Grifols Shared Services North America, Inc Clinical Trial Associate III in Clayton, North Carolina
Clinical Trial Associate II/III
Searching for an experienced Clinical Trial Associate that will provide administrative/clinical support on assigned projects/programs, while ensuring that the project/program needs are met within timelines established. This individual will be an expert with eTMF and document management (filing, reviewing and reconciling of the files).
Primary Responsibilities for role:
● Assists the clinical team in daily study operations which includes tracking of documents, special projects, distribution of safety reports, and preparing meeting minutes from internal project meetings. Coordinates meeting scheduling, draft meeting agenda.
● Maintains project related trackers and provides this information to study manager.
● Maintains clinical trial management system (CTMS). Creates studies within the system per SOPs, tracks study specific data, and generate reports.
● Assists in the distribution of key clinical study documents such as investigator brochures, protocols, informed consents, and regulatory submissions.
● Receives and tracks regulatory documents from clinical sites and CRO.
● Submits and tracks essential documents to the Trial Master File (TMF) on an ongoing basis.
● Files clinical trial documents for ongoing projects and assists in the archival of CRO study files and legacy documentation.
● Coordinates logistics of study related meetings including medical expert meetings, investigator meetings, and kick off meetings. Assists in project travel plans, reservations, and expense reports, specific to meetings wherein they were responsible for l
● Assists in the preparation, quality review, and publishing/distribution of key clinical study documents such as informed consent documents, essential regulatory document requirements, study manuals, investigator brochures, protocols, clinical study repo
● Obtains, tracks, and maintains, applicable CRO SOPs and subsequent revision versions throughout study.
● Coordinates the setup, filing, maintenance, and periodic review of TMF and project electronic filing system throughout the study.
● Assists with the development and maintenance of Microsoft Project timelines.
Receives and reviews regulatory documents from clinical sites and CRO to ensure completeness and accuracy (i.e. 1572s, financial disclosures). Develops, implements, and maintains effective processes, tracking tools, and communication with internal and external customers to increase project and departmental efficiencies. Coordinates documentation, tracks and assists in the management of clinical study supply releases (i.e. study drug, ancillary supplies), ensures regulatory is provided with appropriate documentation of approved investigator sites which will allow centers to be opened. Reviews TMF and Clinical Development documents for completeness and accuracy throughout the project. Oversees progress of CRO in the collection of essential documents during study start-up. Develops essential regulatory document tracking requirements for CRO. Sets up CTMS for assigned studies as directed, acts as "super User" for assigned studies, enters data as needed, reviews data for consistency, and trains new personnel on use of CTMS. Manages vendors and associated data. Manages vendor and site CDAs, contracts, and payments throughout the study. Follows up on study progress, and coordinate updates and/or retrieval of appropriate regulatory documents throughout the study.
Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Excellent knowledge of therapeutic area assigned. Excellent knowledge of ICH/GCP Guidelines and EDC process. Excellent verbal and written communication skills. Ability to train others in using MS Office Suite, Impact, and EDC systems. Ability to meet deadlines, multitask, and prioritize based on study needs. Ability to make sound decisions based on available information. Ability to establish rapport with site personnel/ colleagues. Ability to work both in a team and independently. Ability to facilitate team meetings and teleconferences. Ability to present at internal study team meeting (s). Ability to train and mentor junior CTAs. Ability to seek new learning opportunities within and outside of the assigned project. Ability to travel (international and domestic) up 25%, depending on project needs.
Clinical Trial Assoc II: 4 years’ experience as a clinical trial Associate.
Clinical Trial Assoc III: Associates Degree in a life science field required. Bachelor’s degree in a life science field preferred. Plus 5 years of experience as a clinical trial associate with knowledge / Minimum experience of the CRA role.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and / or competencies may be considered in place of the stated requirements.
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck and waist. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Drives: varies may or may be required to frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs tasks by following a set of written or oral instructions/procedures.
Req ID: 167767