Job Code: CNCD02
Position: Clinical Research Associate (CRA)
Department: Clinical Operations
Reports to: Associate Director, Clinical Operation
Location Job Code: Taicang Office/ Remote, China
Provides Clinical Operations team members with project-specific support related to the conduct of clinical trials. Adheres to CONNECT’s policies, Standard Operating Procedures, and Good Clinical Practice ICH Guidelines and ensures projects are conducted within defined budgets and timelines.
- Oversee performance of CRO and vendors by conducting sponsor quality oversight visits, monitoring, and co-monitoring visits to clinical sites in accordance with ICH-GCP guidelines, local regulations, and internal SOPs.
- Oversee monitoring performance by reviewing monitoring visit reports and monitoring metrics.
- Manage clinical site performance by facilitating clinical site audits and/or inspections and by tracking recruitment progress and clinical data quality.
- Evaluate the quality and integrity of site practices and escalate issues with internal team.
- Review study-level and site-level documents, such as clinical study protocol, informed consent forms, monitoring plan, recruitment plan clinical trial site agreements and regulatory documents.
- Assist with investigator/site identification and selection.
- Assist with tracking and management of clinical data, data queries, and clinical data flow.
- Facilitate team meetings and communication between internal and external study team members.
- Attend disease indication project-specific training and general job-related trainings.
Key Performance Indicators:
- Flexibility in adapting/reacting to changing company priorities and competitive or operational challenges.
- Excellent planning and organizational skills.
- Excellent attention to detail and the ability to keep detailed, accurate records.
- Ability to interface with global clinical development teams and foster a collaborative and mutually supportive culture.
- Initiative and leadership to interact with vendors and clinical site staff.
- High sense of urgency and commitment to excellence in the successful achievement of objectives.
- Ability to perform in a fast-paced environment and willingness to take on additional challenges, to stretch beyond, and learn new skills.
- Minimum of a BA/BS degree or equivalent
- 5+ years of clinical research experience
Skills and Attributes:
- Advanced organizational and planning skills
- Proficiency in MS Office Suite
- Strong written and verbal communication skills
- Fluent in English and solid writing skills
Expected Travel Time:
- Up to 20% (but this will be curtailed until travel patterns normalize after COVID-19 pandemic)