Note: The job is a remote job and is open to candidates in USA. uniQure is delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. The Senior Clinical Research Associate will act as an ambassador for clinical sites, supporting the execution of clinical protocols and ensuring compliance with regulations.
Responsibilities
- Supports oversight of all clinical sites facing activities, from feasibility up to site closure
- Perform remote or on-site monitoring visits to ensure compliance with the protocol, ICH/ GCP, validity and accuracy of data collected
- Perform co-monitoring visits with CROs CRAs, as well as be the main point to review CROs CRAs monitoring visit reports and follow-up letters
- Review and analyze sites’ performance including protocol deviations and recommend corrective and preventative actions
- Support and direct sites with data entry and queries resolution to ensure proper data flow and ability to identify safety events
- Support sites with patient’s enrollment tactics and guide them through the eligibility determination process
- Provide ongoing training to sites staff around the study protocol and amendments as well as relevant study level manuals
- Ensure proper ongoing filing in the investigator site file by the site staff
- Ensure proper supply of IMP, labs kits and other study related supplies and equipment
- Support sites level start up activities to facilitate IRBs/ ECs submissions and approvals as well as site contracts. All within the shortest timelines possible
- Assist in the development of study plans/documents and tools, such as recruitment and monitoring plans, Informed Consent Form (ICF) templates, site binder contents, etc
- Support audit/inspection readiness activities, including mock audits, support on-site audits, storyboard generation, documentation of corrective action plans
- May be asked to assist or perform CTM activities, such as vendors oversight, planning and oversight of the project timelines, budget, and quality including the facilitation of internal and external meetings
Skills
- Bachelor's degree life sciences required
- Minimum of 8 years of related clinical monitoring research experience with at least 3 years of on-site monitoring experience
- Inspection readiness experience, required
- Demonstrates excellent understanding and application of ICH/GCP guidelines, including knowing which guidelines apply to the current study phase and work, understands the implications of not following GCP/ICH guidelines, and is adept at recognizing a breach. Also demonstrates awareness and understanding of interdependencies of other GxP regulations
- Demonstrated communication, and organizational skills, along with problem solving and conflict resolution
- Strong interpersonal and communication skills, able to conduct self in diplomatic manner in challenging situations
- Ability to travel up to 40%
- Enthusiastic and proactive, with a can-do attitude, thrives working in a fast-paced environment and able to manage competing tasks and demands with a sense of urgency
- Science/medical related degree preferred
- Experience in complex clinical research projects and early drug development very desirable, particularly within an orphan/rare disease therapeutic area
Company Overview
Company H1B Sponsorship