Urgent requirement for one of the our top client located in “Cambridge, MA”.
Please contact me at your earliest convenience, along with job No. COM_51607 to xxxxxx.xxxxxx@xxxxxxxxx.xxx
Responsibilities:
Assists in defining protocol(s) and develops informed consent forms, patient instruction guides, and reviews draft case report forms. Serves as a liaison between company and contract research organizations, core laboratories, field sites, investigators, study coordinators, physicians and staff members for specific project or study, as required by the Managers role in trial. Responsible for adhering to and managing clinical trials budget, to include; addressing variances, financial payments, and monitoring the budget throughout the study life cycle. Maintains accurate reporting and provides timely revisions to the budget, upon request. Responsible for meeting timelines and execution of the clinical studies making sure that deliverables, milestones, and budget parameters are met. Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary. Responsible for supporting contracting efforts with investigational sites, contract research organizations (CROs), clinical laboratories, research consultants and other vendors and external suppliers providing research-related services. Prepares requests for proposals (RFP), submits to vendors and reviews bids
Assists others in developing/identifying trial goals, objectives milestones and develops and distributes project status on process, challenges and opportunities on a regular basis. Establishes study milestones and ensures accurate tracking and reporting of study metrics and coordinates Investigator meetings, as required. Assists in the review of draft analysis outputs (tables, listings, graphs) to be incorporated into the final study reports and regulatory submissions. Provides guidance, mentoring, and support to Contract Clinical Research Associates and less experienced Clinical Operations staff members in: auditing central files, collecting/tracking and summarizing patient information and occasional monitoring, as required.
Requirements
Bachelors degree, RN, BSN, or equivalent with a minimum of 5+ years experience in a pharmaceutical/biotechnology, or CRO organization. At least 2 years experience leading trials.
Knowledge of ICH, GCP, and FDA regulatory requirements.
Preferred candidates will have experience in clinical trials of infectious diseases therapeutics, ideally including antivirals.
Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must) to *** xxxxxx.xxxxxx@xxxxxxxxx.xxx ***
Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.
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