CRA/ Sr.CRA/ Medical Writer/ Data Management at MediClin CR
MediClin is a leading contract research organization (CRO)
which is having corporate office in Mumbai providing comprehensive, integrated
drug development and product lifecycle management services. Our clients and
partners include pharmaceutical, biotechnology, medical device, and government
organizations.
Post: CRA/ Sr.CRA/ Medical Writer/ Data Management
Job Description
Perform site selection (if applicable), initiation,
monitoring and close-out visits in accordance with contracted scope of work and
good clinical practice.
• If applicable, may be accountable for supporting
development of project subject recruitment plan on a per site basis. Work with
sites to adapt, drive and track subject recruitment plan in line with project
needs to enhance predictability.
• Provide monitoring visits and site management for a variety
of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned
sites and establish regular lines of communication with sites to manage ongoing
project expectations and issues.
• Evaluate the quality and integrity of study site practices
related to the proper conduct of the protocol and adherence to applicable
regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking
regulatory submissions and approvals, recruitment and enrollment, case report
form (CRF) completion and submission, and data query generation and resolution.
May support start-up phase.
• Create and maintain appropriate documentation regarding
site management, monitoring visit findings and action plans by submitting
regular visit reports, generating follow-up letters and other required study
documentation.
• Build awareness of features and opportunities of study to
site.
• Collaborate and liaise with study team members for project
execution support as appropriate.
Candidate Profile
1. M.Pharmacy (Pharmacology)/ BHMS/ BAMS
2. Minimum 2 Years Experience
3. Fresher can also apply (6 month training will be given)
4. Mumbai Location
Additional Information
Experience : 0-3 years
Qualification : M. Pharmacy (Pharmacology), MBBS, BHMS, BAMS
Location : Mumbai
Industry Type : Pharma
End Date : 20th October, 2019
Salary: 120000-240000 per annum
Send your CV or Biodata at: mote.ravindra@mediclincr.com
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