Clinical Project Assistant

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General Position Summary:The Clinical Project Assistant (CPA) provides support to the clinical study teams in the execution of clinical trials. Under the direction of the Clinical Project Associate, CTM or Study Lead, the Sr. CPA's primary responsibilities include maintaining Trial Master File (TMF) and Clinical Trial Management System (CTMS) in an inspection-ready state, assisting with site management, initiating collection of and reviewing and tracking essential documents throughout the life of the trial. This role contributes to the production and distribution of study materials and site/study communications. Key Accountabilities/ Core Job Responsibilities:Study Planning and Conduct:- Assists clinical operation leads in the development, handling, distribution, filing and archiving of essential documents in the TMF- Assists and/or contributes to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans, study communications and presentations- Handles incoming and outgoing clinical trial related materials shipments to site, study team, CRAs and vendors, as needed- Facilitates site vendor setup, debarment checks, and CDA and site agreement submissions- Assists with all aspects of initial study drug release including regulatory packet review and study-drug release- Assists clinical study team with the planning, preparation, and on-site support of investigators meetingsAssists in the development of case report forms and participate in the EDC and IXRS specification process, as appropriate- Communicates directly with sites, Site Management Organizations (SMOs), Contract Research Organizations (CROs) and field CRAs to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close out activities- Ensures timely study entry and updates to and maintenance of 'Clinicaltrial.gov' and until end-of-study under supervision- Conduct study tracking support (eg, CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates, as requested- Assists with final sign off of project and study-related documents including: informed consent forms, monitoring plans, synopsis, protocols and amendments, and other documents, as required- Participates in clinical team activities, including attending required meetings, and interacts in a positive, professional manner. May coordinate meetings/teleconference/WebEx, prepares agendas, minutes, and tracks action items- Ensures required corporate training on standard operating procedures, policies, work instructions are completed by the due date- Identifies and escalates issues appropriately- Performs other work-related duties as assigned About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffingu00ae Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please **** or email **** for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.nn 

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