Senior Clinical Research Associate - In House
The Senior Clinical Research Associate will support clinical trial management with the implementation and conduct of clinical trials, focusing on the areas of trial planning, enrollment, site monitoring, data quality, and study reporting. This is a great opportunity at a growing company with many trials planned for 2018.
• Supports the Clinical Trial Manager to provide management and monitoring leadership to assigned clinical trial(s) and ensures protocol requirements, regulatory guidelines and study timelines are met.
• Supports the management of monitoring activities at clinical trial sites to assure adherence to Good Clinical Practices (GCPs) and study protocols.
• Participates in development of department processes and best practices including the evaluation/development/refinement of departmental Standard Operating Procedures (SOPs) and guidelines, and the development of standard reports, templates, and forms.
• Provides guidance with the development of the trial’s protocol, Informed Consent Form, CRFs, monitoring plan, site reference materials, and other study related materials.
• Participates in the assessment and selection of vendors and the management of their ongoing performance, i.e. tracking of contracted costs and milestones.
• Conducts pre-study, study initiation, interim monitoring, and close out visits and completes associated monitoring visit reports and follow up letters to investigators.
• Assists with inspection-readiness activities for regulatory agencies.
• Assists in the planning of and participates in investigator meetings.
• May assist with the development and negotiation of site budgets.
• May mentor less senior CRAs and other members of the Clinical Operations team.
• 3-5 years of industry experience with a CRO / Pharmaceutical or Biotechnology company.
• Management, review and submission of Trial Master File (TMF) documents.
• Expertise with all study related regulatory documents.
• Excellent communication both written and verbal.
• In-depth knowledge of ICH-GCP guidelines, and applicable regulations, rules and guidance, as applicable.
• Keeps abreast of regulatory requirements and scientific knowledge and maintains technical expertise by reading relevant publications, attending courses and through membership in relevant industry/professional associations.
• Bachelor’s degree in a life science or related field of study or equivalent combination of clinical work experience.