The Senior Clinical Research Associate 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 operational input during protocol development, oversight of study conduct, and interpretation of study results.  

• Perform site monitoring visits (site-selection, initiation, interim monitoring visits, and close out) in accordance with the Study Monitoring Plan, regulatory requirements, and ICH/GCP ensuring quality standards are met throughout the course of the trial.
• Responsible for clinical site monitoring deliverables (e.g., monitoring source identification, on-site/remote monitoring, centralized monitoring, data collection/entry/cleaning, investigator/site compliance and issue management etc.).
• Lead site-level clinical study 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.
• Administer protocol and study related training to the assigned sites and ensure appropriate training throughout the course of the study.
• Accountable for assigned sites for clinical monitoring performance of regulated clinical trials, including inspection readiness; responsible to ensure timely resolution of action and follow up items; 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 through proper approval and escalation channels. 
• Assist clinical sites in preparation for Quality Assurance audits and/or regulatory authority inspections. 
• In collaboration with internal stakeholders, facilitate feasibility, site-qualification, 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.
• Evaluate the quality and data integrity of the site practices and adherence to the protocol and applicable regulations.
• Manage tracking of regulatory submission and approvals, recruitment and enrollment, CRF completion, and data query generation and resolution.
• Contribute to Monitoring Plan, complete visit reports, follow up letters as well as other site management and monitoring documents and tools such as the Veeva CTMS platform to manage subject visits and reconsents.
• Collect and file all site required documents in the Veeva TMF system.
• 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.

• Bachelor’s degree in scientific discipline or health care required; advanced degree preferred.
• 6+ years’ clinical research or equivalent healthcare experience with clinical site management and monitoring experience.
• 4+ years of direct onsite clinical monitoring experience is required.
• Experience in gene therapy and/or rare/orphan disease is required.
• In depth knowledge of, and skill in applying, applicable local regulatory requirements, i.e. ICH/GCP.
• Experience with all aspects of clinical trial conduct (startup through close-out) is required.
• Excellent written and verbal communication skills including good command of English.
• Must be fluent in both written and spoken German.
• Proficiency in Microsoft Word, Excel, PowerPoint, OneNote is required.
• Proficiency or ability to learn Veeva platform is required.
• Ability to troubleshoot site-related issues and provide solutions and mitigation strategies.
• Prior demonstrated experience serving as a monitoring/study lead.
• Demonstrated excellence in a dynamic, complex environment and effective site management of multiple projects/priorities.
• Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
• 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.