Clinical Research Associate (CRA)
Job description
Place in the Organization At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments. The main mission of the Clinical Research Associate (CRA) is to act as uniQure’s clinical sites facing ambassador, building impactful relationships with the sites participating in our clinical programs. The CRA will be supporting the clinical sites in the proper execution of one or more protocols delivery, removing executional barriers, guiding and training the sites as well as ensuring compliance with the protocol and regulations. Key result areas (major duties, accountabilities and 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
- Bachelor’s degree life sciences required; science/medical related degree preferred
- Minimum of 5 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
- Experience in complex clinical research projects and early drug development very desirable, particularly within an orphan/rare disease therapeutic area
- 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