as key contact for global clinical research organizations (CROs) and vendors to answer questions regarding study processes and procedures, as well as to monitor CRO activities.
- Participate in clinical data review as part of the database cleaning process, issue data queries, and confirm responses, as well as coordinate activities with other departments.
- Develop study documents such as informed consents, source documents, and meeting materials.
- Review of monitoring reports and work with the monitor to resolve any issues.
- Review of study required regulatory documents and confirm sites meet all qualifications to enroll patients.
- Conduct CRO and site staff trainings. Present information at investigator meetings.
- May require occasional travel.
Work Environment
- This role is REMOTE - Looking for candidate in NJ/NY/PA/CT/MA/DE
- Currently working virtually, however after the pandemic lifts manager want this person to have the ability to come in the NYC office for major meetings (very rare)
- Working hours 9:00 - 5:00pm (can be flexible with this as needed).
- Travel: 10% (minimal travel) site visits
- Access to Benefits. Medical, Vision, Dental, 401(k).
About Aerotek:
Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.
