Records Information Specialist

Job Description:
JOB TITLE: Records Information Specialist
JOB LOCATION
Job Overview
The Records Information Specialist, in collaboration with global internal and external study team members, supports all phases of the study under limited departmental and/or study team supervision. Duties may include Trial Master File (TMF) processing, inclusive of essential document review, such as tracking, maintaining, collecting, and coordinating content. Supports multiple studies based on scope. Has strong knowledge of the department with ability to train and mentor fellow team members. May further assist Senior Records Information Specialist with delegated oversight tasks. Meets defined chargeability expectations for position.
Job Duties And Responsibilities
Manages the set-up and maintenance of General, Country and Site level artifacts within electronic TMFs (eTMFs) in accordance with the Company processes and study-specific plans
Supports regulatory inspections and/or audits as required
Reports all document collection and tracking issues to departmental management and/or study team on a routine basis
Proactively identifies, manages, escalates where applicable, and resolves document issues effectively and independently
Assists with final site TMF review and close-out list creation, communicates findings and provides feedback to applicable study team member(s)
Assists with study plan and core document reconciliation as required
Archives study documentation, works with eTMF vendor, and IT where applicable, to return TMF to sponsor as directed
Prepares and provides associated reports to study teams as applicable
Reviews, creates subfolders, and maintains project mailboxes
Conducts and documents Food and Drug Administration debarment, disqualified, and inspection lists as requested
Files according to the Company processes and/or sponsor requirements along with the Company quality standards adhering to <95% accuracy across the major file sections and documents contained therein
Assists in providing regular feedback to the project team on TMF health and status
Supports conduct of departmental meetings and/or trainings, as applicable
Provides support and guidance to all levels of Records Information Associate to complete assigned tasks
Assists all levels of Records Information Associate to resolve opendocument queries within eTMF
Serves as mentor and onboarding trainer to departmental new hires, may assist with coordination of training by other functional areas
Conducts other duties as assigned by departmental management (e.g. Manager, Director)
Supervisory Responsibilities
No supervisory responsibilities.
Job Requirements
EDUCATION
College/University graduate preferred, healthcare or life science degree a plus
Equivalent combination of education and relevant work experience considered
Experience
Approximately 3 years in records management or relevant clinical operations role
Skills/Competencies
Strong English language written and verbal communication skills
Strong interpersonal skills
Team-oriented and a strong team player
Strong computer skills, including Microsoft Office
Interest in learning medical terminology
Knowledge of GCP/ICH guidelines
Exceptional attention to detail
Highly organized
Able to work in a dynamic, changing environment
Demonstrates honesty, trust, fairness, cooperation, self- control, and flexibility
Ability to work and perform tasks independently
Capabilities
Minor lifting,
Office based preferred

Work arrangement
No