Description:
· Supporting the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved.
· Support sites and study teams to achieve rapid site start up.
ACCOUNTABILITIES:
· Work directly with assigned sites on all site related essential document collection and review.
· Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes.
· Ensure standards are applied to the SSU processes across projects.
· Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc
· Promptly recognize and improve potential site activation delays and escalate to appropriate team members.
· Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
· Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
· Review and provide feedback to management on site performance metrics.
· Ensure accuracy and completeness of the eTMF for assigned sites during start up
EDUCATION/COMPENTENCIES/SKILLS:
· BS degree or international equivalent
· 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
· Ability to explain data to facilitate decision making processes to be data driven.
· Knowledge and understanding of clinical study protocols and essential documents
· Strong organizational skills, decision making, communication and negotiation skills
· Proficient in Microsoft Excel, Word, and PowerPoint.
Organization | Eliassen Group |
Industry | Management Jobs |
Occupational Category | Site Specialist |
Job Location | London,UK |
Shift Type | Morning |
Job Type | Full Time |
Gender | No Preference |
Career Level | Intermediate |
Experience | 2 Years |
Posted at | 2024-07-17 7:07 pm |
Expires on | 2025-01-22 |