Job Board
Program Research Coordinator/ Program Associate
Date Posted: 9/27/2011
Organization: Gynuity Health Projects
Location: New York, NY
Salary: Commensurate with experience and training; excellent benefits
Description of Organization:
Gynuity Health Projects is a research and technical assistance organization dedicated to the idea that
all people should have access to the fruits of medical science and reproductive technology
development. We focus primarily on resource-poor environments, underserved populations, and
challenging subjects. To this end, Gynuity works globally to ensure that reproductive health
technologies are widely available, provided in the context of high-quality services, and offered in a
way that recognizes the dignity and autonomy of each individual. We conduct clinical, service
delivery, and social science research on a range of reproductive health technologies. We also provide
technical assistance on ways to improve services and service-delivery options.
Position Responsibilities:
Help to plan and organize a clinical trial to assess the efficacy and safety of an investigational hormonal
contraceptive method. The trial will be intended to produce pivotal data for a new drug application to the
USFDA or other stringent regulatory authority. The trial will include several thousand women at
numerous sites in multiple countries. This position is currently funded full time for 1 year; extension of
employment will be contingent on additional funding.
- Identify potential new study sites in the US and in other countries worldwide by networking, internet
searches, literature reviews, or other means.
- Collaborate in planning a process for evaluating the suitability of these sites to participate in the
proposed clinical trial and the approval process and timeline needed to initiate the trial. This process
may include: soliciting documents or other information from the sites, conducting surveys of the
patient population served by the sites; visiting the site.
- Oversee and participate in conducting the implementation of the site evaluation plan.
- Design and manage any site population surveys, including data management, and analyze and
interpret the survey results.
- Negotiate draft budgets with sites that are found to be good candidates.
- Collaborate in the production of documents required to implement the trial, including a study
protocol, instruction manual, monitoring plan, data management plan, and analysis plan.
- Prepare and give presentations at meetings related to the project, including meetings of the project’s
Technical Advisory Group.
- Collaborate closely with the project team, which is composed of individuals at Gynuity and other
organizations.
Qualifications:
- Experience managing regulated clinical trials, that is, trials conducted under an Investigational New
Drug application with the FDA, or the equivalent with another regulatory agency for the purpose of
generating data for use in registering a new drug.
- Experience managing or monitoring clinical trials conducted outside the US.
- Thorough knowledge of Good Clinical Practice regulations as applied to clinical trials of investigational drugs.
- Experience designing, managing, and analyzing simple surveys.
- Experience in negotiating and evaluating clinical trial site budgets.
- Experience training site staff conducting clinical trials.
- Ability to travel within the US and internationally up to 40% of time.
- Interest in reproductive health.
- Facility with Microsoft Word and Excel. Knowledge of Access a plus.
- Strong organizational skills. Ability to juggle many tasks, and prioritize accordingly.
- Excellent communication skills in writing and orally.
- Ability to work and travel independently.
- Minimum two years’ relevant work experience.
- MPH or other postgraduate degree in related area.
- Ideally, located in New York, but other locations will be considered.
Apply To:
Submit resume and cover letter with salary requirements to:
- Email: pubinfo@gynuity.org , please refer to “OC project” in “Subject” line of your email
- Fax: 1-212-448-1260, Attn: “OC project”
- Mail: Gynuity Health Projects, Attn: “OC project”, 15 East 26th Street, #801 New York, NY
10010
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