Clinical Contracts Associate - II in Foster City, CA at Integrated Resources, Inc

Date Posted: 5/13/2021

Job Snapshot

Job Description


**Local to the Bay Area Candidates Only, no remote candidates**

General Position Summary / Purpose:

The Development Business Operations Associate II in the Document Management Team (DMT) will collaborate with Development Business Operations functional groups, Clinical Records and Clinical Operations study teams in the planning, development, and implementation of standards, processes, and projects for DMT designed to ensure the effective and efficient archiving of clinical agreements and related information created in support of clinical research. Comply with relevant regulatory, legal, country specific and corporate requirements to produce and maintain inspection readiness for clinical records.

Key Accountabilities / Core Job Responsibilities

Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical agreements
Collaborate with Development Business Operations functional groups, Clinical Operations study teams and functional areas outside of Development Business Operations to ensure compliance with policies, procedures, and the practices of Clients records management/TMF archival initiative
Work with management and DMT personnel in the development, implementation and maintenance of classification and filing systems to meet administrative, research, regulatory, legal, and financial requirements (e.g. filing of agreements in Client legal archive, Apttus, and eTMF GDAR and Veeva)
Work with management to manage business continuity procedures, including management of paper agreements
Perform central intake activities including creating records of incoming documents within the first business day of receipt, filing of incoming documents, and retrieve copies of paper protocol agreements from TMF room for Apttus filing
Collaborate with management to establish and generate central intake reports
Responsible for keeping DMT Master Inventory up to date and accurate
Evaluate regulatory and Client business recordkeeping, archiving requirements, and organizational objectives and ensure Development Business Operations DMT is aligned with all
Responsible for the continued maintenance of eTMF (GDAR) and Apttus contract filing
File incoming documents in both electronic and paper format
Ensure record filing is kept up to date and is performed accurately by DMT members
Develop and maintain department process guidance, training materials, policies and procedures, and other quality documents
Define and manage processes associated with the storing, archiving, indexing, scanning, and classifying records
Manage the off-site storage of records for Development Business Operations agreements and collaborate closely with Client Clinical Records team to ensure proper process is in place for off-site archival of paper agreements
Collaborate and partner with the Information Technology (IT) GDAR and Veeva Teams, through stellar communication and solid project management. Resolve efficiently any issues encountered by collaborating with IT in the improvement of processes, procedures, and effective use of available information technologies
Develop into the Subject Matter Expert (SME) in the electronic TMF (eTMF) filing process, especially in Veeva
Respond to internal and/or external information inquiries related to contract filing and records retention of those agreements; supports internal and external audits and inspections, including provision of data on contract filing
Manage the DMT mailbox by responding to daily email inquiries, review of incoming agreements for technical review and uphold the contemporaneous filing requirements and SLA turnaround time in eTMF (GDAR and Veeva) and Apttus
Participate in the development, implementation and maintenance of internal systems and processes used to manage collections of agreements and filing of documents to GDAR, Veeva and Apttus
Track and maintain departmental metrics related to operational activities, progress of contract filing and archive, quality measurements and other variables. Develops appropriate tool sets for capturing metrics and generating reports.
Responsible for the day-day activities associated with the quality check of clinical agreements and management of contract filing and archival
Ensure appropriate documentation completed to track archival of files
Support Development Business Operations Functional Teams and Clinical Operations Study Teams in understanding TMF-related responsibilities, requirements and expectations
Manage Development Business Operations TMF protocol list for legacy and active protocols and Development Business Operations TMF Comprehensive Review Trackers and Agreements Missing in TMF
Provide management with DMT metrics; completeness and quality of TMF documentation and content, including the percent completeness and risk level of outstanding items on a periodic and/or ad hoc basis as requested by management

Qualifications / Requirements
3-4 plus years of project or clinical trial coordination/management experience
3 plus years of Clinical Research Associate (CRA) or relevant records management/ TMF management experience equivalent experience preferred
Exemplary interpersonal skills with proven demonstration
Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and GCP guidelines related to Clinical Document Management
Proficiency in MS Project and standard desktop tools including, but not limited to, MSWord, Access, PowerPoint, Visio, and Excel
BA/ BS required