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Note: This is a hybrid role with on-site working required up to 3 days per week on-site at the customer office.
Purpose
Supports in the administration of Clinical Records Management, ensuring compliance with all appropriate Records Management policies and procedures as well as Records Retention schedule.
The role is intended to maintain the operations of the physical records room(s) regarding archiving, indexing and retrieval of critical and non-critical physical records and so on site work at client site will be required. This also includes the management of off-site records storage activities.
Key Activities
Supports the administration of the Clinical Records Management Programs ensuring records are managed and maintained according to company policies and procedures, departmental policies/procedures and in accordance with defined retention times and legal holds.
Provides guidance to maintain the integrity of the archived records. This includes working with staff to determine the best options for their needs—including but not limited to developing and maintaining tracking sheets that fit each document collection and determining the most appropriate location for the physical records (on site or offsite) and the appropriate system for the archiving of scanned/electronic imported records.
Archival and indexing of critical and non-critical physical records including processing, maintaining, and tracking document collections. In addition, provides guidance on assisting staff with record searches and retrieval requests.
Archives the Clinical Research physical records stored at external vendors and is the primary contact for offsite storage and retrieval of records.
Oversees management of the on-site clinical records room and is the primary contact for on-site and timely access of records.
May support and facilitate records access requirements during regulatory inspection in collaboration with Clinical Document Management and Trial Support and applicable functions.
Actively manages and maintains the electronic archive database including working with vendor on implementing or updating system.
Execution of inventories of physical records according to requirements outlined in Clinical Records procedures.
Satisfactorily completes all required training in conformance with departmental requirements.
Performs other duties as assigned associated with records management initiatives.
Required Skills & Experience
4+ years' experience in pharmaceutical industry, clinical research organization, or records management related role preferred.
2+ years of Trial Master File (TMF Management) experience is required
Awareness of regulatory requirements for clinical trials (ICH/GCP) pertaining to records management preferred
High level of understanding of the use of Microsoft Excel and other Office products
Demonstrated ability to work with reasonable independence, take initiative, complete tasks to deadlines
Strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlines
Good communication skills and customer focus
Good organizational, interpersonal and problem solving skills
Proven ability to communicate effectively and responding to inquiries and concerns
Experience with use of electronic Records Management Systems preferred
Demonstrated ability to be flexible and to adapt quickly to change
Good teamwork, organizational, interpersonal, and problem solving skills
Fluent business English (oral and written)
Able to lift and move boxes of documents
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora
Full time*This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
.