Research Study Manager

Updated: 2 months ago
Location: Boston, MASSACHUSETTS

01-May-2020

Harvard Medical School

52129BR


Job Code

RS0057 Researcher III Humanities


Job-Specific Responsibilities

endTB (Expand New Drugs for TB) is a multi-year project funded by UNITAID, led by Partners In Health, and with consortium partners Medecins sans Frontieres (MSF) and Interactive Research & Development (IRD).The research component of endTB includes a multi-center prospective observational study on the safety and efficacy of multidrug-resistant tuberculosis (MDR-TB) treated with multidrug regimens containing bedaquiline or delamanid and two international multicentre randomized therapeutic trials to evaluate short, oral drug regimens for the treatment of multidrug resistant tuberculosis. The trials are a collaborative project among PIH, DGHSM, MSF, the Institute of Tropical Medicine (ITM, Antwerp, Belgium) and Epicentre (Paris, France), and the Interactive Research and Development (Pakistan). The research manager will work primarily on the trials and substudies and may also support the observational study.
The DGHSM is seeking an interim endTB research manager to manage clinical study activities across PIH sites, including clinical operations, pharmacy and laboratory activities, finance, data management, quality assurance, regulations, and logistics; serving as primary communication node among research sites, central team, and operational teams within partner institutions; developing and adhering to milestones; includes systems analysis and continuing improvement, documentation, and cross-site learning.

  • Manage amendment and ethics and regulatory approvals of amended study protocol(s) and associated study documents at the central level and at PIH sites, with strict version control; coordinate changes with MSF and IRD counterparts.
  • Synthesize findings from site data and procedure monitoring to implement corrective actions and advise central team as necessary.
  • In conjunction with central trial operations team and HMS PV Officer/Peru focal point, coordinate and standardize study activities, operations and training across sites; oversee multi-center research aspects to prepare for internal and external audits, monitoring, regulatory/site visits, and inspections.
  • Perform documentation related to these activities.
  • Coach and motivate site coordination teams, facilitating the team(s)’ ability to fulfill their responsibilities in accordance with the study protocols; organize (and provide, where appropriate) site (re)training in ICH-GCP and study specifics.
  • Manage updating of site-specific study documents, procedures that are consistent with the protocols, ICH-GCP, and human-subjects research protection.
  • Ensure appropriate maintenance and storage of site investigator files and all study documents, at central and site levels.
  • Support site teams in development/updating of all study procedures (administrative, clinical, lab, logistical).
  • Support site and central staff in personnel decisions and professional development.
  • Conduct site assessment, initiation and close-out visits on behalf of the trial manager if required.
  • Travel to PIH sites for research meetings, study planning, and training of site staff in study processes, including electronic data entry, quality control, and quality assurance on behalf of data manager.
  • Contribute to production of reports (to funder and for research purposes) and dissemination of research.
  • Supervise endTB Research Assistant.

Basic Qualifications

Bachelor's degree in health sciences or related field; at least 5 years of relevant clinical research experience, management experience; thorough knowledge of ICH-GCP guidelines; experience in low-resource settings outside US. Must be able to travel overseas.


Additional Qualifications

MPH or related degree preferred. Strong interest in social justice, healthcare, and global health. Excellent written, verbal communication; time management and organization; ability to prioritize and coordinate multiple tasks in timely manner.


Additional Information

This is a term appointment with the end date of 10/30/2020 with the possibility of renewal.

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 complementary health services.
Harvard access to athletic facilities, libraries, campus events and many discounts throughout metro Boston.
The Harvard Medical School is not able to provide visa sponsorship for this position.


Location

USA - MA - Boston


Department

Global Health and Social Medicine


Union

00 - Non Union, Exempt or Temporary


Appointment End Date

30-Oct-2020


Pre-Employment Screening

Education, Identity


Schedule

​35 hrs. per week | Monday - Friday | 9:00 am - 5:00 pm


EEO Statement

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, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law.


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