McInnis Inc

Trial Master File Records Specialist (TRS) Responsibilities. The TRS will provide services onsite (hybrid position) at our Ridgefield, CT location supporting our Trial Master File (TMF) team.. The TRS is responsible to provide operational expertise to trial teams and Trial Documentation Service (TDS), oversees the implementation of the TMF strategy for the trial and supports the core trial team in all aspects of TMF management, in inspections or audits and in continuous improvement projects.. Support CAPA Leads in the development of actions and follow-up on assigned actions in the TMF area. Expertise in TMF Reference Model and Document management system

specialist

Hybrid Position - Weekly Commute to Ridgefield, CT & Work from Home
Trial Master File Records Specialist (TRS) Responsibilities
The TRS will provide services onsite (hybrid position) at our Ridgefield, CT location supporting our Trial Master File (TMF) team. The TRS is responsible to provide operational expertise to trial teams and Trial Documentation Service (TDS), oversees the implementation of the TMF strategy for the trial and supports the core trial team in all aspects of TMF management, in inspections or audits and in continuous improvement projects.
Duties & Responsibilities:
As part of the TMF team, the TRS will:
Manage the workload for assigned trials (approx. 12-18)
Supports the CT Leader by providing and maintaining oversight and guidance related to TMF activities throughout the course of the trial
Collaborates with the core trial team and the LTRS to create, implement and maintain the list of trial-specific expected records throughout the course of the trial
Perform regular reviews for completeness, timeliness, and quality of the TMF during CT conduct and provide feedback to the responsible party.
Facilitate communication between the trial team and LTRS
Create the final list of trial, country & site-specific exceptions with input from LTRS in all OPUs.
Inform the CT Leader about the list of exceptions
Confirm the archiving prerequisites have been met to support archiving.
Provide input into the TMF Operational Plan and TMF-related CRO processes for fully outsourcing trials
Support CAPA Leads in the development of actions and follow-up on assigned actions in the TMF area
Work on assigned projects in regard to continuous improvement
Experience and Skills Requirements:
4 Year college degree with 2+ years of TMF experience and/or 5+ years of TMF experience
Strong communication skills
Proficiency in computer skills, with direct working experience in multiple electronic platforms such as but not limited to: Share Rooms, Clinical Trial portals, Central IRB portals, Time reporting portals, Learning portals, Access Databases, Microsoft Excel, Microsoft Skype, Adobe Acrobat Professional and scanning software etc.
Maintain expertise of currently assigned Sponsor SOPs, Working Instructions (WI) and where applicable, departmental practices.
Maintain current knowledge of ICH, GCPs, applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets, PhRMA code, and industry standards for the monitoring of clinical trials at no cost to Sponsor.
Expertise in TMF Reference Model and Document management system
Experience working in an international/intercultural/cross-functional environment
Excellent time management with the ability to prioritize
Be a highly motivated individual with the ability to think critically, that is detail oriented, can multi-task and understand the clinical trial process, meet deadlines, and keep a trial /site on track along with any other qualifications provided by Sponsor
Records Retention/Storage
All documents managed by TRS will reside solely as electronic files in our systems and must remain within those systems with no local storage of documents outside of our firewall.
Additional Provisions:
Contractor will comply with the following Key Performance Indicators (KPIs). Both parties will mutually agree on metrics requirements and turnaround times.
LOS Compliance
TimeRecorder Compliance
Job Type: Full-time
Salary: $32.00 - $36.00 per hour
Benefits:
Dental insurance
Health insurance
Paid time off
Vision insurance
Schedule:
Day shift
Monday to Friday
Education:
High school or equivalent (Required)
Experience:
TMF: 2 years (Required)
Work Location: Hybrid remote in Ridgefield, CT 06877
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