Clinical Development Services Agency (CDSA) mission is to create, develop, and nurture world-class clinical product development capacity in India.
Post: Research Officer (Medical), Verapamil Study
Emoluments/ Duration: (up to Rs. 53,000 per month, consolidated) for 04 months
Job Profile
• Managing all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring compliance with GCP and applicable guidance.
• Providing input into and/or developing study related materials such as Clinical operations plan, Data Management Plan and CRF completion guidelines, informed consent, site instructions for specimen collections, study logs/forms and study related documents
• Coordinating with sites for site assessment, IEC submissions/approvals and site initiation.
• Performing site monitoring visits for the clinical as well as bioanalytical aspects as per study requirements
• Reviewing protocol deviations and data listings to ensure quality data are delivered;
• Preparing site visit reports and escalates issues to the relevant stakeholders.
• Communicating with study site staff and investigator for tracking patient recruitment and progress to study timelines; supporting safety reporting and IEC submissions; maintaining and reporting metrics for clinical site performance
• Facilitating site study drug orders, and ensuring site accountability records are maintained
• Maintain study master files to ensure their compliance with required regulatory and GCP quality standards and consistency with CDSA SOPs.
• Providing input and support to maintain appropriate documentation for adverse event safety monitoring, and collaborating in submission of safety reports to DCGI, and other applicable authorities
• Providing support to site team to prepare for clinical audits and to respond to audit findings conducted by internal QA and external agencies
• Work with coordinating PI to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding, or timelines
• Organising project meetings as per requirement
• Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
Qualifications and Experience
MBBS/ BDS/ MPH/ PhD with 3-4 years of clinical project management and/or Clinical Operations experience in clinical/public health / research projects.
Skills
• Ability to gain trust and confidence with stakeholders.
• Operational skills including focus and commitment to quality management and problem solving
• Influencing skills including negotiation and teamwork
•Effective communication skills, the provision of timely and accurate information to stakeholders
• Ability to develop and implement clinical research monitoring plans, SOPs, database concepts, and formats
• Understanding of GCP, regulations and guidelines
• Excellent Computer skills (MS Word, excel, internet)
•Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards
• Knowledge of pharmacokinetic parameters and experience in conducting monitoring of bioanalytical laboratory including HPLC, LCMS techniques.
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GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be from a recognized Board/ University and full-time.
2. The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
3. Persons working in Govt. or Public Sector undertaking should produce "No Objection Certificate" at the time of Interview.
4. The qualification, experience and other requirements for the post can be relaxed at the discretion of the controlling authority, in case candidates are otherwise well qualified.
5. Interested candidates may please send their current CV with a recent photo and cover letter indicating their motivation for the position applied for (150 words) and three references along with the attached datasheet and excel sheet posted in the website. E-mail should be submitted with subject line Application for the post of "Research Officer - Medical (Verapamil Study)" to cdsa admin@thsti.res.in.
6. Only shortlisted candidates will be contacted for further discussion
7. Incomplete applications will stand summarily rejected without assigning any
reasons.
8. The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is an actual and will be based on experience, qualifications, skill set, etc. of the candidates.
9. This position is strictly project-based and hired only for 04 months.
10.All results will be published on our website and all future communications will be only through email
11. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement.
12. This position will be placed in CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
13. Canvassing in any form will be a disqualification.
Those who have applied earlier need not apply again.
Recruitment Notice No. CDS/RN/03/2016
CLINICAL DEVELOPMENT SERVICES AGENCY
An extra mural unit of THSTI,
An autonomous organization of Department of Biotechnology
Ministry of Science & Technology, Govt. of India
3rd Floor, THSTI Building, 3rd Milestone, Gurgaon-Faridabad Expressway,
Faridabad – 121001 (Haryana)
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