The Senior Clinical Research Associate is responsible for performing trial activities including implementation, monitoring, and summarization of the clinical trials to ensure patient safety and adherence to protocols, ICH-GCP, SOPs, and regulatory requirements. This includes working closely with the clinical trial team to coordinate and ensure the successful completion of the clinical trial according to the trial plan and within the timelines and budget.
This position is key to good communication and professional relationships with Investigators, site staff, and international colleagues in HQs and Affiliates. It is a point of contact and liaison between the Investigators, site staff, and Abeona.
- Reviews protocols and amendments, patient information and informed consent forms, trial manuals, monitoring plan, progress reports, clinical trial reports and other clinical documents as needed.
- Maintains a working knowledge of ICH-GCP Guidelines or other applicable guidance, relevant regulations, and Abeona SOPs/processes.
- Plans and conducts pre-study, site initiation, and monitoring visits. Writes visit reports according to the monitoring plan.
- Conducts site feasibility checks, designs and implement training to site’s personnel and assess the trial site and applicable personnel on an ongoing basis.
- Communicates with investigators and site staff, and ensure compliance with protocols, regulatory requirements, and good clinical practices
- Uses judgment and experience to evaluate overall performance of an Investigator and site staff and provides recommendations regarding site-specific actions
- Immediately communicates/escalates serious issues to the clinical trial team and develops action plans.
- Assists site staff with internal audits or regulatory inspections, if applicable.
- Track site performance applying metrics standards.
- Drafts an appropriate intervention plan for the avoidance of redundant errors and deviations.
- Verifies the receipt, handling, accounting, storage conditions, and availability of IMP and other trial materials
- Verifies the integrity of investigator site files, ensuring the availability of clinical and non-clinical materials, maintain the required documentation in the Trial Master File according to Abeona standards and applicable guidelines, and check for consistency with Abeona’s Trial Master File.
- Ensures compliance with the procedures to apply in the event of serious adverse events.
- Contributes with the project plan and monitor related budgets and resources allocation in collaboration with the clinical trial managers
- Performs ongoing follow-up with the in-house clinical trial team.
- Prepare/review clinical documentation and ensure on time availability of critical documents and progress reports.
- Anticipate, recognize and resolve issues proactively with the project team.
- Jointly review with investigators the obligations inherent at the end of the trial and writes closure visit reports.
- Bachelor’s degree, preferably life sciences or healthcare
- 4+ years on-site monitoring experience within a pharmaceutical, biotechnology, and/or CRO setting
- Comprehensive and practical knowledge of the principle of clinical trial conduct in accordance with ICH-GCP and other clinical trials-related regulations or guidelines.
- Thorough knowledge of clinical development processes and conduct of clinical studies.
- Awareness of global regulatory and pharmacovigilance environments.
- Experience collaborating with Investigators, site staff and CROs.
- Experience in EC & CAs submission preparation.
- Professional proficiency in both spoken and written English.
- Experience in rare disease and/or gene therapy (preferred).
Personal skills & abilities
- Strong written and verbal communication skills.
- Strong organizational and time management skills with the ability to handle multiple studies and aggressive timelines.
- Quality oriented with attention to details.
- Highly proactive, self-motivated, professional and dedicated.
- Demonstrated computer skills (MS Office, EDC, IXRS, eTMF & CTMS preferred).
- Ability to drive and willingness to travel for trial monitoring and auditing.
The level of this position will be based on the final candidate’s qualifications.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.