Clinical Study Associate II
Posting ID: JP-002027291
This Opportunity is with a company whose research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.
- Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.
- Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Clinical Study Oversight Plan (CSOP).
- Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.
- Distribute key study documents to the CRO and vendors as appropriate.
- Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.
- Collect information and coordinate with Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov).
- Support Fair Market Value process in evaluating study budgets
- Under supervision, review and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor.
- Compile and maintain a monitoring review spreadsheet.
- Compile and maintain CRO Oversight Monitoring (CROOM) visit output Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to your supervisor.
- Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices).
- Analyze study site metrics reports to identify potential areas of concern and bring to supervisor's attention.
Additional Skills & Qualifications:
- Experience considered relevant includes 2-3 years of clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred.
- A Bachelor's degree (preferred in Life Sciences) with relevant clinical development experience is acceptable.
- Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
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.
Recruiter: Alfredo Ardila
Phone: (973) 829-4461