Site relationship management role ensuring sustainable trial start - up for assigned sites in clinical drug development at Novartis. Collaborating with global teams and ensuring adherence to clinical operations standards and timelines.
About the role
- Clinical Research Associate 2 at Emerald Clinical overseeing clinical trials and conducting site management activities. Ensuring compliance with regulatory requirements and quality standards in clinical research.
Responsibilities
- Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.
- Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe.
- Prepare, plan, organize, and conduct site evaluation visits and report on these visits to assist in site selection.
- Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages.
- Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments.
- Prepare, plan, organize, and conduct site initiation visits.
- Develop and maintain appropriate monitoring tools and project-specific documents.
- Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines.
- Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing.
- Reconcile contents of in-house TMF and site’s Investigator Site Files.
- Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements.
- Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial.
- Support strategies to boost recruitment efforts.
Requirements
- Tertiary qualifications in a related science or health care discipline.
- Previous experience in clinical trials within an academic, CRO, or pharmaceutical environment with 2-5 experiences in on-site monitoring and site management experience is mandatory.
- Demonstrate practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements.
- Display competence in the following technical areas: ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.
- Demonstrate competence in the following business skill areas: negotiation and conflict resolution, critical thinking, problem-solving, decision making, and strategic thinking.
- Demonstrate solid interpersonal communication, presentation skills, and flexibility to work well within a multi-disciplinary team both autonomously and with a wide range of varying stakeholders.
- Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments.
- Ability and willingness to travel.
Benefits
- Competitive Compensation : A tailored salary and benefits package to reflect your skills and experience.
- Flexibility : Enjoy hybrid or remote working arrangements, depending on your location and role.
- Career Growth : Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
- Employee Wellbeing : Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
- Global Opportunities : Be part of a company with international reach, offering you exposure to diverse projects and clients.
Job title
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