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Clinical Trial Associate Resume Samples
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0-5 years of experience
- Participated as a clinical team member in the execution of blood testing and virology assay trials to fulfill program goals and timelines in accordance with company objectives (US & ex-US studies)
- Assisted seven clinical study teams in the execution of clinical trials, including the following activities: developed and maintained tracking tools, prepared minutes from meetings, prepared mailings to investigational sites, assisted with investigational site payments and budget oversight, inputted drug orders, randomized patients, and performed other study specific projects per the needs of the study team
- Ran patient status, trackers, and central files inventory reports for Clinical Research Associates
- Submitted study pertinent documents to Institutional Review Boards (local and central)
- Maintained study website, ClinicalTrials.gov, and Investigator Database
0-5 years of experience
- Collects, distributes and tracks receipt of regulatory documents and other trial related documents through the life cycle of the clinical trial as needed.
- Compiles key study information from various systems into a report format for tracking and trending metrics for study team.
- Creates and maintains logs of trial related documents. Distributes and tracks CIOMS reports to clinical trial sites and IRBs.
- Distributes and tracks protocol deviations. Distributes, tracks, collates and summarizes feasibility information and provides to study team as needed.
- Ensure compliance with the application and communication of all Novo Nordisk
- Generates potential site information from investigator database. Maintains trackers for essential trial related documents as needed.
- Provides administrative support to study team as needed for trial related tasks. Responsible for ensuring that the mandatory trial entries are made in novoDOCs, TMF, IMPACT and other relevant systems.
- Ensures that clinical trial documents are filed/uploaded accurately and within expected timelines.
- Responsible for properly coding clinical trial documents for archives for the life cycle of the clinical trial, and assures that documents are sent for archiving on a regular basis.
0-5 years of experience
- Conduct reconciliation of critical documents for phase 3 US and Ex-US studies involving 20 countries and 600 sites.
- Ensure FDA inspection readiness for study support activities and study documents.
- Track all documents received in tracking system.
- Communicate with clinical sites regarding documentation issues and discrepancies.
0-5 years of experience
- Maintenance and coordination of the logistical aspects of clinical trials according to GCP and ICH relevant SOP’s.
- Act as a primary contact for the clinical trial team supporting the Lead StM/ PM
- Execute the technical aspects of all site regulatory documentation and compliance during the conduct of clinical
- Participation as an active member of the project team
- Assess and put in place action plans to ensure project deliverables are met according to agreed timelines and milestones and quality expectations
- Supports implementation of technology enabled processes and identifies new technology solutions to improve
- Develops effective and productive partnerships with strategic business partners as well as client team members to ensure clarity of role, deliverables and achievement of project goals and objectives.
- Supports the internal function for data cleaning for both paper and Electronic Data Management or other electronic
0-5 years of experience
- Process eRoom requests; request documentations to process eRoom request; sort clinical research documents and arrange them properly into assigned folders
- QC TMF and ensure that they are completed properly by authorized study personnel; recognize any inconsistencies or inaccuracies or missing things within the TMF, and send these reports to CRO’s / Vendors with authorized study personnel for solution.
- QC and generate folders for the TMF file structure in the collaboration sites (eRoom / SharePoint) for the CT, Country and IS level sites to upload documents as per study protocol.
- Prepare Coordinate, review and finalization of various clinical operations/trial-related documents (i.e., Trial master file, protocols/amendments, informed consent forms, Study operations manuals/sheets, advertisements, data management/analysis plans and clinical study reports) according to ICH-GCP guidelines and CFR Part 11 for completeness, accuracy and legibility.
- Co-ordinate and conduct study initiation tasks such as preparation of study binders and study startup documents and sending out to multiple sites, review and file site approval documents, drug accountability logs and assist in site close out activities.
- Attend meetings for various therapeutic areas at global level via teleconference / video conference to address immediate TMF issues according to priority.
- Assess adverse drug reactions and files related reports as per FDA guidelines.
- Assist in external audits from regulatory bodies.
- Undertook other duties as delegated by senior management.
0-5 years of experience
- Collaborate with trial managers to gather documents for the trial reference manuals.
- Generate and maintain regulatory document tracker and the trial physician (MD) list of selected sites.
- Create new contacts and accounts as needed for centers. Create trial contact list.
- Request Intralinks workspace in order to: set-up investigator listing, create comment threads, distribute templates and trial related material, and publish regulatory documents.
- Perform quality review, process, and track documents in the Trial Master File.
- Contact site coordinators and monitors to resolve any issues.
- Collaborate with trial managers, sites, and monitors to resolve regulatory documentation issues.
- Create regulatory document by pre-populating templates for site use.
0-5 years of experience
- Supporting the clinical team (clinical research associate, study manager, and other clinical operations staff) with administrative duties.
- Experience with feasibility, start-up, maintenance, and close-out.
- Responsible for conducting day-to-day clinical/regulatory in-house study administration, collection, review study files for accuracy and completeness, tracking and archiving Amgen study regulatory documents into CTMS (Epic and Veeva Vault).
- Initiating, maintaining, and reconciling Trial Master File.
- Assisting in reviewing ICF.
- Co-monitoring visit with primary CRA.
- Preparing the regulatory binders and IPIM binder for the clinical studies.
- Distributing communications to all sites.
- Taking meeting notes and distributes meeting minutes.
- Liaise with the investigators and site staff via telephone and e-mail regarding problems.
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Clinical Trial Associate
Last edited by: Gabriela Barcenas, CONTENT STRATEGIST -
Gabriela Barcenas
CONTENT STRATEGISTGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
