職位描述
Investigator Support Associate
Job Summary:
Responsible for the archiving and retrieval of documentation generated by the company to maintain an audit trail required by regulatory bodies and customers.
To effectively process archived materials in accordance with company policy and Standard Operating Procedures (SOPs) assisting to ensure Archive Systems and Facilities are maintained in compliance with Good Clinical Practice (GCP).
Ensures that relevant services to both internal and external customers/regulations are provided in a timely manner.
Essential Job Duties:
Manage the day to day running of the archive facility.
Ensures company procedures are followed with regards to security and access to the data to prevent tampering or loss of data in Archives.
Is competent in all procedures relating to materials submitted to archives and provides assistance as required.
Is competent in the archive index systems to ensure the efficient retrieval of archived data and withdrawal of records and assists with the monitoring for the return of data, advising line management of any anomalies.
Where appropriate manage records for offsite storage
(*) Assists in all procedures relating to the efficient disposition of archived materials that ensures client or Test Facility Management requirements are established and processed accordingly in-line with appropriate regulations, contacting clients on an infrequent basis.
(*) Consistently demonstrates good customer service skills and judgment and solves internal customer issues with minimal management input.
“*” May on occasions hosts client & regulatory tours of the archive, answering questions on the storage of data.
(*) Contributes through disposition processes with raising departmental revenues.
Leads project assignments associated to archives (eg. Process Excellence).
Assist with producing departmental metrics for review and analysis.
Performs archive staff training and development as appropriate for role.
Assists with writing and maintaining local/regional SOP’s with respect to archiving and ensures adherence to companies Global/Regional/Local SOP’s as appropriate.
Assists with the monitoring of environmental conditions and archive facilities for the preservation of various types of data in the archives advising management of any issues.
Complies with relevant Environmental, Health and Safety at work regulations and Company Policies.
Cooperates and maintains good relationships with other groups
Perform such other duties as are required from time to time.
Manage local SOPs, local General and QA Forms ensuring they are appropriately reviewed, signed, distributed and communicated.
“*” Denotes potential for client interaction
Education / Qualifications
Level of education required (or experience level which may be substituted for level of education).
Professional designations/certifications/licenses required
Associate degree or equivalent with 3 years of work experience. Bachelor of Science/Arts (BS/BA) degree is preferred.
Experience may be substituted for education. For example, a High School Diploma or equivalent plus 5 years directly related experience may be substituted for an Associate degree
Good knowledge and ability to interpret GLP, GCP and cGMP's Regulations in relation to archiving and records management as applicable for site.
Ability to positively interact with clients and regulatory personnel
Good customer service skills
Ability to perform good basic computer skills (e.g., Word, Excel, PowerPoint,)
Experience
Minimum Required:
