The Center for Biostatistics in AIDS Research (CBAR), an organization within the Harvard T.H. Chan School of Public Health, is responsible for the design, monitoring, and statistical analysis of clinical trials and observational studies for several major national and international NIH-funded clinical research networks. CBAR's 70+ statisticians and epidemiologists - which includes Harvard faculty, research scientists, and staff- have provided statistical leadership and support for clinical research networks for more than twenty five years. Currently, these networks include the following: the Adult AIDS Clinical Trials Groups (ACTG), the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT), the Pediatric HIV/AIDS Cohort Study (PHACS), and the Influenza Research Collaboration (IRC). Results from studies CBAR has worked on have helped to establish the paradigm for the treatment and prevention of HIV and other infectious diseases, and have contributed to international treatment and prevention guidelines.
CBAR provides a strong program for growth and professional development for its staff, including opportunities for continuing education and attendance to professional meetings. Competitive benefits are offered as well, such as the opportunity to enroll in courses at Harvard University, tuition assistance, internal and external SAS training, and a generous time off program.
CBAR is seeking an innovative, results-oriented Document and Quality Control Specialist to join the Quality Management team. This group is focused on engineering solutions and supporting CBAR's network–wide research needs. The Document and Quality Control Specialist is responsible for proactively supporting the quality control aspects of Clinical Trial Essential Documents and Trial Master File (TMF) management for CBAR's statistical work on clinical trials and associated studies. This dynamic role collaborates with members of Quality Management to develop and improve upon technical documentation to further support the work performed by our research staff members (statisticians, epidemiologists, and statistical programmers) for the IMPAACT network. IMPAACT is a large NIH-funded collaborative clinical trials network with an international research agenda focused on the treatment, cure, and prevention of HIV infection and associated co-morbidities, particularly tuberculosis and viruses other than HIV, in children, adolescents, and pregnant or breastfeeding women.
Duties and responsibilities include, but are not limited to the following:
Supporting and training research staff members in understanding their Essential Documents and TMF-related responsibilities, requirements, and expectations to ensure compliance with government regulations and Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines
Facilitating regulatory compliance by acting as the point person for Essential Document and TMF questions to manage initiation and close-out of relevant issues. Specifically:
Working with research staff and Quality Management members to define quality control plans and maintain adequate files and documentation
Maintaining awareness of study events and associated documentation requirements through collaboration with research staff members
Proactively conducting periodic assessments of required documents for study protocols throughout a study's lifecycle
Notifying research staff members of any regulatory compliance issues with regard to reporting or maintaining proper regulatory documentation
Duties and Responsibilities will be continued in the "Additional Information" section.
PLEASE NOTE: This position has a term end date of November 30, 2020, with strong possibility for renewal.
Duties and Responsibilities continued:
Contributing to the development and implementation of guidance materials, standard operating procedures (SOPs), and other relevant documents with the Quality Assurance Manager (QAM) and Director of Biostatistics and Programming (DBP)
Supporting research staff members in Essential Documents retrieval during audits and regulatory inspections
Collaborating with Quality Management members to track metrics and corrective and/or preventive actions to satisfactory resolution
Reading, analyzing and interpreting technical procedures or governmental regulations to enhance quality management systems
Participating in research staff meetings and presenting regular updates
PLEASE NOTE: This position has a term end date of November 30, 2020, with strong possibility for renewal. ________________________________________________________________________________________________________
The Harvard T.H. Chan of Public Health is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment – including fostering respect for all, serving the greater good, and welcoming individuals from diverse backgrounds, experiences, and perspectives. To learn more about the Chan School's mission, objectives, and core values, please visit our website here.
Harvard offers an outstanding benefits package including:
Time Off: 3- 4 weeks paid vacation, paid holiday break, 12 paid sick days, 11.5 paid holidays, and 3 paid personal days per year. Medical/Dental/Vision: We offer a variety of excellent medical plans, dental & vision plans, all coverage begins as of your start date. Retirement: University-funded retirement plan with full vesting after 3 years of service. Tuition Assistance Program: Competitive tuition assistance program, $40 per class at the Harvard Extension School and discounted options through participating Harvard grad schools. Transportation: Harvard offers a 50% discounted MBTA pass as well as additional options to assist employees in their daily commute. Wellness Options: Harvard offers programs and classes at little or no cost, including stress management, massages, nutrition, meditation and complimentary health services. Harvard access to athletic facilities, libraries, campus events and many discounts throughout metro Boston.
Join the Harvard T.H. Chan School of Public Health to support our mission of health research and education, and to be a part of the oldest institution of higher learning in the country!
Salary Grade: 054
Union: 55 - Hvd Union Cler & Tech Workers
3+ years of related experience; a combination of experience and education may be considered
Bachelor's degree, in a quantitative or scientific field, strongly preferred
Relevant experience in a clinical trial quality management environment preferred
Knowledge of Good Clinical Practice and International Conference on Harmonisation (ICH) a major plus
High level of self-motivation preferred
Strong attention to detail preferred
Excellent written and oral communication skills preferred
Strong deductive reasoning and organizational skills preferred
Knowledge of Database software and Microsoft Office preferred
Experience producing high-quality documentation, such as reports and templates, appropriate for its intended audience preferred
Experience effectively presenting information and responding to questions from managers, research staff, and network collaborators preferred
Knowledge of statistical and/or clinical trials preferred
EQUAL OPPORTUNITY EMPLOYER: We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Internal Number: 48317BR
About Harvard University T.H. Chan School of Public Health
Harvard University is devoted to excellence in teaching, learning, and research, and to developing leaders in many disciplines who make a difference globally. The University, which is based in Cambridge and Boston, Massachusetts, has an enrollment of over 20,000 degree candidates, including undergraduate, graduate, and professional students. Harvard has more than 360,000 alumni around the world. The University has twelve degree-granting Schools in addition to the Radcliffe Institute for Advanced Study, offering a truly global education. Established in 1636, Harvard is the oldest institution of higher education in the United States.