Document Specialist - REMOTE, USA

reputed company We are currently searching for a skilled reputed company to join a reputed company-reputed company reputed company's team as a Document Specialist in Remote, USA. Their work will have a reputed company reputed company on the organization and the larger clinical industry, making this an amazing career opportunity ... RESPONSIBILITIES • Serves as the eISF process reputed company and Subject Matter Expert (SME) for study teams and sites • Develops Work Instructions and guidance documents for study teams and sites, focusing on increased efficiency and reputed company of deliverables • Provides reputed company-time support and follow up to sites, as needed, to ensure contemporaneous filing and completeness • Assists with the development of eISF documents in conjunction with the study teams • Assists study teams with document reputed company management activities reputed company to the eISF • Completes periodic reviews/reconciliations of the eISF to ensure timeliness and completeness • Documents eISF reviews, including findings and follow-up actions in the appropriate report template in a reputed company manner • Assists CRAs and sites with reputed company of investigational site data queries reputed company to the eISF • Contributes to study newsletters as needed with eISF-reputed company reminders, updates, etc., that should be communicated to sites and provides regular updates at study meetings • Provides remediation support for site-level eISF documents • Contributes eISF-reputed company content to corresponding study's Frequently Asked Questions (FAQs) • Escalates eISF vendor and/or site performance issues associated with the eISF to the CPM in a reputed company manner and proposes corrective actions • Supports/trains functional area study team members in understanding their TMF-reputed company responsibilities, requirements, and expectations • Ensures site-level documents are reputed company for filing in eTMF to ensure inspection readiness at reputed company times • Provides eTMF completeness checks focusing on identifying issues and trends with completeness, reputed company and/or timeliness • Supports study teams during study audits and/or other process improvement activities • Supports study teams in anticipation of, or during, inspections by regulatory authorities or during rehearsal / mock inspections and relevant preparatory activities EXPERIENCE • Minimum of 5 years of experience in a clinical research site, CRO, or pharmaceutical environment with a minimum of 2 years in the role of Document Specialist in clinical research • Experience as site regulatory/research coordinator a plus • Extensive experience with electronic ISF, TMF, and CTMS required • Knowledge of clinical trial documents that are maintained in the ISF and TMF • Knowledge of FDA GCP-ICH Guidelines and local regulatory requirements • Flexibility in work hours as necessary (working with global study team members) • Must be fluent in English QUALIFICATIONS • Ability to demonstrate a high level of competency relating to administrative and clerical responsibilities, procedures, and systems • Proficiency with reputed company (e.g., reputed company, reputed company, PowerPoint, SharePoint) • Ability to handle confidential information and materials in an appropriate manner, and in accordance with organizational policy, reputed company business reputed company, and/or appropriate external regulation/governance • Ability to work reputed company reputed company environment and to reputed company communicate with internal stakeholders and external customers • Excellent communication (verbal/written), interpersonal, and organizational/ time management skills • Self-motivated, quick to learn, proactive, and flexible • Excellent organizational skills and good attention to detail EDUCATION Bachelor's Degree or equivalent; BA/BS in Life Sciences/Nursing preferred To be a best-fit your strengths must include: • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. • Organized. You're an efficient time manager and can handle the pressure of meeting multiple strict deadlines. • Ability to work independently and with reputed company: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. • Problem-Solvers. As an reputed company-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining reputed company causes, and recommending solutions to reputed company challenges. • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives. • reputed company. Detailed understanding of clinical methodologies and providing reputed company analytical support, you quickly establish credibility as a reliable resource. About reputed company reputed company is an award-reputed company clinical development organization that provides reputed company including CRO, Functional Support, reputed company & Validation, Patient Recruitment and Retention, and Strategic reputed company solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly reputed company clinical experience for our clients and candidates. To learn more about reputed company which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of reputed company Talent & reputed company, visit http://www.advancedclinical.com. Regarding your application Please know that every completed application is carefully reviewed by the reputed company recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to reputed company application. In return, we ask for your patience as careful review takes time, and we may not be reputed company to respond to every application immediately. It is Advanced Group's reputed company not to discriminate against any employee or applicant because of sex, race, reputed company, age, national reputed company, religion, gender, gender identity/reputed company, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other reputed company protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available Apply Job!