Clinical Trial Support Spec. I

As a Clinical Trial Support Specialist I you will assist the Clinical Trial Manager (CTM) with site prescreening activities, site selection and qualification visits, collaborate with other centralized functions (e.g., Study File Management, Payment Services) to ensure study documents are collected prior to site initiation (e.g., FDA 1572, CV's, ICF, financial disclosure forms, lab normal ranges and certification, IRB approvals), assist with ordering test article, central lab supplies and other study supplies, assist with site initiation visits, enter information into IMPACT and check study documents are correctly filed in EDMS. You will support the CTM with in-coming and out-going site communications, support the CTM with communications among team members and Field Operations, assist the CTM in documenting study team meetings, instructions, decision, etc., assist the CTM in managing global communications, coordinate and send study documentation to sites (e.g. letters, faxes, emails), assist with re-ordering test article, central lab supplies, and other study supplies, assist the CTM in tracking and analyzing patient enrollment, assist the CTM in researching and analyzing issues with labs or CRO, support the CTM in resolution of DCF inquiries as appropriate, assist the CTM in tracking annual study documents, collaborate closely with Study File Management to relay study specific information (e.g. study documents, files and others), update IMPACT as needed, ensure study documents are correctly filed in EDMS and collaborate closely with Clinical Pharmacy and Field Operations to track and manage drug accountability. You will also collaborate closely with a CRO (if applicable) to reconcile test article, update IMPACT as needed and reconcile and ensure all final study documents are corrected filed in EDMS.This position requires a BS/BA and 2 years clinical research or relevant experience, knowledge of FDA regulations regarding Clinical Research and Good Clinical Practice (GCP) and 2 years experience participating on Clinical Study Teams. Good skills in written and oral communication of scientific data are also required.Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.For more information, visit our website at