Clinical Trial Assistant opening with a Biotech Company!
· Develop TMF Plan, conduct ongoing and final QC checks of TMF for sections owned by CPM; providing CRO or Partner with queries/feedback to ensure correctness and completeness of documents and of TMF overall.
· Provide support for setting-up studies in Clinical Trial Management System (CTMS), provide information to CTMS team to ensure data fields owned by company are kept up to date. Conduct ongoing and final QC checks of the CTMS, liaise with Partners/CPM to provide feedback and ensure resolution of issues.
· Liaise between Partners, CPM, Study Physician, and Legal on local Informed Consent questions and ensure fast resolution.
· Check company Data Standard COA Repository and liaise with CPM to identify vendors and obtain licensing agreements.
· Request the set-up of study mailboxes for all studies and ensure access management.
· Request and review the aggregate financial reports for studies managed by CPM from company Compliance and highlight any significant payments
· Perform spot checks on Site Regulatory Packages (SRP), Form FDA 1572s and PI CVs as necessary.
· Participate in Clinical Study Team meetings and/or other trial-related meetings when their specific expertise is required.
· Contribute to process improvement initiatives and share best practice experience with Line Manager and/or CPM as appropriate.
Experience/Education:
Bachelor's Degree or equivalent work experience in a clinical development work environment required.
2 or more years of experience required, preferably in a clinical development environment, including experience with trial start-up activities and trial documentation
Specific Skills/Competencies:
· Highly proficient in MS Office Suite
· Ability to learn new tasks and skills
· Strong organizational and time management skills
· Preferred scientific and technical skills
· Knowledge of GCP and ICH Guidelines, FDA and/or EU regulations
· Positive attitude towards Change Management
· Basic knowledge of medical terminology