Clinical Research Associate I

Primary Job Function:

The Site-ICRA I, based in India, is primarily responsible for support services in partnership and collaboration with the US and EMEA Clinical Site Operations team. Primary focus is on providing and leading support of site management activities such as collection of essential site regulatory documents by reviewing and analyzing regulatory documents for accuracy and completeness per Good Clinical Practice (GCP) and Good Documentation Practice (GDP) standards and support creation of patient and regulatory binders. Updates and maintains internal clinical trial information and document management systems. Maintain local regulatory documents on paper or electronically as applicable and ensure upload to data management system (Study Organizer, SO), as applicable.

Core Job Responsibilities:

• Primary focus is on providing and leading support of site management activities such as collection of essential regulatory documents.
• Reviews and analyzes regulatory documents for accuracy and completeness per Good Clinical Practice (GCP) and Good Documentation Practice (GDP) standards.
• Updates and maintains internal clinical trial information and document management systems. Maintain local regulatory documents on paper or electronically as applicable and ensure upload to data management system (SO).
• Supports creation of patient and regulatory binders throughout the study lifecycle.
• Supports regulatory and clinical protocol compliance for all clinical projects at the assigned sites.
• Drives collaboration with site partners with Site Management and Operationstoaddress Business Unit deliverables such as supporting the follow-up and resolution of findings from monitoring visits and audits, when requested.
• Communicates and collaborates with all levels of employees, customers, contractors, and vendors.
• Performs review of site compliance under supervision and escalates issues to site operations management and/or study management.
• Updates and maintains internal clinical trial information and document management systems.
• May contribute to global or regional process improvements.
• Have a good understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education about Abbott devices and therapies.
• Clinical inventory management with site and local warehouse. Liaison between site, global project management, Device Accountability Specialist, local warehouse, and local customer service.
• Manage import and export processes per local regulations and applicable Abbott work instructions and SOPs.
• Initiates translations of study and site level documents as applicable, including the Patient informed consent, and other study documents, as requested.
• May make additional contributions as assigned.

Position Accountability/Scope:

• Primary focus and accountability will be providing support of site management activities such as collection of essential site regulatory documents by reviewing and analyzing regulatory documents for accuracy and completeness per Good Clinical Practice (GCP) and Good Documentation Practice (GDP) standards and device inventory management activities as described above with oversight and support by the US and EMEA Clinical Site Operations leadership team.
• Clinical inventory management with site and local warehouse. Liaison between site, global project management, Device Accountability Specialist, local warehouse, and local customer service, including managing the import and export processes per local regulations and applicable Abbott work instructions and SOPs.
• Initiates translations of study and site level documents as applicable, including the Patient informed consent, and other study documents, as requested.

Minimum Education:

Bachelor's degree preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering with a minimum of two years of experience, or an equivalent combination of education and experience

Minimum Experience/Training Required:

Must have strong written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to interpret basic clinical data, to meet deadlines as well as the ability to communicate effectively with all levels of employees.

Must be proficient in Microsoft Office Suite.

Able to work independently, seeking guidance when necessary.

Capable of exchanging information, ask questions, and check for understanding

Preferred:

A general familiarity with clinical trials research processes. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment.

Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP), or equivalent clinical research certification.

Work habits include organization, coordination of many tasks, accuracy, and attention to detail