Clinical Development Services Agency (CDSA) mission is to create, develop, and nurture world-class clinical product development capacity in India.
Post: Study Monitor/Clinical Research Associate
Emoluments/ Duration: Rs. 46,000/- per month consolidated
Job Profile
The Monitor/ CRA conduct monitoring visits for assigned study’s protocol and study sites. Overall responsibilities are to ensure that the study is being conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
- Performs site monitoring throughout the trial which involves visiting the trial sites on a regular basis (site initiation to site closeout) in accordance with contracted scope of work
- Completes appropriate therapeutic, protocol and clinical research training to perform job duties.
- Setting up the trial sites such that each centre has the trial materials, including the trial drug while ensuring all trial supplies are accounted for.
- Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- Provide training and assistance to site staff.
- Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
- Manages the progress of assigned studies by tracking regulatory/ IEC submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution.
- Verifying that data entered on to the CRFs is consistent with patient clinical notes (source data/ document verification).
- Writing visit reports as per departmental Standard Operating Procedures.
- Filing and collating trial documentation and reports.
- Archiving study documentation and correspondence
- Evaluates the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Escalates quality issues to the project manager and/ or senior management.
- Work with Clinical Portfolio Management on other projects as directed and other internal departments on their requirements as and when required
Qualifications and Experience
1). Master’s degree in life sciences, pharmacy, healthcare or other related discipline or equivalent combination of education, training and experience or diploma/ post graduate degree in Clinical Research
2). MBBS/ BDS/ BHMS/ BAMS/ BPT preferred
3). At least with 3 years of relevant clinical monitoring experience in clinical trials
Find more info on Next Page...
Subscribe to Pharmatutor Job Alerts by Email
Skills
- Computer skills including proficiency in use of Microsoft Office applications .
- Basic knowledge and ability to apply GCP and applicable regulatory guidelines.
- Strong written and verbal communication skills including good command of English required.
- Excellent organizational and problem solving skills.
- Effective time management skills and ability to manage competing priorities.
- Ability to establish and maintain effective working re lationships with co - workers, managers, investigators
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 Program Director, CDSA, 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 “Study Monitor/ Clinical Research Associate (GLSE Study)” to cdsa_admin@thsti.res.in.
6. Only shortlisted candidates will be contacted for interview
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 the maximum and can be lesser based on candidate’s experience, qualifications, skill set, etc. A 10% annual increase in salary is based on the performance
9. This position is strictly project-based and co-terminus with the project.
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 for attending the interview.
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.
14. The last day of application is every Saturday of the week. If candidates are short-listed, they will be called for interview on the following Friday or other days based on the availability of interviewees.
Those who have applied earlier need not apply again.
Recruitment Notice No. CDS/RN-GLSE 07/2016
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)
See All B.Sc Alerts B.Pharm Alerts Mumbai Alerts
See All Other Jobs in our Database
.png)
