Joby John

Mob: +971-*********

adgr0c@r.postjobfree.com

Profile Summary:

Professionally qualified medical research professional skilled in all aspect of Clinical Operations, Clinical Research and medical practice healthcare environment. Demonstrate strong working knowledge of ICH-GCP, Standard Operating procedures, Regulatory guidelines, protocol and monitoring guidelines, consistently perform at peak professionalism, adhering to code of ethics and business standards. Experienced to manage multiple areas including Nursing profile, Clinical Research Associate, Clinical Research Coordinator, Quality control, Clinical Auditing, Patient Coordination, Clinical Research Nurse, Report Reviewer etc. Having the ability to work in partnership with a range of organizations and can demonstrate initiative, qualitative high attention to detail.

Professional Experience

1. Medical Aid, at Al-Fardan properties Management, Dubai from 16-Jul-2019 to till date

2.Assistant Manager- Clinical Operation, Notrox Research Pvt.Ltd, a Clinical Research Organization at Salem, Tamil Nadu and Bangalore, India from 05-Apr-2017 to 13-Jun-2019

3.Senior Staff Nurse ( Nurse Auditor) with Aster CMI Hospital a unit of DM health care, Bangalore, India from 06-Jun-2016 to 12-Mar-2017

4.Senior Executive (Training & development) and Research Nurse Coordinator with Semler Research Centre a Clinical Research Organization, Bangalore, India from 08-Oct-2013 to 26 May-2016.

5.Clinical Research Nurse at Lotus Labs Pvt. Ltd, a Clinical Research Organization, Bangalore, India from 02-Jul-2007 to 12-Nov-2010

6.Staff Nurse at Sanjay Gandhi Accident Hospital and Research Institute, Bangalore, India from Feb-2006 to Jun-2007(As a Trainee Nurse from Nov-2005 to Jan 2006).

7.Consultant Clinical Auditor with IRIS Corporation from Apr-2018 to Jun-2019.

Training and Certifications:

Training program on ISO-QMS-9001:2015 /ISMS 27001:2013

Training program on International Conference of Harmonization in Good Clinical Practice (2007 to 2010,2013,2015&2017)

Training on Good Documentation Practice.

Advanced Cardiac Life Support and Basic Life Support (2011-13)

First Aid and Cardiac Pulmonary Resuscitation.

Fire fighting Training.

Phlebotomy Practice

Goals and Achievements

Received a formal appreciation from USFDA Inspector for conducting the Clinical study with global standard and quality.

Received formal appreciation form Sponsors, Auditors and from CRO for Excellent Clinical Documentation and reporting.

Attended and completed the Performance Qualification for CTMS- software for Clinical registration and management.

Participated Verification and audit of Hospital Information System.

Attended and completed Performance Qualification and Protocol development for SPECTRA-LMS – software for Training and development.

Career Summary:

Assistant Manager- Clinical Operation, Notrox Research Pvt.Ltd,

1.Solicit industry sponsored clinical trials at in-house clinical unit.

2.Review the protocol and proceed for IRB / IEC approval

3.Register the protocol with patients and study participants with appropriate statistical centre and BA centre.

4.Prepare or participate in quality assurance audits conducted by in-house, study sponsors, federal agencies, or specially designated review groups.

5.Participate in preparation and research budgets monetary disbursements.

6.Perform specific protocol procedures, ICD presentation etc.

7.Interpret protocol advice treating physicians on appropriate dosage modification.

8.Develop advertising other informational materials to be used in subject’s recruitments.

9.Interact with representatives for successful study completion.

10.Confer with the healthcare professionals to define the best clinical practice.

11.Track enrolment status of subjects and patients.

12.Record adverse event data confer with investigators regarding the reporting events.

13.Prepare study related documentation like protocol worksheet, Procedural Manual, Adverse event reports, IRB/ IEC documents and CSR reports.

14.Participate in the development of protocols including guidelines for administration or data collection procedures.

15.Order Investigational Product or devices necessary for study completion.

16.Maintain contact with sponsors to schedule coordinate site visits or to answer question about issues like incomplete data.

17.Instruct staff in scientific procedural aspects of studies including standard of care, Informed consent procedures, or documentation procedures.

18.Identify protocol problems and assist Investigator for protocol revision or amendment.

19.Direct the requisition, collection, labelling, storage, or shipment of specimens.

20.Communicate with Laboratories or Investigators regarding laboratory findings.

