The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Institute of Child Health and Human Development (NICHD) has a continuing requirement for Statistical and Clinical Coordinating.

The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead Federal agency for the conduct of basic, clinical, and epidemiologic research to develop new and evaluate existing methods of contraceptives and reproductive health. The Center of Population Research (CPR), within NICHD, was established in 1968 by the Secretary of Health Education and Welfare, (formally Department of Health, Education and Welfare), with the important goal of developing new contraceptives using contracts and grants. Under the CPR mission, the Contraceptive Development Branch (CDB) supported preclinical contraceptive testing facilities as well as facilities for chemical and peptide synthesis. To further expand their contraceptive development capabilities, in 1996, CDB established the NICHD Contraceptive Clinical Trials Network (CCTN) consisting of a Statistical and Clinical Coordinating Center (SCCC) and 8 highly qualified sites to evaluate new contraceptive methods for women. The initial CCTN did not have any sites dedicated to male contraception. In 2004, the network was expanded through a competitive RFP, and sites for male contraceptive development were added. In 2013, the CCTN was again recompeted and expanded to 19 sites for female contraceptive evaluation and 2 sites for male contraception. In 2017, the NICHD established the Contraceptive Development Program (CDP) as a component of the Division of Intramural Population Health Research (DIPHR), with the mission to develop and evaluate new methods of contraception for women and men through the CCTN. As of 2018, the CCTN has completed 24 clinical trials including Phase I, II and III trials on novel female contraceptive methods and Phase I and II trials on male contraceptive methods. In addition, there are two actively enrolling clinical trials as well as one new Phase III trial that will begin enrollment in 2023. All clinical trials are coordinated and monitored by the SCCC under the technical direction of the Program Manager (Chief, CDP), the Contracting Officer’s Representative (COR) and the Medical Officer (MO).

• Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government under the terms of this contract as needed to provide statistical and clinical coordination and conduct of contraceptive clinical trials. Trials may involve male or female contraceptive drugs or devices in Phase I, II, III or IV of clinical evaluation
• Participate in study design of concept plans and protocols in collaboration with the CDP Chief, CDP COR, CDP MO, and the Principal Investigators of the CCTN sites. Provide draft protocol and draft protocol amendments for each study. Develop draft informed consent documents that are consistent with government regulations. Coordinate site submissions to comply with submission to a single IRB for multi-site clinical trials
• Design data collection instruments and coordinate all data management and data analysis aspects of the trials. Ensure FISMA compliance (21 CFR Part 11). Demonstrate capability for electronic information systems to be validated and to be either compliant or obtain compliance with the Federal Information Security Modernization Act (FISMA) per 21 CFR Part 11
• Demonstrate capability to provide services for development and review of new and ongoing research activities, including a protocol development team and protocol development plan. Ability to draft and edit protocols? maintain necessary documentation for application submissions in compliance with FDA requirements? provide support for the planning and conduct of meetings of protocol committees and subcommittees, data and safety monitoring boards, and investigators? administrative, technical, and logistical support for research activities
• Monitor, coordinate and conduct contraceptive clinical trials for novel male contraceptive or female contraceptive products. The Contractor shall monitor each clinical trial and shall maintain records in accordance with current FDA regulations and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. The SCCC should ensure that trials are conducted ethically, in accordance with GCP, with attention to human subject safety. The SCCC will conduct monitoring for sites conducting clinical trials to ensure appropriate trial conduct and adherence. Information on current Food and Drug Administration (FDA) regulations applicable to clinical trials and ICH GCP guidelines can be found at the following web sites: ICH GCP: https://ichgcp.net/ FDA: http://www.fda.gov/
• Monitor training of clinical site personnel and quality assurance of data collected in clinical studies
• Coordinate tracking of laboratory specimens as required for specific studies, ensure that all protocol-specified laboratory tests are completed, and that the results are accurately reported as specified in the applicable study protocol
• Prepare Clinical Study Reports of clinical trials in a manner acceptable to FDA and equivalent stringent regulatory agencies for drugs, including initiation and maintenance of IND applications and NDAs; and, for devices, Premarket notifications 510K, PMAs, and IDEs
• Provide, through subcontractors, if necessary, ancillary services to assist in the organization or acquisition of materials and services required to conduct contraceptive clinical trials or provide clinical data. Such services might include drug or device procurement, drug formulation (including encapsulation), drug packaging, distribution, and destruction, facilities for central lab and stability testing, consultants for histology or pathology, medical specialties, etc., as required for a specific study. Where IND holders do not have product liability insurance, the SCCC may be required to assist in the acquisition of such insurance
• Work in close collaboration with the clinical sites, laboratory contractors, the Data and Safety Monitoring Board and the Scientific Advisory Committee (SAC) to assist NICHD in coordinating activities of the network
• Cooperate and collaborate with NICHD external partners via cooperative research and development agreements (CRADA) for the purpose of protocol design, organization, coordination, monitoring, and data analysis of trials evaluating novel methods of contraception for men and women
• All work performed by the SCCC for the CCTN shall be monitored by the CDP COR and NICHD Contracting Officer (CO)
• Only de-identified data shall be collected under all current and future task orders under this contract.