POSITION SUMMARY

The Senior Clinical Research Associate (Sr. CRA) is a high-impact, primarily in-house role responsible for the day-to-day operational integrity of XII Medical’s clinical studies. Working with a high degree of independence and cross-functional accountability, the Sr. CRA owns a broad portfolio of study management functions—spanning electronic data capture, Trial Master File stewardship, regulatory and ethics authority interactions, site-level operational support, and external stakeholder liaison—ensuring studies are conducted to the highest standards of quality, compliance, and efficiency. The Sr. CRA is expected to proactively identify operational risks, drive continuous process improvement, and serve as a reliable subject matter resource for study teams and investigative site staff. Domestic and international travel to investigational sites, investigator meetings, and sponsor or vendor locations is required on an as needed basis (up to 25%).

KEY RESPONSIBILITIES

Electronic Data Capture (EDC) System Ownership & Data Management

• Serve as the primary in-house owner of the EDC system; manage user provisioning, system configuration, and version updates in close coordination with the EDC provider and relevant internal stakeholders.
• Conduct structured weekly electronic data reviews to identify missing, out-of-range, or inconsistent entries; generate, assign, and track data clarification forms (DCFs) and queries through resolution in collaboration with investigative sites and the Data Management team.
• Act as the principal liaison between clinical operations, the Data Management group, and the EDC vendor; facilitate investigative site training, user onboarding, and ongoing troubleshooting for all EDC users.
• Oversee ongoing EDC maintenance including edit check updates, CRF version management, and user guide revisions; support database freeze, lock, and unlock activities, and coordinate audit-trail reviews.
• Contribute to EDC build review and user acceptance testing for new studies or protocol amendments; ensure CRF design remains aligned with protocol requirements and the data management plan throughout the study.

Trial Master File (TMF) Maintenance, Review & Inspection Readiness

• Maintain and routinely review the electronic and/or paper TMF to ensure completeness, accuracy, and inspection-readiness at all times, in accordance with applicable TMF reference models (e.g., DIA TMF Reference Model) and ICH E6(R2)/R3 GCP guidelines.
• Track, file, and version-control all ethics (HREC/IRB) and regulatory authority (RGO) approvals, correspondence, formal interactions, and decisions; ensure site-level regulatory packages are current and consistently archived.
• Coordinate and prepare submissions for protocol amendments, substantial modifications, and deviations; manage submission timelines and maintain comprehensive amendment logs and HREC/RGO interaction records.
• Manage annual progress reports and renewal submissions to ethics bodies and regulatory authorities; maintain a forward-looking submission calendar and coordinate timely content preparation with clinical and medical affairs teams.
• Ensure all safety reporting obligations (SAEs, device deficiencies, periodic safety reports) are met within required timeframes for all applicable regulatory and ethics authorities; maintain safety reporting logs and correspondence files.
• Conduct periodic TMF gap analyses and inspection-readiness self-assessments; implement corrective actions and escalate identified risks to clinical operations leadership.

Site Operational Support, Screening & Device Accountability

• Own and maintain study-wide screening schedules and subject logs; coordinate with site staff to capture screen failures, enrollment status, and subject disposition data in real time, ensuring accurate reflection in study tracking systems.
• Maintain device accountability records and field inspection documentation for all investigational devices; reconcile accountability logs against shipment, return, and destruction records at each accountability point.
• Develop and maintain the investigational site contact directory and escalation matrix; serve as the primary operational point of contact for routine site queries and direct complex issues to the appropriate functional owner.
• Support site initiation, co-monitoring, interim monitoring, and close-out activities as schedule and travel allow; review site-generated documentation packages for GCP compliance and completeness.

Sponsor, Regulatory & External Stakeholder Liaison

• Serve as the primary in-house interface with the local sponsor organization; manage day-to-day communications, document exchange, meeting coordination, and issue escalation to maintain alignment with sponsor expectations and study milestones.
• Interface with core laboratories to coordinate sample shipment logistics, lab manual distribution, kit resupply, and resolution of sample-related discrepancies; maintain current core lab service agreements and contact information.
• Manage and maintain public study postings across applicable registries (e.g., ClinicalTrials.gov, ANZCTR, WHO ICTRP) including initial registration, protocol updates, recruitment status changes, and results reporting in compliance with regulatory and sponsor requirements.
• Support preparation for and participation in regulatory authority inspections, sponsor quality assurance audits, and Notified Body assessments; coordinate document retrieval, response tracking, and corrective action follow-up.

