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Clinical Trial Specialist

Company: DOCS
Location: Philadelphia
Posted on: March 28, 2020

Job Description:

Clinical Trial SpecialistKey Responsibilities include:--- -- -- -- -- -- -- -- -- -- Contributing to the preparation of Training Materials (Investigator Meetings, Site Evaluation and Initiation Training)--- -- -- -- -- -- -- -- -- -- Managing process for planning and procuring ancillary clinical supplies --- -- -- -- -- -- -- -- -- -- Facilitating and collating country recruitment plans --- -- -- -- -- -- -- -- -- -- Creating and managing study specific tools such as recruitment and retention materials and study newsletters --- -- -- -- -- -- -- -- -- -- Maintaining study level storyboard --- -- -- -- -- -- -- -- -- -- Facilitating authoring of Investigational Product Information Manual (IPIM) and study specific Important Protocol Deviation (IPD) list --- -- -- -- -- -- -- -- -- -- Compiling IRB/EC submission documentation --- -- -- -- -- -- -- -- -- -- Assisting with GDO Operational Review preparation --- -- -- -- -- -- -- -- -- -- Preparing Clinical Study Team (CST) meeting agendas and minutes --- -- -- -- -- -- -- -- -- -- Managing global versioning and distribution of informed consent forms (ICFs) --- -- -- -- -- -- -- -- -- -- Facilitating cross functional meetings --- -- -- -- -- -- -- -- -- -- Submitting documents to trial master file (TMF) in EPICCritical Success Factors for the Role include:--- -- -- -- -- -- -- -- -- -- Ability to understand technical, scientific and medical information--- -- -- -- -- -- -- -- -- -- Understanding of drug development process--- -- -- -- -- -- -- -- -- -- Familiar with advanced concepts of clinical research--- -- -- -- -- -- -- -- -- -- Advanced computer skills--- -- -- -- -- -- -- -- -- -- Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements--- -- -- -- -- -- -- -- -- -- Ability to write and present clearly using scientific and clinical issues terminology--- -- -- -- -- -- -- -- -- -- Experience dealing with time demands, incomplete information or unexpected events--- -- -- -- -- -- -- -- -- -- Good organizational and planning skills--- -- -- -- -- -- -- -- -- -- Experience working effectively in a team/matrix environment DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

Keywords: DOCS, Philadelphia , Clinical Trial Specialist, Healthcare , Philadelphia, Pennsylvania

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