(Senior) Clinical Research Associate
uniQure is dedicated to bringing innovative therapies or unmet medical needs to
patients. In doing so, each function in uniQure is directly or indirectly responsible for
the lives of patients, and this responsibility is incorporated be into our
day-to-day work by living up to high quality standards and by recognizing a sense of urgency in areas of high medical need.
The Clinical Research Associate (CRA) – In-House is a valuable member of the global Clinical Operations Department, acts as uniQure’s clinical site facing ambassador, building impactful and sustainable relationships, supporting the clinical sites in proper delivery, removing executional barriers, all in an effort to position uniQure as the sponsor of choice in the gene therapy space. This position will be a key enabler of clinical sites success in respect to study enrollment, site relationships, data integrity and overall quality. Responsibilities will include a focus on the investigators (+ staff), regulations, compliance, timelines, data collection and review, and safety reporting. The In-house CRA may support a specific region or cross-regions and may be assigned up to 1-2 projects, with flexibility to assume other additional project assignments. This position is an excellent opportunity for career development as uniQure build out the infrastructure to support its clinical pipeline.
Key result areas (major duties, accountabilities and responsibilities)
- Supports oversight of clinical site-facing activities with minimal direction, such as conduct site feasibility and ensure proper site selection and setup, as required, assess ongoing site performance, ensure submission and approval by relevant Institutional Review Board(s), Ethics Committee(s) and other local bodies (except clinical trial application(s)); adequacy of monitoring activities and documentation for assigned protocols, evaluating the quality and integrity of site practices and adherence to ICH/GCPs.
- Alongside other functions in uniQure such as the medical team, demonstrate the ability to act as the company main point of contact for the clinical sites, build impactful and sustainable relationships, supporting the clinical sites in proper delivery, removing executional barriers, all in an effort to position uniQure as the sponsor of choice in the gene therapy space.
- May perform remote or on site, co-monitoring & monitoring oversight activities with the CRO to assure study conduct adheres to ICH GCP, Standard Operating Procedures (SOPs), study protocol and applicable study plan(s) with minimal oversight.
- Review monitoring visit reports and follow-up letters per Clinical Trial Management Plan (CTMP) and escalate monitoring trends or findings (i.e. deviations, deficiencies, etc.) and recommend actions to secure compliance to the Clinical Trial Manager (CTM)/Directors.
- Demonstrate the ability to independently review and analyze site performance and monitoring metrics on a regular basis with CTM/Director to ensure compliance with SOPs and study plans sites (in coordination with the CRO) management activities, such as identification/feasibility, patient status/enrollment, data cleaning support and ensure all sites are properly closed-out. Escalate site issues with proposed corrective and preventative actions to CTM/Director.
- Develop a strong working relationship with sites and provide support as needed to sites (in coordination with the CRO) to facilitate site identification/feasibility, site management activities, such as patient status/enrollment tracking, and data cleaning support. May be tasked to conduct site feasibility and identification and start up activities.
- As circumstances require, demonstrate the ability to independently contact study sites for specific requests (e.g. recruitment updates, missing documentation, action item resolution status) or issues related to study conduct and other sponsor-specific in-house CRA tasks.
- Interact with sites, CRO and other vendors as applicable addressing site-specific facing activities, as well as the internal study team members and participate in internal meetings and external meetings, as required.
- Demonstrate the ability to provide quality support to the internal Data Manager in remote clinical data review, identify trends, aging queries and delayed EDC data entry. Work in conjunction with the internal Data Manager and the Clinical Research Organization (CRO) to resolve these issues
- Provides clinical supply projections and approves clinical supply demand
- Demonstrate the ability to provide guidance and mentoring to project team members
- Communicates the closure of clinical trial sites to relevant internal and external stakeholders and closes all site-related systems and tools used in the clinical trial
- Ensures all sites are properly closed-out by the CRAs.
- Demonstrates the ability to focus on operational efficiency and identifies and communicates inefficiencies with proposed solutions; Assist in the development of study plans/documents and tools, such as recruitment plans or Monitoring Plans, Informed Consent Form (ICF) templates (for both local and central IRBs), site binder contents, etc.
- Contribute to development of clinical trial-related documents
- Work with Clinical Trial Associates (CTAs) and CTM/Director to ensure inspection-ready files by conducting periodic Trial Master File (TMF) QCs.
- Support audit/inspection readiness activities, including but not limited to mock audits, support on-site audits, storyboard generation, documentation of corrective action plans
- Coordinates with CTM to arrange for proper archiving of the clinical trial documents and ensures that TMF and ISFs are completed and meet regulatory standards
- May be asked to assist with CTM activities, such as update study slides, attend vendor meetings
- Other duties may be assigned as deemed necessary by CTM/Director or VP of Clinical Operations, such as provide input to SOPs, Work Instructions or other initiatives
Qualifications & Skills
- Bachelor’s degree life sciences required; science/medical related degree preferred
- Minimum of 2-3 years of related clinical monitoring research experience with at least 1 year of on-site monitoring experience
- Inspection readiness experience, required
- Demonstrates fundamental 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
- Encompasses a general understanding and applies knowledge of country-specific regulations and guidelines required for trial execution
- Demonstrates ability to use core productivity software, collaboration and clinical systems to execute trial activities, and able to identify opportunities to improve systems and processes to increase operational efficiency
- Demonstrates leadership, communication, and organizational skills, along with problem solving, conflict resolution, and team building skills
- Operates with a patient-centric mindset, embedding patient focused practices into day-to-day activities
- Excellent written, oral communication and presentation skills
- Strong interpersonal and communication skills, able to conduct self in diplomatic manner in challenging situations
- Read, write and speak fluent English
- Ability to travel up to 40%
- Enthusiastic and proactive, with a can-do attitude
- Organized, with attention to detail and sound problem-solving skills; aware of the sensitive and confidential nature of information and/or situation; able to think creatively and provide innovative solutions to (non-)standard problems
- Thrives working in a fast-paced environment and able to manage competing tasks and demands with a sense of urgency, comfortable dealing with ambiguity
Core and Technical Competencies
uniQure Clinical Operations has defined at set of core and technical competencies that inform the work we do and how we do it.
These competencies align with our ability to achieve uniQure’s strategic intent, and have been defined for Clinical Operations employees at all career levels in order to provide clear expectations for their current role, where they fit within the organization, and what it looks like to operate at the next level.
Core and technical competency expectations for the In-house CRA role include demonstrating proficiency as an intermediate professional in the following areas:
- Achieve Results
- Professional Maturity
- Plan and Organize
- Problem Solving and Decision Making
- Flexibility and Responsiveness
- Managing and Improving Processes
- Influencing and Persuading
- Strategic Agility
- Managing & Developing People
- Drug Development
- Processes, Procedures and Best Practices
- Regulatory Environment