Supports Project Manager to ensure the contracted services and expectations of a clinical study are carried out by the INC Research (INCR) project team in accordance with the executed contract and the Customer’s expectations. Tracks and analyzes project details and maintains internal systems for assigned projects within a therapeutic area. Ensures adherence to Good Clinical Practices, regulatory guidelines, and study procedures on assigned projects. Mentors and coaches Site Activation Specialists/Senior Site Activation Specialists in specialized areas of expertise (e.g. ICF/IB/IRB/Advertising review teams).
Core Responsibilities: 1. Utilizes designated clinical trial management system to track and process clinical trial information, (e.g., regulatory documents, enrollment, SAE/ AEs, protocol deviations, supplies, IRB re-approvals, data queries) in order to provide analysis of information to Project Leader (PL).
2. Updates Project Leadership and CRAs of sites and study status. Prepares and presents analysis of project level details such as enrollment, regulatory document collection, and data collection/review. Contacts site staff for critical information.
3 Oversees regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) 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.
4. Assists the PL 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.
5. Processes and tracks vendor invoices, site invoices, and investigator grants payments on assigned projects. Supports assigned Project Leader (PL) with initiating requests to INCR Finance Department to generate customer invoices for project labor and expenses.
6. Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PL. Assesses and communicates KPIs for associated job tasks to PL with proposed action plan.
7. Serves as primary customer contact when PL is out of the office. Seeks input from Project Director for customer support.
8. Prepares and provides status reports to customers with oversight from assigned PL.
9. Schedules and attends internal and external team meetings. May lead internal team meetings and portions of external team meetings, as directed by assigned PL. 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.
10. Prepares for and attends investigator’s meetings. Participates in Kick-Off Meeting, Quick Start Camp,and Quality Finish Camps.
11. Assists in the development of informed consent form (ICF) using project specific knowledge and performs in-house Case Report Form (CRF) review.
12. Serves as administrator of shared workspace for assigned projects.
Skills & Attributes: Requires a B.A. /B.S., in the science/healthcare field, nursing degree, plus nominal clinical research experience, or equivalent combination of education and experience. Some experience in an INCR therapeutic group preferred, with demonstrated leadership skills and effective customer interaction. Requires exceptional attention to detail, organizational, interpersonal, and communication skills with demonstration of critical thinking and problem solving skills. The ability to perform several tasks simultaneously to meet deadlines is necessary. Self-motivation and ability to work independently are required. Ability to assist in establishing and maintaining standards, system integrity, and ensuring quality assurance measurements is required. Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), MS Project, web-based systems, email, and voicemail are required.
For employees in the United States ONLY
FLSA status: ______Exempt___________________________________________
Years of experience required: ___Two (2) years____________________________
Skills & Attributes
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.
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