[Hiring] Clinical Records Associate @4D Molecular Therapeutics

Role Description

We are seeking a Clinical Records Associate for our TMF Operations Department Reporting to the Associate Director of TMF Operations. This position is responsible for collecting, reviewing, maintaining, and archiving essential documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and 4DMT’s Standard Operating Procedures (SOPs) as appropriate.

Qualifications

• A./B.S. degree (preferably in a scientific or healthcare-related field) preferred
• High school diploma required
• A B.S. with 2+ years relevant experience including extensive experience with Veeva Vault TMF or a H.S. diploma with 6+ years relevant experience.
• 2+ years of TMF QC Review and knowledge of clinical documentation content required.
• Experience working with cross-functional teams to improve TMF compliance (quality, completeness, and timeliness)

Requirements

• Knowledge of and ability to apply applicable regulations and guidelines (e.g., ICH/GCP/Good Documentation Practice).
• Expert knowledge of cross-functional TMF content requirements throughout the trial.
• Proficiency in Microsoft Office Suite for collaboration with team members.
• Especially proficient in Excel for tracking, sorting, filtering, and managing large sets of metadata.
• Excellent communication skills (written and verbal).
• Interpersonal skills, including conflict resolution in a fast-paced, deadline-driven environment.
• Strong attention to detail and organizational skills.
• Ability and drive to follow through on detailed tasks to closure.
• Analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
• Development and maintenance of TMF Plans.
• Demonstrated understanding of the DIA Reference Model filing structure and contents.

Benefits

• Base salary compensation range: $92,000 - $116,000
• Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.