Records Management Specialist I Job in Cincinnati 45202, Ohio Us
job ID: 8015
Position Title: Records Management Specialist I
Working Location: Cincinnati, Ohio
Employment Status: Full-Time Regular
Required Experience: 2 years
Required Education: Associates Degree
Required Travel: 0
Job Summary:
Processes essential documents for inclusion in the Trial Master File (TMF), and manages study trial documentation from the completion of the regulatory start-up packet to study closure. Commonly performs a QC of post start-up documentation to ensure documentation is compliant with ICH/GCP, regulatory, and sponsor requirements. Collaborates with the project team to maintain an up-to-date and complete TMF through-out the life of the clinical trial.
Core Responsibilities:
Performs the following tasks with minimal error, within timelines, and according to RRM expectations, SOPs, work instructions, policies, and specific project or sponsor requirements:
•Receives and processes trial regulatory documentation from the point of site activation through study closure.
•Completes essential documentation QC assessing for completeness and compliance to regulatory guidance and INC Research/sponsor requirements.
•Collaborates with study team members regarding relevance, accuracy, and completeness of regulatory documents as necessary.
•Assists the Clinical Regulatory Specialists or other internal team members in the initial set-up of the tracking tool(s) and maintains with updates throughout the maintenance phase of the study if required.
•Tracks essential documents in tracking database using standardized naming conventions.
•Properly files hard-copy and/or electronic study documentation in the TMF/eTMF.
•Properly indexes electronic documents based on sponsor electronic filing requirements and sponsor index hierarchy, if required.
•Identifies documents with expiration dates per ICH/GCP, sponsor, and INC Research requirements and includes these documents with expiration intervals in the tracking tool.
•Collaborates with the study team to ensure all trial regulatory documents are collected and maintained in the TMF.
•Provides scanned or hard copies of regulatory documents per request of study team members.
•Returns sponsor TMF per INC Research SOP or sponsor requirements.
•Represents Regulatory Records Management at study team meetings and teleconferences. Collects information concerning study conduct from these meetings to distribute to other appropriate associates.
•Accompanies lead department staff at sponsor/audit meetings and interviews.
•Participates in audit processes regarding the TMF before, during, and after audit(s).
•Communicates any potential out of scope information to the department manager and/or Senior Regulatory Records Specialist.
•Provides training to the project team regarding TMF management.
•Assists in the completion of TMF Plans and other study plans as required.
•Assists project team members in the interpretation of TMF structure, coding, filing, and contents reports.
•Maintains up-to-date knowledge of study related information on projects.
•Communicates professionally and effectively with both internal and external customers.
•Maintains order of file room or storage space and supplies.
•Demonstrates resourcefulness in attempting to solve problems by reviewing project documentation, correspondence, and operating procedures before seeking assistance.
•Completes tasks within timelines by appropriately prioritizing multiple tasks within or across projects, minimizing backlog, and managing time constraints across projects, seeking direction from Senior Regulatory Records Specialist and management as required.
•Adapts to timeline or priority changes by reorganizing daily workload.
•Proactively communicates to RRM Management accurate estimates on time to complete tasks, availability to take on new assignments, downtime, and resourcing conflicts.
•Demonstrates customer-oriented communication skills responding to management and team correspondence promptly and within agreed upon timeframes, cooperating with requests and utilizing appropriate method of communication based on urgency and type of information being communicated.
•Prepares in advance for meetings, completes action items within required timeframe, and attends internal meetings regularly, providing input and demonstrating respect for the opinions of others.
•Interfaces with other INC Research departments and personnel as necessary to answer project questions and resolve data issues.
•Displays willingness to work with others and assist with projects and department initiatives as necessary to meet the needs of the business.
Skills Attributes:
It is preferred that the Candidate/incumbent should have an Associates degree and one to two years or equivalent relevant experience. An equivalent combination of education and experience may be accepted.
The candidate should also have demonstrated the following knowledge skills and abilities:
•Excellent organization, communication, record retention, time management, decision making, customer service and interpersonal skills.
•Basic knowledge of medical and pharmaceutical terminology.
•Ability to work on a team and independently when required.
•Proficient in the use of computer and software systems and have an understanding of basic data processing functions.
•Detailed data entry skills.
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