This is a pharmaceutical company that focuses on targeted cancer therapies.
Clinical Research Associate — JO-2010-5496
Therapeutic Area: Cancer
The Clinical Research Associate supports the Clinical Trial Managers and the Director of Clinical Operations in the conduct of one or more clinical studies. S/he interacts with the Clinical Operations team and collaborates effectively with CROs, vendors, and clinical trial sites. S/he 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.
Essential Duties and Responsibilities
- Assist in overseeing clinical trials from initiation, planning, execution, maintenance, and close-out.
- Coordinate investigational site startup activities, including the creation, preparation, and shipment of documentation, Ethics Committee submissions and approvals, reviewing/approving essential document packages, reviewing site changes to ICFs, facilitating the completion of clinical study agreements and budgets, and shipment of clinical supplies.
- Coordinate contract vendors and CRO activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs. Review invoices from vendors/consultants as per contract.
- 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. Assist in the planning of investigator meetings and/or site and CRA training.
- Assist with protocol, case report form, source document template development, internal SOP/guideline development, final report preparation. 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 oversight of sample collection.
- 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.
- Participate in the development, review, and implementation of departmental SOPs and processes.
Qualifications (Education & Experience)
- Bachelor’s or equivalent in a scientific or healthcare 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%.
Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs and Clinical Operations professionals in life sciences companies in the United States and around the world.
TriNet Pharma has identified and placed Medical Science Liaisons, Clinical Trial Liaisons, and director-level and executive-level professionals across multiple therapeutic areas. The company has a performance-based culture built upon trust, leadership, expertise, and accountability, which have allowed it to enjoy year-over-year growth.
Learn more at www.trinetpharma.com.