Records Information Specialist

JOB TITLE:  Records Information Specialist

JOBLOCATION

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,<30 lbs.
• Office based preferred