JOBY JOHN E Mail: firstname.lastname@example.org
Experienced in Health care industry with Clinical Operations, CRO Operations (BA/BE projects and Clinical Trial), Senior Executive ( Training & development), Clinical Research Coordinator, Quality Control-Clinical, Project handling -Clinical Trial Projects, Client relation,Patient Coordination, Clinical Auditor, Clinical Research Nurse and Staff Nurse positions.
Assistant Manager -Clinical Operations for Health care Organisation and experienced Patient Data collection, Patient Enrolment, Clinical operations including Staff management, Patient management, Study participants Management, Project allocation and management, CSR review, Client Communication& Customer management, IEC/ IRB coordination, AE update and resolution, Diagnostic Sample Management, Patient follow-up, Internal audit
Maintain employee daily report, Client & Visitor Management, Vendor Management for materials, Management of Housekeeping service and Security services, Travel arrangement (If required), Inventory management.
Senior Executive (Training & Development) and Clinical Research Nurse Coordinator:
Act as SME for Clinical department, provide induction and orientation for new joinees, Communicate to each department for SOP implementation and for revision, ensure all the SOP’s are revised and trained by individuals, Allocate staff for On the Job training and monitor the activities. Provide SOP training and arrange external training.
Nurse Coordinator: To ensure all the Clinical Trial conducted as per ICH-GCP guidelines, Protocol and as per In-house SOP, Collection of Patient Data, Patient enrolment for clinical projects, ICU and Ambulance management, Staff Management, Control of Clinical Process Unit, Clinical Research Associates & QC activities, Maintain time management for projects, Collection of Pathological samples, Shipment of samples to the Diagnostic service and to Analytical Lab, Management of AE and resolution, Assurance o accuracy and integrity of Clinical data was protected, Safety and wellbeing of Patients and Clinical study Participants.
Clinical Auditor (Senior Staff Nurse)- :
Associated as an Auditor in the clinical and the Patient side, mainly focused in nursing department to ensure the safety and wellbeing of patients and quality of treatment are delivered to the patient by the nursing team. Verify the IPSG standard, JCI guidelines, NABH requirements are followed for all procedure. Collect the data of patient, HIS verification and details collection, Monitor the clinical activities and guidance, Verification of MOM, Presentation of Quality Improvement program, CAPA, Monthly Presentation of Quality Improvement, Protection of IPSG goals promotion of quality in activity. Verification of Admission and discharge procedures.
Consultant Auditor (for Clinical):
Worked as a Consultant Auditor for Clinical aspects and providing support for external facility audits, In-house Clinical audits, On site audit verification to ensure the compliance and the quality requirements.
1.Assistant Manager- Clinical Operation, Notrox Research Pvt.Ltd, a Healthcare Clinical Research Organisation from 05-Apr-2017 to 13-Jun-2019.
2.Senior Executive and Nurse Coordinator at Clinical department with Semler Research Centre from 08-Oct-2013 to 26 May-2016.
3.Consultant Auditor with IRIS Corporation from Apr-2018.
4.Clinical Auditor ( Nurse Auditor) with Aster CMI Hospital from 06-Jun-2016 to 12-Mar-2017
5.Clinical Research Nurse at Lotus Labs Pvt. Ltd, from 02-Jul-2007 to 12-Nov-2010
6.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).
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.
ACLS and BLS( 2011-13)
First Aid and Cardiac Pulmonary Resuscitation.
Fire fighting Training.
Goals and Achievements
Attended the USFDA- audit for Clinical study with the FDA inspector and completed successfully.
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 needs and updates.
DCGI / USFDA /WHO / MOH-Turkey/ Regulatory Audits / NABH /NABL
MBA in Hospital Management- GITAM University
Bachelor of Science in Nursing-from Rajiv Gandhi University
Diploma in General Nursing
Holding Indian Passport
Skype: id- joby.john4