Clinical Research & Operations Mangement @ Gratisol Labs

Organization at a Glance:
Gratisol Labs is a leading resource consulting services organization for the Pharmaceutical, Biotechnology and Medical Device industries. We offer contract and permanent job opportunities within the Pharmaceutical, Biotechnology and Medical Device industries to both experienced professionals and entry level candidates.
The services offered fall into the broad categories of Recruitment Solutions, Temporary Staffing, Outsourcing, Consulting, Application Training in Clinical Data Management (Oracle Clinical, Oracle Inform/Central Designer), Pharmacovigilance (Oracle Argus Safety Database, Oracle AERS), CDISC SDTM & SAS to aspirants of Clinical Research Industry. We successfully help some of the top Pharmaceutical, Biotechnology and Medical Device organizations from around the world to recruit high caliber experienced & trained professionals.
The Pharmaceutical & Clinical Research Industry, worldwide is facing a huge shortage of trained manpower resources. With a View to fill this gap between the demand & supply of trained manpower and to help Pharmaceutical & Clinical Research industry to move on the fast track Gratisol Labs offers cutting-edge packaged and customized corporate training programs. In addition, Gratisol Labs has developed a tailored training division ‘Gratisol Academy of Clinical Research’ to provide Training, Internships, & Educational programmes that are designed to develop careers for clinical research professionals in Clinical Data Management, Pharmacovigilance & SAS.

We have the global capabilities and a flexible approach to meet our clients’ needs. Our operational excellence brings quality, efficiency and effectiveness to operational performance. The services offered fall into the broad categories of temporary staffing, permanent placement, outsourcing, consulting and outplacement. We successfully help some of the top scientific, clinical, biotechnology and pharmaceutical organizations from around the world to recruit high caliber experienced professionals.

Through our vast nationwide network and “talent sourcing” model we are able to rapidly respond to our clients with excellent results and personalized customer service, making us one of the most innovative and reliable healthcare staffing and search firms.

Gratisol Labs also provides Site Management Services, Clinical Data Management, Pharmacovigilance, Medical Writing, Biostatistical Analysis, SAS Programming & IT Support Services to Pharmaceutical, Biotechnology and Medical Device Organizations globally.
Gratisol Labs Advantages:
• 4 months internship available after training in Hospitals & CROs
• Own CRO live projects
• Highest Placement record across all training institutes
• Industry SOPs based training
• Trainers with minimum 5 years experience
• 24 hours access to application lab
The focus of the lectures will be mainly on the following topics:
This course focuses on the essential principles of Clinical Research and standard regulatory controls necessary to study the safety and efficacy of a drug. The course content has been reviewed and approved by Clinical research experts and academicians where more emphasis is laid on Planning, conducting, monitoring and generating information as per global standards and regulatory requirements. Students are not only trained in Clinical Research but there is a special focus given to Management & Soft Skill learning.

This course will provide training in the core competencies in clinical research including fundamentals of clinical trials. It's a great program for industry professionals who are looking to advance their careers or seeking industry certifications and anyone looking to enter the clinical research industry.

Clinical Research Industry Oriented Training Syllabus:
Certificate Course in Clinical Research

CLINICAL RESEARCH CONCEPTS, GUIDELINES AND REGULATIONS

• Introduction to Clinical Research.
• Pre-Clinical Research
• Drug Development Process
• Ethics In Clinical Research
• ICH-GCP Guidelines
• Schedule Y/NDA/ANDA
• FDA
• Phase I - IV, Post Marketing Surveillance
CLINICAL RESEARCH OPERATIONS

• Clinical Trial Design
• Protocol Design and Format
• Case Record Form
• Clinical Trial Supplies and Management
• Feasibility Studies
• Essential Documents and Trial Master File
• Archiving and Record Keeping
• Informed Consent
• Investigator Selection
• Investigators Meetings
• Roles and Responsibilities Of Players In Clinical Research(Sponsor, Investigator, Monitor, Stastician, Project Manager)
• Site Management
• Conduct Of A Study
• Pharmacovigilance
• Report Writing
• Publication
• Data Management
• Project Management
• Pharmacoepidemology
• BA/BE Studies
• Pharmaeconomics
• Central Laboratory
• Pharmacovigilance
• Outsourcing CR Projects
• Expanded Access Programs
• Patient Recruitments
• Audits And Inspections In CR
• Fraud And Misconduct In CR
• Communication Skills Required For Effective Monitoring.
• Liability And Indemnity In Clinical Research
Live Project Training with Internship will also be provided in Hospitals & CROs.
Mode of training- Instructor Led Class room/ Online Training

Our candidates employed in Mahindra Satyam, GSK, Quanticate, ICMR, Global Hospitals, Apollo Hospitals, NIMS, Quintiles, Novartis, Glenmark Pharmaceuticals Ltd, Parexel International (India) Pvt Ltd, AstraZeneca-UK and many more…

To reserve the seat immediately, send a DD of Rs.500/- in favour of Gratisol Labs payable at Hyderabad along with your resume by courier or registered post. You can also reserve the seat by doing cash payment at Gratisol Labs Premises.
Tenure: 2 month
Eligibility
Applicants are recommended to have one of the following life Science degrees: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospitals.
Certification
Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Gratisol Labs.
For more information, please contact Gratisol Labs at [email protected]
For More Details: Please Contact

Gratisol Labs
Academy of Clinical Research
13-14, Ayush Vihar, Sector-6
Near Dronacharya Academy
Jankipuram Vistar
Lucknow- 226001
Contact No:0522-4000785 , 0522- 4001459,
Cell No: 07800856806, 08009084154
E: mail: [email protected], [email protected]
Website: www.gratisol.com