Records & Document Management Specialist I

Job Description

Primary ResponsibilitiesAssisting in maintaining the corporate Electronic Document Management System ( EDMS ) by: Creating, deleting and updating user accounts to reflect personnel changes including role assignments. Assisting global end-user support both remotely and in-person for basic EDMS trouble-shooting such as lockouts and user credential verifications. Providing basic EDMS training and guidance to staff regarding the use of the system. Assisting in EDMS integration activity by revising documentation, courses, users, roles, grandfathering and basic EDMS activity as necessary. Updating and maintaining document tracking such as Table of Contents and SharePoint sites based on relevant documentation. Revising and creating controlled documentation and placing into appropriate templates according to the SOP on Controlled documents.Collaborating with authors on documents, attachments, forms and templates that are out-of-compliance or in need of revision.. Identifying opportunities for document Retirement, preparing the Document Retirement Form and obtain signatures. Archiving document in the EDMS and other tracking mechanisms. Preparing and assisting in audits by providing requested information, producing and interpreting reports as required, and providing administrative support. Identifying opportunities to improve the end-user experience for EDMS and Document Management proceduresSecondary Responsibilities Maintain quality service and departmental standards by Reading, understanding, and adhering to organizational standard operating procedures (SOPs) Assisting in establishing and enforcing departmental standardsContribute to team effort by Working with internal staff to resolve issues Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Performing other duties as assignedMaintain technical and industry knowledge by Attending and participating in applicable company-sponsored trainingQualificationsEducation High School Graduate or Associate/Bachelors Degree in bioscience, computer science, information technology or related field preferred Bachelors degree preferredExperience 1 years experience working with an electronic document management system (EDMS) Working knowledge of GCP, ICH guidelines and FDA regulations. Intermediate to advanced knowledge of Microsoft Office and SharePoint preferred Ability to prioritize requirements and delegate tasks to meet goals Excellent organization and time management skills are required to manage multiple projects simultaneously Able to work independently and provide support to others Self-motivated, flexible and adaptable to business needs.Additional Skills Strong motivational skills and abilities, promoting a team-based approach Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills Goal-oriented Ability to maintain professional and positive attitudeWorking conditionsTravel: 0-5%Lifting: 0-25 lbs.Other: Computer work for long periods of timeEEO StatementBioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.Collaboration, Continuous Learning, Courageously CuriousOur appetite to blend the best of domain expertise, technology and human understanding knows no bounds. Were relentless in pursuing the information, insights and inspiration that means we can continuously improve clinical trial site support services and technology solutions.Behaviors:We learn; embracing change, questioning how we work, finding a better way. And if it doesnt go to plan, we dont blame each other; instead, we own it and grow together We partner with each other, with customers, patients and sites, working with them to understand their goals and then deliver the best solutions, Critical Thinking, Deliver ExceptionalWe step forward because responsibility powers us; we dont leave others to do what we can do ourselves. We take charge of events, delivering exceptional work for our customers, patients and each other.Behaviors:We prioritize; focusing on what matters, never compromising on quality. We commit; delivering what we say we will, working with energy and intent, sharing what we learn with each other., Organizational Awareness, People first, alwaysWe think of others before we think of ourselves. We have a deep understanding of our customers, and deep empathy for patientsand each other. Were united by our purposeits why we go above and beyond to support each other, emphatically.Behaviors:We do the right thing; for our customers, patients, sites and each other. And Were passionate about it. We lift each other up; respectful of different views, we listen are inclusive, and support each other to succeed., Results Orientation, Service Orientation,

Keyskills :
SharePointArchivingMicrosoft OfficeGCPTime managementLeadershipInterpersonal communicationElectronic Document Management System EDMSEDMS troubleshootingEDMS integrationControlled documentsDocument trackingAuditsICH guidelinesFDA regulations