Clinical Trial Associate
Theorem Clinical Research - King of Prussia, PA

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TRAINING AND EXPERIENCE −
Associate or 4 year degree in related science or business, or equivalent experience preferred; High school diploma required. −
2 years experience working within a cross−functional environment. Demonstrated ability to successfully interact with
sponsors/customers. Experience in successfully meeting team deliverables. Minimum 1 year experience in clinical research; proven
mentorship preferred. Experience with Microsoft Word, Excel, Project, Access and PowerPoint is required. −
Communicate fluently in English, both verbally and written. −
Interface with company personnel. −
Interface with study sites. −
Ability to travel independently by air, care and/or train (travel less than 5%).

KEY SKILLS & BEHAVIORS −
Strong organizational, interpersonal and communication skills, with a high degree of accuracy and attention to detail. −
Ability to multi−task with strong time management skills, ability to prioritize and meet aggressive deadlines. −
Ability to work independently with minimal supervision. −
Ability to maintain high level of confidentiality and take instruction from numerous sources.

Job Description:
JOB SUMMARY
Works with the Project Management team under the direction of the Senior Manager, Site and Study Support Services and/or Project
Lead to conduct the processes associated with project support, including the management of documents, in accordance with the
Company and client expectations and standards including SOPs and FDA/ICH guidelines and regulations. Mentor and assist with
training.

JOB RESPONSIBILITIES −
Assist with training and mentoring: new hires and current team. −
Conduct investigator recruitment and essential document collection activities as assigned, including review and tracking activities. −
Submit investigators to central IRB, as applicable. −
Review site specific informed consent forms against required elements and work with mentor to finalize with internal team, sponsor
and site. −
Receive, review, track/inventory and appropriately file within project master file or deliver to sponsor all documents from internal team,
sponsor and sites. −
Prepare, maintain, return/archive project master file as applicable. −
Perform project master file reviews as outlined in project specific plan and applicable. −
Request, manage, distribute and track study supplies; including Investigator Site Files. −
Update and maintain study−specific trackers and systems under direction of Project Lead. −
Coordinate, set up, and attend project meetings including: internal, CRA, client meetings and presentations. −
Provide administrative support for project teams including: mass mailings, mass email distributions and newsletters per contract
specifications. −
Assist with distribution and processing of protocol amendments, IND Safety reports and investigator brochure updates to sites. −
Assist in identifying and implementing best practices and continuous improvement plans within the department/company. −
Maintain working knowledge of the Company’s standards/SOPs and FDA/ICH guidelines and regulations.

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About this company
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Theorem Clinical Research is one of the foremost providers of comprehensive CRO services with offices in more than 30 countries and a...