C. P. Neelima Nambiar

Phone: +1-929-***-**** (M)

E-mail: ac2ctb@r.postjobfree.com

Summary

Clinical research professional with experience in clinical trial coordination and managing clinical trials. Proven ability to successfully manage multiple projects with short timelines. To work in a dynamic organization which provides not only a congenial work environment but also the challenges to hone my skills and bring out the best in me.

Professional Experience

-Clinical Research Assistant - Vasta Global, Mumbai, India. (March 2016 to Sept 2016)

Responsible for the management of designated clinical trials, preparation of trial related documentation per protocol and Case report forms (CRF).

Ensure completeness and submission of data into the data collection form as per protocol requirements and time lines.

Query resolution in a timely fashion and in compliance with ICH-GCP guidelines.

Ensure the conduct of the trial is in compliance with the currently approved protocol /amendment.

To significantly improve quality assurance and consistency in electronic data capturing and data.

Participate in global conference calls and meetings to review progress of ongoing clinical trial.

Protocol monitoring activities.

Communicate any observations to the sponsor i.e. deviations/violations to protocol, safety alerts, Quality issues, etc. that may affect the quality of the protocol.

Complete regulatory requirements, as applicable.

-Junior Data Analyst - Cognizant Technology Solutions, Mumbai, India. (Feb 2014 to Dec 2015)

Implement and promote the use of consistent, efficient quality processes to meet timelines and deliverables for the project teams

Review and action queries on an ongoing basis and update database appropriately.

Perform UAT according to Validation Plan for applicable Data Management systems.

Review reports and take actions as defined in the DMP or eCRF review manual

Provide listings for review to study teams as defined in the DMP and process discrepancies appropriately.

Perform ongoing and final consistency checks, review protocol deviation and data listings as defined in the DMP and eCRF Review Manual.

Perform updates post database lock if any.

Ensure that all Data Management activities are conducted in compliance with relevant regulatory requirements.

-Clinical research coordinator - Department of Endocrinology KEM Hospital, Mumbai, India. (Feb 2010 to Jan 2014)

Conducting feasibility related procedures.

Performing protocol visits.

Maintaining source documents of the subjects.

Study drug dispensing and accountability.

Completion of the e-CRFs.

Resolving Site DCFs and e-CRF queries.

SAE notification to Sponsor, Ethics Committee& Regulatory authority.

Keeping records of drug temperature.

Blood sample shipment preparation.

Maintaining correspondence with sponsor & Ethics committee.

-Scientific Officer - Ethics Committee for Research on Human subjects of Seth GS Medical College and KEM Hospital, Mumbai, India and Clinical research trainee (temporary basis) with the Member Secretary of the Committee for Academic Research Ethics (CARE) of Seth GS Medical College and KEM Hospital, Mumbai, India. (Dec 2008 to Jan 2010)

Arranging the Ethics Committee meetings: preparing the agenda, minutes of the meeting.

Receiving all research proposals.

Reviewing project related correspondence submitted by the investigators to the ethics committee.

Preparing letters to the investigators.

Monitoring visits at the investigator sites.

Creating & Revising Standard Operating Procedures for CARE and ECRHS.

Establishing Database and maintenance of records.

Part of SAE (Serious Adverse Event) Subcommittee which analyses the safety of the participant.

Retention and safekeeping of all records and documentation.

Communication with the Investigators.

ACADEMIA

Post Graduate Diploma Course in Clinical Research from St. Xavier’s College, Mumbai, India securing Grade: B+

Completed Masters in Science specializing in Animal Physiology & Biotechnology from Ramnarain Ruia College, Mumbai University, India securing Second class- 55.20% [2008]

Completed Bachelors in Science (Zoology) from Ramnarain Ruia College, Mumbai University, India securing First class- 69.62% [2006]

DIPLOMA PROJECTS

Project on SIDCER(The Strategic Initiative for Developing Capacity in Ethical Review)

Worked on development of a Protocol and Informed Consent Document.

Have gone for 2 mock monitoring visits.

PERSONAL DETAILS

Date of Birth : October 21, 1985.

Residential Address : 8414, 4th Avenue, Apartment A6, Brooklyn, New York. 11209.

C. P. NEELIMA NAMBIAR

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