Clinical Trial Associate

Concept Medical Inc.; Surat; On-site; INR 350,000 - 520,000; Full time

Job summary

Concept Medical Inc. in Surat, Gujarat, is seeking a Clinical Trial Associate to provide administrative support across the full spectrum of research activities, including pre-clinical research, study start-up, management, and site closure.

You will assist the Project Manager and CRAs with updating systems, handling study documents, and ensuring audits readiness, while maintaining timelines and quality. Ideal candidates have a clinical background degree or equivalent experience, strong

Qualifications

• Equivalent experience degree in a Clinical Background.
• 2-3 year professional Clinical Background experience.
• Excellent oral and written communication skills.
• Professional in-depth knowledge of regulations in the Medical Device industry.

Responsibilities

• Assist Project Manager and CRAs with updating and maintaining clinical systems that track site compliance and performance within project timelines.
• Assist the clinical team in preparing, handling, distributing, filing, and archiving clinical documentation and reports according to SOPs.
• Assist with periodic review of study files for accuracy and completeness.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Process Data Collection Forms, i.e., login, tracking, quality control as appropriate for the study.
• Assist in preparing Quality management system documentation and preparation for audits.
• Provide general administrative support to the Clinical Operations Department.
• Assist the Clinical teams in the completion of all required tasks to meet departmental and project goals.

Skills

Oral communication

Written communication

Attention to detail

Education

Clinical background degree or equivalent experience

Job description

The Clinical Trial Associate provides administrative support to the clinical research teams in the full spectrum of the research activities such as pre-clinical research, study start-up, study management and site closure.

Clinical research associates help to organize and monitor the different phases of clinical trials. Key responsibilities include:

Responsibilities And Duties:

• To assist Project Manager and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
• To assist the clinical team in preparing, handling, distributing, filing, and archiving clinical documentation and reports according to the scope of work and standard operating procedures.
• To assist with periodic review of study files for accuracy and completeness.
• To assist with the tracking and managing Case Report Forms (CRFs), queries and clinical data flow.
• To process Data Collection Forms, i.e. login, tracking, quality control as appropriate for the study.
• To assist in preparing Quality management system documentation and preparation for audits.
• To provide general administrative support to the Clinical Operations Department.
• To assist the Clinical teams in the completion of all required tasks to meet departmental and project goals.
• To set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.), including preparation for internal/external audits, final reconciliation and archival.
• To assist in the coordination of Investigator payments, if applicable.
• To assist in producing slides, overheads, etc., as needed for the project, departmental, sponsor and business development presentations.

Qualifications:

• equivalent experience degree in Clinical Background.
• 2-3 year professional Clinical Background experience
• Excellent oral and written communication skills,
• Professional in-depth knowledge of regulations in the Medical Device industry.