Document Specialist - REMOTE, USA

Overview

We are currently searching for a skilled professional to join a well-known client’s team as a Document Specialist in Remote, USA. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

Responsibilities

• Serves as the eISF process owner 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 quality of deliverables
• Provides real-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 quality management activities related 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 timely manner
• Assists CRAs and sites with resolution of investigational site data queries related to the eISF
• Contributes to study newsletters as needed with eISF-related 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-related 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 timely manner and proposes corrective actions
• Supports/trains functional area study team members in understanding their TMF-related responsibilities, requirements, and expectations
• Ensures site-level documents are sent for filing in eTMF to ensure inspection readiness at all times
• Provides eTMF completeness checks focusing on identifying issues and trends with completeness, quality 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 Microsoft (e.g., Outlook, Excel, PowerPoint, SharePoint)
• Ability to handle confidential information and materials in an appropriate manner, and in accordance with organizational policy, proper business practice, and/or appropriate external regulation/governance
• Ability to work within a team environment and to clearly 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 a team: 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 action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible. Detailed understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
  
  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical 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 each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis 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.

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