Oncology CRA - NorthEast Region
We are seeking a highly motivated individual to join SRG as a Clinical Research Associate (CRA) to support one of our innovative pharmaceutical clients. The Clinical Research Associate supports the Clinical Trial Managers and Director of Clinical Operations in the conduct of one or more clinical studies. The CRA will interact with the Clinical Operations team and collaborate effectively with CROs, vendors and clinical trial sites. The CRA supports the timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. This position is REMOTE based in the NorthEast region (MA, PA, NY, NJ, CT, NH, ME).
- Assist in overseeing clinical trials from initiation, planning, execution, maintenance and close-out.
- Coordinate and maintain relevant tracking systems for subject screening, enrollment, study visits, data entry, query resolution.
- Review and approve Site selection/Visit reports: Qualification Visits, Initiation Visit Reports and Interim Monitoring Visit Reports on an ongoing basis.
- Participate in Site Initiation Visits.
- Conduct co-monitoring visits to oversee CRO personnel and study conduct at the site.
- Support in the review of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT.
- Review clinical databases on a real time basis to identify/resolve data entry issues, tracks the query process to identify/report evolving trends in the data.
- Coordinate the exchange of TMF documents with external service providers as applicable and periodic reviews and QC of the Trial Master File to ensure audit and inspection readiness.
- Serve as a liaison and resource for investigational sites.
- Travel as required to carry out responsibilities.
- Bachelors or equivalent in a scientific or health care field required.
- Minimum of 2-3 years of CRA experience in the biotechnology or pharmaceutical industry required.
- Experience in oncology clinical trials preferred.
- Clinical operations experience at a small or mid-size company preferred.
- Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities.
- Strong Knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations.
- Excellent verbal and written communication skills.
- Ability to collaborate and respond to changing circumstances and needs.
- Ability to travel up to approximately 25-40%.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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