Location: New York, NY
Salary: $70,000 to $100,000
Our client is a diverse pharmaceutical company that is committed to focusing on their key stakeholders while delivering consistently high performance.
- Contribute in the design of clinical trials, and review trial documents including but not limited to study protocols and amendments, patient information and informed consent forms, study manuals, monitoring plan, progress reports, clinical trials reports.
- Perform a comprehensive checklist of study requirements.
- Conduct pre-study visits and drafts pre-study evaluation reports.
- Conduct site feasibility checks, designs and implement training to site’s personnel and assess the trial site and applicable personnel on an ongoing basis.
- Conduct site-initiation visits and writes initiation visit reports.
- Perform monitoring in the field.
- Communicate with investigators and their staff, and ensure compliance with protocols, regulatory requirements, and good clinical practices.
- Perform on-site data verification, data integrity and monitor CRF completion and queries.
- Assist site personnel with internal audits or regulatory inspections, if applicable.
- Track site performance applying metrics standards and write follow-up visit reports.
- 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 study materials in collaboration with the assigned resources.
- Verify the integrity of investigator files, ensuring the availability of clinical and non-clinical materials, maintain the required documentation in the Trial Master File according to the company standards and applicable guidelines, and check for consistency with the contents of sponsor files.
- Ensures compliance with the procedures to apply in the event of serious adverse events.
- Jointly review with investigators the obligations inherent at the end of the study and writes closure visit reports.
- Contribute with the project plan and monitor related budgets and resources allocation in collaboration with the clinical study managers.
- Perform ongoing follow-up with the in-house clinical project 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.
- BSc degree in life sciences.
- Experience in EDC & CTMS is required.
- Experience study start up is required.
- Minimum 4 years of CRA experience in a pharmaceutical company or a CRO with on-site monitoring activities.
- 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.
- Knowledge of global regulatory and pharmacovigilance environments.
- Experience in coordinating collaboration with investigative centers, clinical staff and CROs.
- Experience in EC & CAs submission preparation.
- Professional proficiency in both spoken and written English.
- Experience in contracts negotiation is a plus.
- Excellent communication skills.
- Strong organizational and time management skills.
- Quality oriented with attention to details.
- Highly proactive, self-motivated, professional and dedicated.
- Excellent computer skills.
- Ability to drive and willingness to travel for study co-monitoring and auditing.
- Experience working in cross-functional teams (Data Management, Bio Statistics, Regulatory etc.)