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Post: Project Specialist II (India)
Job Description
Responsibilities
1. Utilizes designated clinical trial management system to track and process clinical trial information, (e.g., regulatory documents, enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, supplies, Institutional Review Board re-approvals, data queries) in order to provide analysis of information to PM. Processes and tracks vendor invoices, site invoices, and investigator grants payments on assigned projects. Supports assigned PM with initiating requests to Finance Department to generate customer invoices for project labor and expenses. Oversees regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. May conduct secondary review of Essential Regulatory Documents. May serve as project representative for internal and external TMF audits. May serve as in-house site contact for collection of non-essential regulatory documents, tracking and maintaining drug/study supplies, query resolution, administrative protocol and study related questions. Assists the PM with projection and validation of financial backlog and project realization on assigned projects. Includes review of regular financial reports and analysis of upcoming project events to verify financial forecasts. Assists in the development of Informed Consent Form using project specific knowledge and performs in-house Case Report Form review.
2. Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PM. Assesses and communicates KPIs for associated job tasks to PM with proposed action plan. Prepares and provides status reports to customers with oversight from assigned PM.
3. Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. Schedules and attends internal and external team meetings. May lead internal team meetings and portions of external team meetings as directed by assigned PM. Prepares and distributes all meetings minutes for both internal and external meetings. Follows-up with team members on action items from meetings. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans. Prepares for and attends Investigator Meetings, Kick-Off Meetings, Quick Start Camps, and Quality Finish Camps.
Candidate Profile
Bachelor Degree in the science/healthcare field, nursing degree, or equivalent combination of education and experience.
Basic understanding and knowledge of ongoing protocol and disease related terminology, FDA regulations, GCP/ICH guidelines, drug development process for assigned study, as well as company and sponsor SOPs and WIs.
Exceptional attention to detail, organizational, interpersonal, and communication skills with demonstration of critical thinking and problem solving skills.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Additional Information:
Education: Bachelors Degree
Location: Gurgaon
Industry Type: Pharma/ Biotech/Clinical Research
Job ID: 15002934
End Date: 25th May, 2015
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