Clinical Research Associate Job in Mumbai

There are vacancies for Clinical Research Associate in Cavance.

Organization : Cavance
Job Title : Clinical Research Associate
Location : Mumbai
Qualification : University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
Experience :  Minimum 18-months of clinical research experience including demonstrated competency in site monitoring (including pre-study, initiation, routine monitoring and closeout visits). 

Job Responsibility :

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance; liaise with vendors; and other duties, as assigned.
• General On-Site Monitoring Responsibilities:

1. Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
2. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. 
3. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data.
4. Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy.
5. Prepare accurate and timely trip reports.

• Responsible for aspects of site management as prescribed in the project plans.
• Responsible for aspects of registry management as prescribed in the project plans.
• Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management.
• Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management.
• Provide coverage for clinical contact telephone lines, as required.
• Update, track and maintain study-specific trial management tools/systems.
• Generate and track drug shipments and supplies, as needed.
• Track and follow-up on serious adverse events as assigned.
• Implement study-specific communication plan as assigned.
• Attend investigators’ meetings, project team meetings and teleconferences, as needed.
• Assist Senior CRA in managing investigator site budgets.
• Perform other duties as assigned by management.

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