FHI Clinical
FHI 360 staff working in the United States are required to be fully vaccinated for COVID-19, regardless of the type of project or client they serve, or of their employment status (full/part-time, remote, telework, or in-office), unless an accommodation applies. FHI 360 complies with federal, state, and local laws with regard to accommodations related to this policy. Full vaccination is currently defined as two weeks after the second dose in a two-dose series, such as the Pfizer-BioNTech or Moderna vaccine, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine. Booster doses are not required at this time.
Summary of the Position:
The TMF Specialist I 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 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.
- 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 with archival and destruction activities, as needed.
- All other duties as assigned.
Knowledge, Skills and Abilities:
- Must have data entry experience.
- Experience with TMF and strong knowledge of clinical study documentation. General 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.
- Strong ability to remain focused with regard 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, an equivalent combination of education, training, and relevant work experience.
Preferred Job-Related Experience:
- 1-3 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 for 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.
- 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.
FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others and yourself.
About Us
FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing creating a unique mix of capabilities to address today’s interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.
As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.
FHI 360 staff working in the United States are required to be fully vaccinated for COVID-19, regardless of the type of project or client they serve, or of their employment status (full/part-time, remote, telework, or in-office), unless an accommodation applies. FHI 360 complies with federal, state, and local laws with regard to accommodations related to this policy.
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.
FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.