DEPARTMENT: Quality Assurance
REPORTS TO: Department Management/Supervisor
Responsible for providing study and facility document/records management. Provide support and guidance to departments to ensure all study and facility data is inventoried and stored to meet internal, external and regulatory requirements. Ship and retrieve study and facility data from archives facilities. Assist in the filing, distribution and processing of technical documents and reports and study specimens. Assist with formatting, finalizing and distribution of technical documents, standard operating procedures and reports. Other duties as needed to support document records management.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The essential functions include, but are not limited to, the following duties. Various tasks may be assigned under each essential function. Those that are listed under the examples of work are not all-inclusive; they are examples only and may be amended or added to as needed by the organization.
- Good organizational skills. Create and revise quality documents as related to data shipments.
- Prepare and ship study and facility records to designated archive locations.
- Good oral and written communication skills (internal and external clients); interaction across functional areas by email, phone, or face-to-face.
- Maintain chain of custody (COC) documentation. Commitment to quality and pride in work. High attention to detail.
- Assist in interdepartmental collaboration/training to ensure effective data and document flow/transitions/storage/shipment. Ability to work with members of all levels within the organization.
- Communicate with study directors/principal investigators etc. related to shipping and from designated archive locations.
- Plan, organize, and maintain inventory processes. Must be able to complete assigned tasks independently with minimal instruction and have the initiative to obtain guidance on assignments when needed.
- Clerical duties include but are not limited to filing study and facility data, copying, distribution of technical documents. • Indexing and organizing and alphabetizing files, material or data.
- Comprehend and process information rapidly and accurately.
- Maintain harmonious business/working relationships. Perform all aspects of job in a way that supports company brand and supports company mission, vision and values.
- Other duties as assigned to support company needs.
- Education: High school diploma or equivalent. Bachelor’s degree preferred. Exceptional experience in a related field could substitute for the education requirement.
- 1-2 years’ work experience related to documentation and computer systems.
- Working knowledge of MS Office, MS Access and Adobe.
- Understanding of relevant regulatory policies and documentation requirements.
- Strong knowledge records and media storage requirements, scanning/copying.
- Must be able to lift/reach heavy items (60-70 lbs) and sit/type for long periods of time.
- May be required to work overtime and weekends.
- Areas with moderate noise possible and exposure to hazardous/noxious devices (e.g., needles, scalpel blades, etc.) and chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc.).
- General office working conditions, with moderate noise.
All employees are required to satisfactorily perform the essential duties and responsibilities of their position. • The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
If you are interested in this opportunity please send your CV to email@example.com.