Piramal Enterprises hires for the post of Clinical Research Associate!

Piramal Enterprises Limited - NCE research unit focuses on the discovery and development of new drugs to treat unmet medical needs in the areas of cancer, metabolic disorders, inflammation and infectious diseases. The Company's focused and well defined business strategy has enabled it to successfully identify promising candidates and build a robust pipeline of molecules at various stages of preclinical and clinical development. Piramal Enterprises intends to harness India's skills in research based activities to develop products which will be marketed and sold worldwide either independently or through collaboration with leading pharmaceutical companies. 

Name of the post: Clinical Research Associate

Job Responsibilities:

The responsibility of a CRA is to conduct monitoring visits at assigned sites to ensure high quality data is collected and that the study protocol is conducted in accordance with Piramal, standard operating procedures, Good Clinical Practice, and applicable regulatory requirements.

Key Accountabilities:

Primary Deliverables:

• Circulation of Feasibility Questionnaires to sites
• Perform Site Assessment, Initiation, Monitoring and Close-out visits; generate visit reports & follow-up letters in accordance with monitoring plan.
• Ensure the completion of action items of each visit as per the decided timelines.
• Manage the progress of assigned studies by tracking regulatory/EC submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• To ensure DCF turnaround time is as per the Data Management Plan.
• Administer protocol and related study training at the onset and at periodic intervals to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• To ensure that CSF & ISF are updated on a regular basis by collection & review of essential documents from applicable stakeholders. 
• To perform quality check of all site documents (e.g. EC approval, IPRF)
• Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol Violations.
• To follow internal process of finance tracking and ensuring site payments are made as per the CTA.
• Any concerns or ongoing quality issues should be escalated to Management as appropriate.
• Assistance in audits and keeping the sites in a state of audit-readiness at any given point of time.
• Identify new investigators/sites which can be a part of PHL database to conduct clinical trials.
Secondary Deliverables:
• May assist in study budget negotiations with investigators & in execution of CDA/CTA/MSA with investigator sites.
• May assist in regular coordination with vendors example Translation Agency, Printers, Site infrastructure Vendors (for Calibration of instruments/procurement of Thermohygrometer etc).
• Attend staff meetings and training sessions as required
• Build relationships with investigators and site staff
• Update all relevant tracking systems on an ongoing basis.
• Track the supplies at site and ensure there is no shortage at any given point of time.
• To perform other study related tasks as assigned by the supervisor but not limited to above mentioned study related task.
• Job location: Mumbai
  Educational qualification: B.Pharma/M.Pharma
  Experience: 1-3 years
  Desirable:
  1. At least 1 year of experience in clinical studies monitoring
  2. Preferably worked in oncology therapeutic studies
  How to apply:
  Interested eligible candidates can send in their resumes to tushar.shinde@piramal.com