Clinical Research Associate - Spain

Madrid /
Clinical Operations – Clinical Operations /
Full Time
/ Remote
Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues.  We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

The Clinical Research Associate (CRA) will work in close collaboration with cross-functional clinical, regulatory, safety and manufacturing team members, academic partners, and external vendors. This position reports through the Clinical Operations function which is accountable for overall clinical execution and provides scientific input during protocol development, oversight of study conduct, and interpretation of study results. 

Responsibilities:

    • Assigned to clinical sites across multiple Rocket programs to support and oversee the clinical site management and monitoring function, in accordance with ICH GCP, to ensure quality standards are met and maintained throughout the course of the trial. 
    • Responsible for clinical site monitoring deliverables (e.g., monitoring source identification/selection, on-site/remote monitoring, centralized monitoring, data collection/entry/cleaning, investigator/site compliance and issue management etc.).
    • Lead site-level clinical site management and monitoring oversight related to risk identification, management, and mitigation efforts and report progress to senior leadership, and applicable study teams, per appropriate escalation pathways and internal standard processes.
    • Accountable for assigned sites for clinical monitoring performance of regulated clinical trials, including inspection readiness; responsible to implement regular quality checks to ensure adequate and timely resolution of reporting safety issues and protocol deviations; in addition, timely follow-up, and escalation of, any outstanding issues. 
    • Facilitate the execution of startup activities and study maintenance (eg, collection of regulatory documents and ethics submissions, shipment of supplies and equipment, vendor training/access to vendor portals, etc); to ensure site readiness and study maintenance.  
    • Troubleshoot site issues and escalate appropriately. Determine viable solutions and institute corrective action plans, as needed, and manage through the process of resolution. 
    • Assist clinical sites in preparation for Quality Assurance audits and/or regulatory authority inspections. 
    • In collaboration with internal stakeholder, facilitate feasibility and site-selection activities at the site level whenever necessary; provide input into investigator/site identification, capabilities, and selection.  Act as sponsor point of contact for escalation of any recruitment obstacles/challenges.
    • Assist and support with proactively planning for site visits by collaborating with senior management and study teams; verify that initial and ongoing site training/certification requirements are being met and documented.
    • Perform prospective and retrospective reviews of data and reports (remote and onsite) to identify areas of risk, gaps in processes, operational challenges around the protocol assessments, and trends across sites and programs, reporting these findings and providing a comprehensive risk assessment to leadership and study teams with the goal of improving overall performance and quality. 
    • Contribute to Monitoring Plan, annotated visit reports, as well as other site management and monitoring documents and tools.
    • Build collaborative long-term relationships/partnerships with clinical investigators, as Rocket Clinical Operations representative, with sites, vendors, and business partners.
    • Create an environment of quality site performance, accountability, transparency, and trial success through Rocket and investigative site collaboration.
    • Perform additional site management and study management tasks to support applicable Study Operations teams, as assigned by Clinical Operations management.

Requirements:

    • Bachelor’s degree required, preferably in nursing, life or health sciences; advanced degree preferred.
    • 2-3 years’ clinical research experience in the pharmaceutical or biotech industry or equivalent healthcare experience
    • 1 year direct clinical monitoring and/or site management experience preferred, but previous experience as a Clinical Research Coordinator or similar experience may be considered in lieu of this industry experience.
    • Experience in gene therapy, rare/orphan disease highly desirable.
    • Thorough knowledge of all clinical trial conduct and site management/site monitoring activities (startup through close-out) using ICH/GCP.
    • Understanding of the overall drug development process.
    • Ability to troubleshoot site-related issues and provide solutions and mitigation strategies.
    • Demonstrated excellence in a dynamic, complex environment and effective site management of multiple projects/priorities.
    • Demonstrated experience with EDC and eTMF platforms is preferred
    • Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
    • Experience in regulatory filings (e.g., NDA, BLA, MAA) highly desired.
    • Ability to adapt within a dynamic environment
    • Outstanding organizational, time management, planning and record keeping skills.
    • Advanced communication (oral & written), interpersonal and negotiating skills
    • Ability to analyze, evaluate and prioritize key issues and problems, and subsequently seek-out and recommend possible solutions and mitigation strategies before escalation.
    • Proficient in MS Office tools (Excel, Word, PowerPoint, Outlook & Teams), SharePoint.
    • Work well within a team setting, proactively
    • Travel Requirements:  Ability and willingness to travel up to 70% of the time, as needed
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

Full COVID-19 vaccination is required for employment at Rocket Pharmaceuticals.