Clinical Research Associate

1 week ago


Gandhinagar, Gujarat, India Eccentric Clinical Research Pvt Ltd Full time

Job Summary


We are seeking Clinical Research Associate to join our reputable Contract Research Organization (CRO) and be CRA will be responsible for managing clinical study related activities and documentation of studies conducted in India.

In this crucial role, you will play a key part in maintaining regulatory compliance, conducting monitoring, and driving continuous improvement efforts.

Additionally, as a member of our Clinical Operations Team, you will contribute to the overall success of our organization by providing exceptional support to our clients and stakeholders.


About Us


We are a comprehensive Clinical Research Organization that offers a complete range of services to sponsors, covering every aspect from protocol development to the final submission of Clinical Study Reports (CSRs).

The Eccentric Clinical Research is a trusted firm that specializes in providing clinical research services within India. Our extensive service portfolio includes clinical operations, site monitoring, data management, regulatory affairs, medical writing, and quality assurance.

As experienced clinical research consultants, we assist our clients with proficient management of their clinical research projects and expert regulatory guidance.

From project proposal evaluation to the successful completion of clinical trials, including necessary clearances and documentation, we provide continuous support and guidance to our clients at every stage of their projects.


Job Description:

  • Conduct the sites visits
  • Site Selection, Site Initiation, Interim Monitoring, Site Close Out
  • Perform site monitoring visits to include review of source document, CRF, ICD, Patient Diary, Site TMF, other documents as applicable
  • Monitor study process to ensure compliance with study protocol requirements, applicable regulatory regulations, GCP guidelines and internal processes
  • Monitor and track patient enrollment and study progress
  • Ensure timely, accurate and complete collection and submission of study data
  • Maintain TMF and other internal documentation as per applicable internal processes
  • Prepare the site for possible regulatory inspection/ internal audits
  • Ensure 100% adherence to the monitoring and study plan
  • Follow up on outstanding issues at the sites & assist sites to get them closed
  • Support the clinical quality in managing CAPA's and other study audit observations
  • Support the Project Manager / Operational Lead in performing study/CRO oversight activities till study completion
  • Handle and manage team of CRC's specific to allotted study
  • Ensure collection of all data and remaining study supplies for return
  • Ensure that appropriate study documents are complete and properly filed
  • Archival with inventory list of source documents/ CRFs/ CTM/ Other at site
  • Any other activities related to role as may be required based on business need from time to time

Skills and Abilities:

  • Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts
  • Good knowledge of word processing, spreadsheets, table and graph generation and use of applicable computer software
  • Working knowledge of industry regulations, ICH or other regulated environments
  • Effective written and oral communication skills
  • Time management skills
  • Ability to work well in a collaborative team environment
  • Good working knowledge of GCP and Clinical Trial Rules and regulations

Job Types:
Full-time, Regular / Permanent

Salary:
From ₹500,000.00 per year

Benefits:

  • Health insurance

Schedule:

  • Day shift
  • Monday to Friday

Ability to commute/relocate:

  • Gandhinagar, Gujarat: Reliably commute or willing to relocate with an employerprovided relocation package (preferred)

Education:

  • Master's (preferred)

Experience:

  • Patient monitoring: 3 years (preferred)

Language:

  • English (preferred)

Willingness to travel:

  • 50% (preferred)

Speak with the employer
Expected Start Date: 01/08/2023

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