Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Location: West Coast preferred. Accessible to (within driving distance of) major airport.
Scientific degree preferred.
Minimum – 5 years of experience as Clinical Research Associate. Experience in hematology / oncology strongly preferred.
Responsibilities include, but are not limited to:
Investigative Site Monitoring - Demonstrate a commitment to quality in all aspects of monitoring; adhere to study monitoring plans; support site identification by conducting feasibility studies as needed; conduct Pre-study Visits for Investigative Sites; effectively facilitate/negotiate contracts for assigned sites within clinical subject budget as needed; conduct Study Initiation Visits at Investigative Sites; conduct Interim Monitoring Visits at Investigative Sites; review the investigator study file and reconcile versus the Trial Master File in compliance with GCP/ICH ; perform investigational product accountability and verify storage conditions; coordinate/organize the delivery of supplies as required; validate and track payments
to assigned sites and patients travel reimbursement as needed/if applicable; and conduct Close-out Visits at Investigative Sites.
Data Integrity - Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of the subjects during their participation in a study; evaluate data query trends and interact with study team in order to improve data quality; assist investigative sites to achieve timely and accurate data entry and resolution of queries; ensure timely submission and review of CRF data and query resolution according to timelines set forth in the SMP; ensure issues of data quality are escalated and resolved/followed-up with the study team and CQA, as needed.
Subject Safety - Monitor the informed consent process; perform safety reviews/SAE reconciliations; verify correct dispensing of IP to subjects; manage Investigative Sites’ adherence to GCP, ICH guidelines and local regulations, ensure prompt reporting of unreported safety events noted during source document review.
Train and Assist Investigative Sites - Attend Investigator Meetings, contribute and present when required; train investigative site personnel in GCP/ICH and study-specific requirements, ensure new staff are promptly and adequately trained prior to performing study related activities, and monitor that sites are conducting Celgene clinical research according to the protocol, local regulatory requirements, and other appropriate regulations; serve as liaison between Celgene and assigned sites; build effective and positive relationships with site staff at assigned sites.
Communication - Identify site issues, ensure proper escalation, if necessary, and ensure resolution/follow - up; create monitoring reports, confirmation/follow-up correspondence and telephone
contacts for assigned sites; respond to audit findings if applicable; adhere to proper lines of communication within Celgene; attend and participate in study team meetings as assigned; keep information in the CTMS current; maintain calendar.
Regulatory Documentation - Compile ethics submissions dossier in consultation with the investigator; support and ensure that country specific requirements are obtained when applicable; adapt patient information and consent form to local regulatory requirements to ensure approval; review translations for ICD and study documents as needed; ensure translation and back-translation of study specific documents as required; ensure local requirements are adhered to for EC updates (annual reports, protocol amendments and study completion/termination and safety reports where applicable); maintain local document files at a country level, as needed; liaise with Regulatory Affairs department for submission and any relevant change to be reported to a Competent Authority; maintain study information in the National Trial Database where appropriate. Development – Ensure that the medical and clinical knowledge for assigned therapeutic areas is up-to date with the support of line manager; develop and maintain a good working knowledge of relevant protocols; maintain a good working knowledge of FDA, GCP/ICH requirements and relevant local regulatory requirements; mentor/coach new CRAs as needed; maintain annual qualification records. Monitoring Lead (as assigned) - serve on study team as monitoring Lead; review RFPs regarding monitoring specifications when required; develop study monitoring plan and subsequent revisions; review, track and acknowledge monitoring visit reports; manage and track monitoring site visits to ensure quality monitoring; highlight inadequate monitoring resources; track and report critical issues to study team; participate in CRF and protocol review process; conduct CRA/FM meetings. Others - Identify/evaluate potential investigators for future Celgene studies; participate and contribute to Clinical Research meetings, cross-functional activities and sharing best practices amongst the team as appropriate; contribute to adequate training of monitors in the study requirements; perform quality assessments of Celgene and CRO CRAs, as required; develop study-specific tools for Investigative Sites and CRAs/Field Monitors; CRO monitoring oversight as required; create and review WPs and SOPs if applicable; identify study process improvements.
Travel - upto 60% (mostly within US, some international (Canada))
Key (PDI) Competencies:
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.