Study Communications, Newsletters & Meeting Coordination

• Draft, coordinate internal review of, and distribute study newsletters and site-directed communications; ensure content accuracy and compliance with applicable confidentiality and regulatory requirements prior to distribution.
• Prepare investigator meeting agendas, training materials, and protocol update communications in collaboration with clinical operations and medical affairs; coordinate logistics and track action item follow-up post-meeting.
• Maintain study-level action item logs arising from team meetings, monitoring visits, data reviews, and sponsor interactions; proactively follow up on open items and escalate unresolved risks to clinical operations leadership.
• Contribute to the preparation of internal clinical study status reports, enrollment dashboards, and operational metrics summaries for leadership and cross-functional review.

Senior-Level Clinical Operations Contributions

• Contribute substantively to the development, review, and revision of study protocols, informed consent documents, case report forms, study procedures manuals, monitoring plans, and other key study documents.
• Support vendor selection, onboarding, and ongoing oversight activities, including review of vendor work orders, performance metrics, and issue escalation to ensure delivery against contracted scope.
• Provide mentorship, day-to-day guidance, and work product quality review for junior CRAs, clinical research coordinators, and operations support staff; contribute to onboarding and training program development.
• Monitor evolving GCP regulations, ICH guidelines, FDA and international regulatory agency guidance, and device-specific clinical research requirements; proactively communicate compliance implications and propose process improvements.

REQUIRED QUALIFICATIONS

• Bachelor’s degree in life sciences, nursing, health sciences, or a closely related field; advanced degree a plus.
• 5+ years of clinical research experience with at least 3 years in a CRA, in-house CRA, or clinical study management role at a sponsor, CRO, or equivalent organization; medical device experience strongly preferred.
• Demonstrated hands-on experience as a primary EDC user or system owner (e.g., Medidata Rave, Oracle InForm, Veeva Vault EDC, REDCap, or equivalent); prior EDC super-user or administrator experience highly desirable.
• Solid working knowledge of ICH E6(R2)/R3 GCP, applicable FDA regulations (21 CFR Parts 812, 50, 54, 56), ISO 14155, and relevant international clinical research requirements.
• Meaningful hands-on experience maintaining, auditing, and preparing TMFs for inspection against a recognized reference model (e.g., DIA TMF Reference Model).
• Experience with ethics committee and regulatory authority submission processes including initial applications, amendments, annual renewals, and safety reporting obligations.
• Experience managing or contributing to public clinical trial registry postings and maintaining compliance with registration and results reporting requirements.
• Exceptional organizational skills with demonstrated ability to manage multiple concurrent workstreams, prioritize effectively under competing deadlines, and operate independently with minimal supervision.
• Excellent written and verbal communication skills; proven experience drafting regulatory correspondence, study communications, newsletters, and operational reports for diverse audiences.
• Proficiency with Microsoft Office Suite; comfort with eTMF platforms, CTMS, and other clinical study management systems.

PREFERRED QUALIFICATIONS

• Experience in cardiac rhythm management, neuromodulation, or implantable device clinical trials.
• Familiarity with Australian/New Zealand or other international regulatory and ethics frameworks, including TGA requirements and HREC/RGO submission processes.
• Experience with core laboratory interfaces and management of biologic sample logistics within a device or combination product trial.
• ACRP (CCRA or CCRC), SOCRA (CCRP), or equivalent professional certification.
• Experience supporting or coordinating documentation for regulatory authority inspections (e.g., FDA, TGA, MHRA) or sponsor quality audits.
• Familiarity with risk-based monitoring (RBM) approaches, central statistical monitoring tools, and associated data review methodologies.
• Experience contributing to study startup activities, integrated clinical development planning, or investigational device exemption (IDE) submissions.