Personal Summary
As an experienced clinical research associate, my tenacious and proactive approach
resulted in several successful clinical trial conduction. With overall 7 years of clinical research experience I am looking forward to exploring more in terms of knowledge and experience into clinical research industry and aiming to leverage my skills to successfully fill the role at your company.
Areas of expertise
• Clinical Trial Management
• Site Management
• Clinical Data Management
• Regulatory liaising
• Site Monitoring (PSV, SIV, SMV, SCV)
• Site Start up Activities
• Investigators Selection
• Vendor Management
Experience of therapeutic indications
• Oncology
• Vaccine
• Dermatology
• Gastroenterology
• Gynaecology
Professional experience
Sr. Clinical Research Associate
Innovate Research Pvt. Ltd., Noida, U.P/ May 2019 – Feb 2020 Duties:
• Ensured that project management activities were conducted as per the plan and the Standard Operating Procedures (SOPs)
• Finalization of study related documents in consultation with sponsor and relevant study team members.
• Site feasibilities and Site Qualification visit.
• Finalization of study budget, contracts and Clinical trial agreements.
• Supervising activities of the CRAs
• Ensure study timelines are met with quality data
• Facilitation of EC submission, coordination with, preparing pre study documentation, Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), coordination for safety reporting from site through Medical Monitor, Clinical Trial Material accountability (CTMA), tracking of completed electronic case report forms
(eCRF), Compliance with protocol and Good Clinical Practices, maintenance and archival of Trial Master File (TMF)
• Prepared Study protocols, CRF, ICF and other study related documents.
• Notified the project team of enrolment updates, monitoring status, eCRF entry, etc
• Participated in Study related regularly scheduled teleconferences with the clinical project team.
SHAILJA CHANDEL
Sr. Clinical Research Associate
Contact Information
Chandel Niwas, Thakur
Colony, Sanjauli, Shimla,
Himachal Pradesh- 171006
addg08@r.postjobfree.com
Personal Information
DOB 13-Apr-1991
Marital Status- Married
Language known- English
and Hindi
Nationality – Indian
Clinical Research Associate II
PPD, Gurgaon Haryana/ August 2018 – April 2019
Duties:
• Performed - PSSV, IMV, SCV for trials assigned.
• Implemented and monitored clinical trials to ensure sponsor and investigator obligations are being met and compliant with applicable local regulatory requirements and ICH guidelines.
• Performed source document verification, retrieves case report forms (CRFs) and performed query resolution in a timely manner and oversees drug accountability and safety at investigative sites.
• Ensured Serious Adverse Event (SAE) reporting according to project specifications, reviewed SAE information, resolved queries and assisted sites in completion of SAE reports.
• Performed investigator site file reconciliation, requested any new or updated site- related essential and non-essential documents and reviewed them for content, consistency with other documents and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.
• Generated reports for site and project management using CTMS.
• Assisted in final closure of study.
Clinical Research Associate I and II
Innovate Research Pvt. Ltd., Noida, U.P/ May 2014- July 2018 Duties:
• Responsible for the management of designated clinical trials including investigator selection, analysis of potential patient recruitment, preparation of trial related documentation (protocols, Case report forms, consent documents, letters of agreement, confidentiality agreements), organising Ethics committee submissions with follow through to ensure successful outcome.
• Monitored the assigned clinical trial following company SOPs and in accordance with GCP. Participate in conference calls and meetings to review progress of ongoing clinical trials.
• CTRI registration of trials.
• Maintained project files with documents including: ethics committee approvals; curricula vitae of investigators, study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start- up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.
• Reviewed essential/regulatory documents, ensuring Investigator Site Files (ISF) are accurate and current
• Conducted un-blinded drug accountability visits, reviewed drug inventory and subject accountability records, inspected the storage area for study medication Personal Skills
• Patience & self-discipline.
• Easily adaptable to any
working conditions &
ability to work well under
pressure
• Time management
SKILLS
CTMS
EDC
MS
Office
ICH
GCP
Fast
Learner
Effective
Communi
cation
Clinical Research Coordinator
Fortis CRO- PI Dr. Rohit Batra- New Delhi / Feb 2013– Feb 2014 Duties:
• Assisted Principal Investigator in patient selection and conducting the clinical research study.
• Documentation of enrolment of patients, follow up logs, drug accountability logs, case report forms, subject’s evaluation forms etc.
• Resolved data queries
• Coordinated with sponsor monitors during monitoring visits
• Coordinated with the sponsor at Site close out
Education
PGD In Clinical Research & Clinical Data Management, 2012 Cliniminds B.Sc. (Hons.) Biotechnology 2009-12 HPU
References
References available upon request