21.Assist Investigator to prepare presentations or reports of clinical study procedures, results and conclusions.

22.Monitor the entire study activities to make sure compliance with protocols and with all relevant local, federal and regulatory institutional policies.

23. Maintain required records of study activity including case report forms, all related CRF’s.

Senior Executive (Training & development) and Nurse Coordinator at Clinical department with Semler Research Centre from 08-Oct-2013 to 26 May-2016

1.Primary data collection from patients and clinical study participants.

2.Participate and monitor Blood sample collection, IV cannula insertion, Vital signs monitoring, Sample transfer to diagnostic lab etc.

3.Ensure the Clinical Trail conducting in accordance with GCP, in-house SOPs and applicable guide lines.

4.Time management with Clinical projects.

5.Monitor the ICU and Ambulance are equipped for all the time. Monitor the study activities; arrange the staff for study related activities.

6.Ensure the safety and wellbeing are protected for the clinical study Participants.

7.Management of AE and resolution, AE follow-up.

8.Monitor the Sample Processing, Sample Segregation, Sample Separation etc...

9.Initiate Protocol and SOP training for clinical staff.

10.Guide and assist the new employees on Induction and orientation.

11.Provide in house training and On-the job training for new employees.

12.Develop training method, training Calendar for in-house staff and for different departments.

13.Ensure all the clinical staff are enough competent to perform the delegated activities.

Consultant Auditor with IRIS Corporation from Apr-2018.

1.Providing external audit support for Clinical aspects( CRO’s, Diagnostics Lab’s, Hospital Training Institutes, etc)

2.Providing On site verification activity, Performance Monitoring activity, Document verification.

3.Invigilate the process and providing a complete audit report with compliance, Correction, and recommendation to improve the quality in system and functions.

Senior Staff Nurse (Nurse Auditor) with Aster CMI Hospital

1.Interact with the patients regarding the service and procedures.

2.Ensure the Patient safety and satisfaction on all procedures.

3.Ensure the IPSG goals are followed and maintained.

4.Guide the staff to aware about the NABH requirements.

5.Ensure the safe and correct practices are followed for the Medication administration.

6.Conduct quality improve learning program for staff.

7.Ensure all the Nursing activities taken place as per the procedure manual

8.In vitro and vivo audits, HIS documentation verification.

Clinical Research Nurse at Lotus Labs Pvt. Ltd,

1.Conduct Clinical Trial Study in Human Adult & Patients with the all requirements.

2.Perform Investigational Product Administration

3.Perform Sample collection, Sample Separation, Sample Segregation.

4.Perform Vital Signs and safety evaluations.

5.Perform Screening and enrolment of Volunteers.

6.Maintenance of ICU and Ambulance medication and documents.

7.Ensure all the clinical activities conducted as per the in-house SOP and guide lines.

Staff Nurse at Sanjay Gandhi Accident Hospital and Research Institute from Feb-2006 to Jun-2007(As a Trainee Nurse from Nov-2005 to Jan 2006).

1.Scheduled patient admissions and discharges

2.Assess patient status and notify physicians of clinical changes

3.Interact with departments regarding patient care

4.Educate patients/families on health care needs, conditions, options, etc.

5.Maintained patient's charts and confidential files.

6.Quickly and accurately assess patient care needs.

7.Work collaboratively with doctors and staff to provide exceptional care

8.Perform all requested diagnostic tests

9.Diagnose and develop treatment plans collaboratively with doctors and staff

10.Manage multiple cases simultaneously, prioritizing needs continually

11.Comply with all legal and safety requirements at all times

12.Maintain a clean, sanitary, and organized work environment

13.Work at maximum efficiency without compromising quality of care

14.Abide by all hospital rules and regulations

15.Act in a composed and professional manner, especially under pressure

16.Monitor co-workers and voice concerns to minimize errors

17.Provide follow up care instructions to patients and make necessary referrals

18.Maintain accurate and up-to-date patient charts

19.Attend all required training and continuing education events

Audit Faced

DCGI / USFDA /WHO / MOH-Turkey/ Regulatory Audits / NABH /NABL

Educational Background

1.Master of Business Administration-Hospital Management- GITAM University

2.Bachelor of Science(Post basic) in Nursing-from Rajiv Gandhi University

3.Diploma in General Nursing.

Personal Details

Gender-Male

DOB- 31-05-1985

Holding Indian Passport

Skype: id- joby.john4

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