Clinical Trial Specialist

BS/BA in Scientific field or equivalent and 2+ years of clinical trials or operations experience, CRO/Vendor Management exposure is preferred. Participation in monitoring clinical trials or related experience preferred OR
Master’s degree in Scientific field or equivalent and some experience as noted above
Working knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive
Working knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out.
Some trial management protocol and process knowledge
General understanding of Clinical Research industry and the relevant environments in which it operates
Ability to plan activities and works well under changing circumstances; manages time effectively
Has some knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
Works to improve tools and processes within functional area
Ability to work as part of a team
Strong computer skills
Good communications, problem-solving, analytical thinking skills
Sees impact on department
Ability to meet multiple deadlines across a project/program, with a high degree of accuracy and efficiency
Developing project management skills
Ability at analyzing data and information to derive options/recommendations for management considerations

Work alongside Clinical Trial Managers to ensure compliance with regulatory guidelines and company SOPs
Serve as a key team member for assigned clinical studies
Provide administrative support by handling invoices, tracking metrics, and managing issues with contract service providers
Participate in study team meetings, tracking study issues, and assisting with recruitment efforts
Collaborate within clinical operations to document standard processes across clinical programs
Develop relationships with investigator sites, IRBs/IECs, and CROs to meet trial requirements
Coordinate essential document collection and IRB/IEC submissions, ensuring compliance throughout trials
Facilitate study start-up processes and resolving quality issues with documents
Support study monitors with document updates and addressing related questions
Ensure eTMF documents are organized according to SOPs, policies, and standards
Perform eTMF QC or Inspection Readiness QC and documenting findings for resolution
Additional duties as assigned to contribute to the success of clinical trials