-Set-up, populate and accurately maintain information in tracking and communication tools (e.g. IMPACT, ISSIS, Clinical Partners Portal and eRoom*) and support others in the usage of these systems.
-Initiate and maintain production of study documents, ensuring template and version compliance.
- Provide input into non-drug project work including training activities and development of procedures as needed.
- Liaise with internal and external participants and/or vendors.
- Prepare, contribute to and distribute presentation materials for meetings, newsletters and web-sites.
* these are document management systems. - alt-lib
Original post: Wilmington Study Associate Job - DE, 19801
Study Associate Job
- - Contribute to clinical study start-up, execution, close-out and reporting. - Collect, review and track regulatory and other relevant documents. - Interface with Investigators, Strategic Partners, Marketing Companies and internal staff during the collection process to support effective delivery of a study and its regulatory documents through finalization of the Clinical Study Report (CSR). - Initiate and lead the set-up of the Study Master File (SMF) including tracking of documents. - Maintain and close the SMF ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance. - Initiate and maintain production of study documents, ensuring template and version compliance. - Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the Authoring Guide for Regulatory Documents to support publishing in GEL. - Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards (i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities). - Plan and proactively collate the administrative appendices for the CSR. - Interface with Data Management Centre and/or Data Management Enablement representatives to facilitate the delivery of study related documents. - Provide input into non-drug project work including training activities and development of procedures as needed. - Set-up, populate and accurately maintain information in tracking and communication tools (e.g. IMPACT, ISSIS, Clinical Partners Portal and eRoom) and support others in the usage of these systems. - Manage and contribute to the coordination and tracking of study materials and equipment. - Coordinate administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs. - Lead the practical arrangements and contribute to the preparation of internal and external meetings (e.g. study team meetings, ISS review meetings, monitor meetings, Investigator meetings, etc.). - Liaise with internal and external participants and/or vendors. - Prepare, contribute to and distribute presentation materials for meetings, newsletters and web-sites.
- - Minimum 1 year experience. - Level of education that supports skills and capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers. - Proven organizational and analytical skills. - Previous administrative training/experience. - Computer proficiency. - Excellent knowledge verbal, written and presentation communication skills. - Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines. - Ability to develop advanced computer skills to increase efficiency in day-to-day tasks. - Demonstrate ability to work independently, as well as in a team environment. - Ability to prioritize and manage multiple tasks with conflicting deadlines. - Good interpersonal skills and ability to work in a team environment. - Willingness to travel both domestically and internationally. - Proactively identify risks and possible solutions. - Demonstrate analytical thinking, concern for standards, concern for impact, good team skills including cooperation, willingness to learn from others, sharing relevant information, adaptability, self-control, tenacity conflict resolution skills and the ability to influence others. - Develop knowledge of therapy area through experience and review assignment.
Recruiter: Daniel Barrett
Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn more about our company.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.