Clinical Trial Assistant
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
Clinical Trial Assistant
Clinical Trial Assistant opening with a Biotech Company!. 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. Participate in Clinical Study Team meetings and/or other trial-rel...
Administrative Assistant - Earn $22/hr-$38/hr, Full-Time/Part-Time, Flexible, Remote/On-Site
...
Manager, Clinical Trials Operations, Dcri
Manage and direct the efforts of a designated group of project leaders in order to ensure effective planning, oversight and coordination of clinical research projects. Ensure appropriate involvement and input of project leaders in the development and negotiation of trial budgets and contracts. Monit...
Administrative Assistant- Part Time
We are looking for an experienced Administrative Assistant/Office Manager to join our team! The Administrative Assistant/Office Manager will be responsible for overall office management of our corporate office in Charlottesville, VA, as well as operations support across the company. Administrative A...
Clinical Research Coordinator Nurse (RN)
Clinical Research Coordinator Nurse. Attending investigator meetings, site initiation visits, and coordinator meetings to obtain training on drug preparation and administration and general knowledge about a protocol with a focus on clinical procedures. Performing technical and clinical requirements ...
Administrative Assistant/Office Coordinator
The Administrative Assistant will perform administrative duties for the Raleigh Branch Manager. Administrative Assistant/Office Coordinator. The Administrative Assistant’s main duties include answering phones, greeting visitors, scheduling meetings, maintaining sales bid calendar, making trave...
Financial Analyst/Financial Project Coordinator
Job Title: Sr Financial Analyst.Location: Raleigh, NC– Hybrid (3 days onsite per week).Reclass entry preparation, standard and Intercompany.Post-Close Financial Analysis/Reporting.Prepare and present Financial Package to Leadership.Filter EE Infra Svcs Purchase Order setups through 1-2 people.Cut do...
Project Architect/Project Manager
PROJECT ARCHITECT/PROJECT MANAGER. National Architecture & Engineering firm is looking for a talented Project Architect/Project Manager to join their growing Raleigh studio. Check in with Project Managers at each project milestone to ensure design quality control/assurance . Keywords &nda...
Project Manager 1 - FFEx - Aseptic Production
The Project Manager will ensure strict adherence to timelines, budget constraints, and project scope. The Project Manager will oversee the expansion and optimization of the Aseptic Production line, focusing specifically on high-speed, automated filling and aseptic processing technologies. Coached by...
ServiceNow Implementation Project Manager - Cary, NC
Our enterprise-level client is seeking to add a ServiceNow Implementation Project Manager to work onsite in Cary, NC. We are looking for a Project Manager / Product Owner, who has experience implementing ServiceNow (not user level experience). Manage Service Delivery for Quote/Proposal Management Ap...