PPD DEVELOPMENT L.P.
929 N Frost St.
Wilmington, North Carolina
28401-3331, United States
Background/Description of Requirement
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 as needed to perform the Statement of Work below:
• Provide assistance for a for-cause site visit and draft a report of the visit
Assist NIMH staff on site to provide for-cause specific visit activities that may involve, but not limited to the review of subject level data, protocol adherence, adverse event reporting, staff training, etc. At the end of the site visit, write a draft report of the for-cause site visit.
Government Furnished Information (GFI):
Government Furnished Information, including study data, shall be provided for the purposes of executing this requirement. Consultant(s) shall guarantee strict confidentiality of the information/data that it is provided by the NIH or by any other participant on the project to which the contractor is assigned.
The Contractor shall propose one (1) Principal Clinical Research Associate as key personnel for this contract. The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:
The key personnel specified in this contract are considered to be essential to work performance. At least 10 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty day notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.
Principal Clinical Research Associate Role Description:
The Principal Clinical Research Associate shall review for-cause visit documents, protocols, and other study related documents to assist and provide selected training for NIMH staff on site and provide support for any for-cause visit activities.
Principal Clinical Research Associate Mandatory Qualifications:
The Principal Clinical Research Associate must have a master’s degree or equivalent experience in a relevant scientific discipline and extensive experience (approximately 10 or more years) in clinical monitoring activities.
Principal Clinical Research Associate up to 100 hours total for preparation for and assistance in the for-cause site visit activities that includes being on site for the for-cause visit.
DELIVERY OR DELIVERABLES
The Contractor shall provide the following deliverables, status update meetings, and reports:
On site for-cause site visit
Participate during the full week for-cause site visit and provide assistance and guidance to NIMH staff and participate in preparation of site visit related activities and provide guidance during the visit. Develop a draft written report of the visit within 5 business days of the end of the site visit.