The Project Specialist performs administrative and supportive activities assigned by the Project Lead to ensure the contracted services and expectations are carried out by the project team in accordance with executed contracts and the customers' expectations.
Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.
Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.
Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information.
Provide administrative support to Project Leads and functional leads.
Ensure all study documents are archived based on the appropriate guidelines and policy.
Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.
Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience
Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
Strong organizational skills.
Ability to manage time and work independently.
High proficiency with full MS Office Applications.
Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Ability to travel if necessary preferred (approximately 5%)
High level of competence in English language
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.
INC Research Inc