Summary of the Position:
The TMF Specialist II is responsible to complete quality reviews of trial master file (TMF) documents for the purposes of audit and regulatory and health authority inspection readiness, and for ensuring compliance as determined by FHI Clinical processes, trial sponsors, and the applicable institutional policies from the startup phase through the contractual end of the study.
Essential Functions:
Responsible for paper Trial Master File (TMF) set-up, maintenance, and updates per FHI Clinical processes, sponsor requirements, and applicable regulations.
Responsible for electronic TMF system maintenance and updates per FHI Clinical processes, sponsor requirements, and applicable regulations.
With minimal supervision, support TMF audit and inspection readiness by conducting TMF/eTMF content quality reviews at defined time points, collaborating with internal team members, providing periodic updates, ensuring that FHI Clinical privacy and security standards are met and adhered to, and verifying study specific information on a regular basis.
Assist with maintaining up-to-date study status tracking and other tracking tools (as assigned).
Assist the TMF Lead in the TMF Plan review.
Assist the TMF Lead with archival and destruction activities, as needed.
In conjunction with TMF Operations management, participate in define and implement organizational process improvement activities to increase efficiencies and provide recommendations for remediation, as required.
Provide assistance to those in the TMF Specialist I and TMF Coordination role.
Interviewing and conducting technical proficiency testing of potential TMF Operation group candidates
All other duties as assigned.
Knowledge, Skills and Abilities:
Must have data entry experience.
Experience with TMF and strong knowledge of clinical study documentation. Strong understanding of the industry wide TMF Reference Model.
Strong computer skills (MS Office), SharePoint, and Acrobat or equivalent.
Ability to successfully liaise, work well with people, and establish effective relationships across all levels of the organization and with multiple stakeholders.
Demonstrated ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.
Able to identify improvements in the process to meet the objective and/or recommend alternative tasks that meet objective.
Strong ability to remain focused with regards to details.
Strong organization and time management skills.
Strong client service skills
Strong oral and written communication skills
Strong ability to handle multiple tasks simultaneously; manage and prioritize workload in a proactive manner, and work effectively under the pressure of deadlines.
Demonstrated ability to make decisions involving conflicts of interest.
Ability to format and publish large documents and create and maintain tracking systems and spreadsheets.
Aptitude to learn additional software programs and databases quickly.
Must be able to read, write and speak fluent English
Position Requirements:
Education: BS/BA/BSc degree or its international equivalent. Preferably in Health, Behavioral, Life Science. In lieu of degree, equivalent combination of education, training, and relevant work experience.
Preferred Job-related Experience: A minimum of 3 years of documentation management and experience with FDA, ICH and GCP guidelines Experience with managing clinical study documents using FDA, ICH GCP guidelines and best practices pertaining to clinical trial document management and archiving. Prior experience working in a cross-matrix environment. Experience with an electronic TMF system.
Additional Eligibility Qualifications: Technology to be used: Personal Computer, e-mail, telephone, printer, calculator, copier, cell phones, and other handheld devices. Strong computer skills (MS Office), SharePoint, and Acrobat or equivalent. Ability to format and publish large documents and create and maintain tracking systems and spreadsheets. Ability to coordinate, review, and finalize TMF documentation with multiple stakeholders
Physical Expectations:
Typical office environment.
Ability to sit or stand for extended periods of time.
Ability to move 5 - 15 lbs.
Travel Requirements:
Expected travel time is less than 10% for this position.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.
FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.
This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.
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