Overview: Position Summary: 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.

Qualifications:

• Bachelor’s degree required, preferably in nursing, life or health sciences; advanced degree preferred.
• Adequate experience as a CRA I, performing administrative and on-site monitoring on a variety of studies, or equivalent experience is required.
• At least 2 years or more as a CRA I or equivalent position is preferred.
• Must be proficient in Microsoft Office, virtual communication platforms and other technology required. Articulate, professional, and able to communicate in a clear, positive fashion with clients and staff.
• Experience in gene therapy, rare/orphan diseases highly desirable.

• Thorough knowledge of all clinical trial conduct and site management/site monitoring activities (startup through close-out) using ICH/GCP.
• Availability to conduct independently site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

• 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.
• Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS and EDC) and ensuring timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
• 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.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Site support throughout the study lifecycle from site identification through close-out.
• Knowledge of local requirements for real world late phase study designs.
• Chart abstraction activities and data collection.
• Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
• Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
• Collaboration with other team members about local country requests.
  The CRA II may be requested to train junior staff.
• Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations

• Fluency in English besides the local language.
• Ability to adapt to a dynamic environment.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills and be able to embrace new technologies.
• 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, Power Point, Outlook & Teams), Share Point.
• Work well within a team setting, proactively.
• Excellent communication, presentation and interpersonal skills.

Compensation: EEO Statement: