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CLINICAL DEVELOPMENT COORDINATOR
Maintains contact with investigative sites on patient issues; keeps abreast of patient accrual through the CRO; first point of contact for CRO on study matters; generates and updates study reports for internal circulation; supports all operational aspects of planning, conduct, and reporting of clinical trials.
• Interact closely with various internal departments at Argos: Production (Scheduler), QC, QA, Shipping/Receiving, Molecular Biology and Immunology Groups relative to optimization of production timing of RNA, leukapheresis, vaccine production, vaccine release and Immunological Monitoring.
• Communicate with CRO on all clinical matters related to the screening and accrual of patients. Keep the organization informed of the status of new patients.
• Insure that first apheresis and vaccination events at the clinical sites are monitored by the CRO, and if necessary accompany the monitor. Make recommendations on correcting site deficiencies and assist the study coordinators on any logistic or clinical issue. Assist with re-initiation of sites as needed.
• Manage the CRO, Clinical Trial Operations Team, to oversee the creation and execution of the clinical trial activities in accordance with Good Clinical Practices (GCP).
• Assist in the preparation of protocols, protocol amendments, CRFs, Clinical Procedures Manuals, Study Specific Forms.
• Through the CRO, manage activities with the clinical sites related to patient accrual and procedures required for the administration of vaccine. This includes monitoring, documentation (CRF flow), and reporting of adverse events/serious adverse events.
• Collaborate with CRO to ensure the smooth operation of the project, identify improvements and develop contingency plans and alternate strategies.
• Assist in the selection of investigators and study sites, assist in the planning of investigator meetings. Participation in team meetings, pre-study visits and site initiation visits.
• Insure that regulatory documents are received in a timely manner from the CRO and that monitoring reports are received in a timely manner and meet the sponsorís requirements.
• Maintain study status report needed by the VP of Clinical Development; work closely with the VP of Clinical Development on any issue requiring action with the sites and/or CRO. This would include collecting all information necessary for annual reports and amendments to the protocol.
• 25 % domestic travel may be required during the initiation phase of studies. Occasional co-monitoring trips will be needed during the course of the study.
• Medical Technologist with 5 years experience in a clinical research setting, or a BS degree in related scientific discipline and 5 years experience in a clinical research setting.
• The successful candidate must be knowledgeable in the clinical development process and in cGCPs.
• Previous industry experience, preferably in cell-therapy.
• Experience with cell culture and/or blood bank is preferred.
• Familiarity with standard oncology terms as well as staging and grading systems.
• Very good interpersonal and communication skills as well as very good written communication.
• Ability to operate a recent version of MS Office software, including Word, Excel and Outlook.
• Ability to travel during study initiation and to co-monitor as needed, approximately 25%.
We offer a competitive compensation package along with outstanding benefits.
For confidential consideration, please
a resume with a cover letter and salary
Argos Therapeutics is an Equal Opportunity Employer.