Govt Job: Clinical Research Associate "A"

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.

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. 

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Career as Clinical Research Assistant "A"

The St. John's Research Institute (SJRI) is a part of the St John's National Academy of Health Sciences, which is run by the CBCI Society for Medical Education. From its inception, St. John's has set before it an ideal of excellence in academic courses as well as service to society as a result of which it has truly become holistic both in its outlook and in its approach to the problems of community health.
In 2000, the Academy decided that its commitment to excellence in research required the setting up of an Institute that was dedicated to the pursuit of research and capacity development in St. John's. This vision encompassed improvement of health of the community and patients through research and development of a Center for Excellence in medical research in India.

Post: Clinical Research Assistant - 14V-MC-JADY Project

Forward CV/Resume with cover letter to: immunology_clinical_trials@yahoo.co.in
or vineeta_shobha@yahoo.co.in and cc to hr@sjri.res.in

OR

Apply online

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Clinical Research Associate required at Apotek "A"

Job Description

Walk-In Drive for Clinical Research Associate; 15-Oct-16, Saturday at Apotex Research, Bangalore Campus.


Apotex Research Private Limited (ARPL) based at Bangalore is engaged in in the development, bio-clinical evaluation, manufacturing, and distribution of safe and efficacious generic pharmaceutical formulations for the global market .
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Inviting Applications for the position.


Interview Venue :- Apotex Research Private Limited, Plot No. 1&2, Bommasandra Industrial Area, 4th Phase, Jigani Link Road, Bangalore - 560099. Gate No. 1

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Sun Pharma Hiring For the Post Of Clinical Research Associate "A"

Job Description :

• Facilitate and coordinate with investigator and site for EC submission and approval.
• Conduct site feasibility and qualification visits.
• Get trained on trial and documents.
• Prepare for kickoff
• meetings to train vendor representatives involved if outsourced
  activity for monitoring.
• Coordinate with investigator and sites for IM and assist PM in planning for IM
• Conduct SIVs, write SIV reports, and dispatch to sites
• Resolve queries and problems at sites and with vendors.

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Sun Pharma hiring Clinical Research Associate "A"

Job Description

1. Facilitate and coordinate with investigator and site for EC submission and approval.
2. Conduct site feasibility and qualification visits.
3. Get trained on trial and documents.
4. Prepare for kickoff
5. meetings to train vendor representatives involved if outsourced
6. activity for monitoring.
7. Coordinate with investigator and sites for IM and assist PM in planning for IM
8. Conduct SIVs, write SIV reports, and dispatch to sites
9. Resolve queries and problems at sites and with vendors.
10. Monitor sites, write monitoring visit reports and send timely monitoring followup
11. letters to sites.
12. Obtain updated weekly trackers from sites
13. Report SUSARs to regulatory authorities and all SAEs to sites, ECs, and investigators.
14. Coordinate with data management team and investigator/site team for timely DCF resolution.

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Opening for Clinical Research Associate in PAREXEL "A"

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.

Post: Clinical Research Associate II

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Inventiv health hiring Sr. Drug Safety Physicians "A"

 Sr. Drug Safety Physicians

inVentiv International Pharma Services Pvt. Ltd

3 - 5 yrs

Hyderabad / Secunderabad , Pune

Job Description

Responsibilities
Medical review of adverse events reported to investigational and marketed products including identification of event/s, confirmation of seriousness, ensure that events are coded and mapped to the appropriate terms in MedDRA, provide assessment of expectedness per reference safety information, assessment of causality, review of narrative for chronology and medical content and provide medical evaluation comment.
Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment.
Ensure regulatory compliance with respect to the evaluation, reporting and surveillance of safety information.
Identify, communicate, and effectively manage potential safety issues.
Provide medical safety analysis and interpretation for periodic safety aggregate reports (e.g. DSUR, PSUR/PBRER, PADER, bridging reports, and other relevant aggregate report/analyses).
Interact with clients safety/medical personnel as appropriate to ensure above.
Maintain a working knowledge of projects in the functional area for which inVentiv Health Clinical safety is responsible for safety reporting.
Stay abreast of clinical and drug development information relevant to contracted programs by review of literature and by maintaining training.
Serve as a mentor for other internal safety staff including case processing staff.

Company Profile:

inVentiv International Pharma Services Pvt. Ltd

PharmaNet/i3 is recognized as a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. Our expertise includes therapeutically specialized capabilities for Phase I-IV clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team (FSP).

We seek individuals with a desire to excel in their fields, pursue excellence, and develop intelligent solutions by applying their knowledge and experience. Our employees focus on meeting our clients' requirements, work in a culture of mutual respect, and demonstrate a commitment to quality in everything they do. PharmaNet/i3 employees are empowered to think independently, be accountable, make decisions quickly, and use the resources of our global organization on our customers' behalf.

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