Centralized Monitoring Coord

Primary Location: Bangalore, India

Full time

 

JOB DESCRIPTION

PURPOSE

Provide project related assistance for assigned project teams. Ensure all work is conducted in accordance with

SOPs, policies, good clinical practices and applicable regulatory requirements. Meeting quality and timeline

metrics.

RESPONSIBILITIES

• Complete appropriate role-specific training to perform job duties.

• Perform assigned tasks to support team members with project execution (examples of such tasks include but

not limited to running system reports, preparing and distributing status reports, creating and maintaining study

documents, etc.).

• Interact with sites/CRA and follow-up of missing data, pending queries, SDV backlog, visit schedule, PD, etc.

• Assist in preparation of i-site pack for respective sites and countries for assigned studies

• Perform the activities as per the task list delegated by Centralized Monitoring Specialist/Centralized

Monitoring Lead.

• Assist in updating and maintaining data in systems within project timelines and per project requirement

• Establish and maintain effective project/site communication

• Create and maintain relevant project documents

• Ensure accurate completion and maintenance of internal systems, databases, tracking tools and project plans

• Act as a backup for Central Monitors

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Good knowledge of applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local

laws, regulations and guidelines.

• Proficient in Clinical Systems (good knowledge on EDC, IXRS, CTMS or equivalent systems).

• Experience of managing global phase trials and clinical trial systems and/or reviewing clinical trial data.

• Strong written and verbal communication skills including good command of English language.

• Results and detail-oriented approach to work delivery and output.

• Good problem-solving skills.

• Good planning, time management and prioritization skills.

• Attention to detail and accuracy in work.

• Good software and computer skills, MS Office applications including but not limited to Microsoft Word, Excel

and PowerPoint.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

• Strong telecommunication skills

• Good data entry skills.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Graduate/Post Graduate in Life Sciences or related field with up to 1 year of relevant experience; or equivalent combination of education, training and experience

• Experience level may vary based on customer specific requirements

PHYSICAL REQUIREMENTS

• Extensive use of keyboard requiring repetitive motion of fingers.

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.

• Regular sitting for extended periods of time.

• May require working in shifts (as applicable)

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