Site Specialist

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.