The Clinical Research Associate in collaboration with the Clinical Trial Manager and/or other operational leadership, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of Contract Research Organization (CRO) teams and other vendors.
- Provide operational input on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
- Contribute to deliverables within study, drive to solutions across a multi-functional study team.
- Anticipate and resolve key technical operational problems with multi-functional study team; evaluate and determine issues that require escalation.
- Use performance metrics and quality indicators to assist with driving study execution.
- Manage the monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
- Ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
- Develop and maintain collaborative relationships with internal and external partners/stakeholders including both vendors and investigational sites.
- Collaborate with vendors and other study team members regarding study specific issues and follow through to resolution.
- Assist in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials and assist in updating these study documents as needed. The CRA may have opportunities to lead creation/updates/review of study documents, as agreed upon with assigned Clinical Trial Manager or Clinical Operations leadership.
- Participate in vendor specification development and management/oversight. Vendor oversight activities may include responsibility for specific tasks associated with oversight (ie, review of monitoring visit reports generated by CRO) or may opportunities to lead the overall management of a specific vendor (ie, travel vendor), as agreed upon with assigned Clinical Trial Manager or Clinical Operations leadership.
- Management of TMF set-up, ongoing quality review, and final reconciliation.
- In conjunction with Drug Supply Management, manage shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
- Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required.
- Contribute to data review/cleaning of clinical data as needed and as defined by study plans.
- Actively contribute during study meetings including presenting as a subject matter expert as well as generating and distributing study team agendas and meeting minutes.
- Contribute to development / coordination of study training and study training materials for study team, investigational sites, and vendors.
- Assist with the collection of various study documents such as country/site insurance, CSR appendices, etc.
- Assist with Investigator Meeting coordination and planning.
- BA/BS Degree in a relevant discipline with 2-4 years’ experience in the clinical trial environment required (inclusive of site level or other relevant experience) for Clinical Research Associate level.
- Knowledge of ICH/GCP and regulatory guidelines/directives.
- Demonstrates analytical approach and anticipation of problems.
- Ability to multi-task effectively and prioritize assignments from multiple sources.
- Excellent organizational skills.
- Strong communication skills, both written and oral; proficiency in English.
- Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
- Knowledge of study tools including electronic system skills such as CTMS/ EDC/ IRT/ eTMF.
- Knowledge of drug development process. Proactively shares information, ideas, input, and/or expertise with team members. Demonstrates concern for high quality outcomes.
- Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
- Ability to travel domestic and international as needed