The Project Specialist performs administrative and supportive activities assigned by the Manager, IMS, or designee to ensure the contracted services and expectations are met by the IMS team in accordance with executed contracts and customer expectations.
Job Responsibilities
Review Clinical Trial Agreements (CTAs) and amendments to ensure payments are approved per documented costs. Escalate discrepancies as needed.
Attend, prepare, and distribute meeting minutes and action items for both internal and external meetings (e.g., sponsor, functional, investigator meetings).
Follow up on action items to ensure closure.
Collaborate with clinical operations, project management, accounts payable, accounts receivable, and site contracts teams.
Maintain effective communication among team members and site staff, keeping IMS Leadership and Clinical Research Associates (CRAs) updated on site and study status.
Contact site staff as needed for critical information.
Archive all study documents according to appropriate guidelines and policies.
Support quality assurance activities, including preparation for audits and internal reviews, and follow through on actionable issues.
Work with sponsor systems and applications as required by the project.
Qualifications
A degree in Life Sciences, Medicine, Pharmacy, Nursing, or a related field, or an equivalent combination of education and experience.
Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
Strong organizational skills with the ability to manage time and work independently.
High proficiency in MS Office applications.
Excellent communication, presentation, and interpersonal skills, with the ability to inform, influence, and persuade.