Clinical Research Associate
vor 1 Woche
We are seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials.
Key Responsibilities:- Schedule, plan, and conduct site visits to ensure compliance with regulatory requirements and study protocols.
- Write and submit reports and investigator follow-up letters to ensure timely and accurate communication with sites.
- Manage the progress of assigned studies by tracking regulatory/IRB submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution.
- Provide project updates to the project management team to ensure seamless communication and collaboration.
- Organize the delivery of investigational product, laboratory supplies, CRFs, and other study-specific materials to and from clinical sites.
- Perform investigational product inventory and ensure the return of unused investigational product to the designated location or verify destruction as required.
- Assist with, prepare for, and attend investigator meetings for assigned studies.
- Review study documents for compliance with protocol, ICH GCP guidelines, protocol deviations/violations, and waivers, and review study documents for subject safety events; escalate issues at site to project management.
- Collect and review essential study documents from sites for filing in eTMF.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the study and ensure adherence to applicable regulations.
- Compliance: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participate in the planning of quality assurance activities and coordinate the resolution of audit findings.
- Assist the Clinical Trial Manager with clinical operations activities by overseeing resource allocation, reviewing site performance, providing feedback to CRAs and CTAs, resolving issues, performing review and oversight of site visit reports.
- May review protocols, eCRFs, study manuals, and other study-related documents, as requested by the Clinical Trial Manager.
- May conduct on-site evaluation visits and on-site training of CRAs.
- Lead and participate in regular team meetings/teleconferences.
- Assist, as appropriate, with reporting site performance regarding timelines and deliverables during project team meetings and assist with providing and compiling feedback for analysis of overall study performance.
- May serve as a mentor to associates on the subject of job performance, trainings, and professional growth.
- Bachelor's degree in biomedical sciences or a related scientific discipline.
- Fluent English (oral and written) and applicable local business language.
- Minimum three years of monitoring experience, more experience preferred, with a combination of clinical research coordinator and/or other relevant clinical research experience.
- Sound knowledge of medical terminology and advanced proficiency in clinical monitoring process.
- Ability to travel up to 70%, depending on project requirements.
- Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements.
- Excellent verbal, written communication, and presentation skills.
- Good leadership, planning, project management skills, verbal communication skills, and written communication skills.
- Knowledge and experience with MS Office suite (at a minimum Word, PowerPoint, and Excel).
If you have the experience required and want to join a dynamic and collaborative team, please apply directly to our website at https://biorasi.com or email us at careers@biorasi.com.
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