Senior Clinical Research Associate

About the role

The Senior Clinical Research Associate (CRA) at uniQure is responsible for overseeing all clinical sites facing activities, from feasibility to site closure. They will support the clinical sites in executing protocols, ensuring compliance, and providing training and guidance.

Responsibilities

• Supports oversight of all clinical sites facing activities, from feasibility up to site closure
• Performs remote or on-site monitoring visits to ensure compliance with the protocol, ICH/ GCP, validity and accuracy of data collected
• Co-monitors visits with CROs CRAs, reviews their monitoring visit reports and follow-up letters
• Reviews and analyzes sites’ performance including protocol deviations and recommends corrective and preventative actions
• Supports and directs sites with data entry and queries resolution to ensure proper data flow and ability to identify safety events
• Supports sites with patient’s enrollment tactics and guides them through the eligibility determination process
• Provides ongoing training to sites staff around the study protocol and amendments as well as relevant study level manuals
• Ensures proper ongoing filing in the investigator site file by the site staff
• Supports sites level start up activities to facilitate IRBs/ECs submissions and approvals as well as site contracts
• Supports the development of study plans/documents and tools, such as recruitment and monitoring plans, ICF templates, site binder contents, etc
• Aids in audit/inspection readiness activities, including mock audits, support on-site audits, storyboard generation, documentation of corrective action plans
• May 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

Requirements

• Bachelor’s degree in life sciences required; science/medical related degree preferred
• 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
• 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

Qualifications & Skills

• 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
• 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

Pay

The estimated salary range for this position is $116,000 - $150,000. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant, relevant years of experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from where they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.