ACADEMIC QUALIFICATIONS:

2009 M. Sc. (Clinical Research)/ Institute of Clinical Research (India) / Cranfield University

2007 Post Graduate Diploma in Pharmaceutical Management/Institute of Clinical Research (India)

2005 Bachelor of Pharmacy/ University Dept. of Pharmaceutical Sciences / Nagpur University


CURRENT POSITION:


Organization
CliniRx Research Pvt. Ltd.

Designation
Clinical Research Associate-II

Tenure
7th Sep, 2009 – till date


Key Responsibility

•Participates in study feasibility activities and report the outcome to the appropriate manager
•Identify and qualify potential investigators to ensure that the sites have adequate time and can fulfill their obligation to the study.
•Actively participates in the planning and conduct of investigator meetings and attends the meetings when required.
•Actively involved with the study-start up activities
•Initiate investigational sites to ensure that the site personnel have a good understanding of the protocol and that they understand their obligations to conduct a clinical trial as required by applicable regulations.
•Ensure that the site receives the investigational product and the requirements of the study and that they can fulfill their obligations to conduct the study accurately and to meet the deadlines.
•Track the flow of regulatory documents for the projects responsible for, in order to co-ordinate and deliver the appropriate documents to meet regulatory and ethics committee submission dates.
•Address any site issues concerning protocol non-compliance with the principal investigator.
•Provide ongoing training to the site personnel with regards to ICH-GCP guidelines and CliniRx SOPs to ensure the quality and integrity of the data.
•Ensure the effective and timely co-ordination of the supply (and subsequent disposal) of clinical materials to the site to ensure that the site can start to actively recruit patients as soon as ethical approval at the site is available.
•Develops patient enrollment strategies with the project team and study sites
•Collaborate with the Team lead to ensure that the principal investigator complies with the serious adverse event reporting requirements as defined by both the client and regulatory bodies within the specified time periods.
•Perform site visits to ensure that the site personnel are conducting the study in accordance with the protocol and ensure that any issues arising from the visit are documented in a visit report and addressed with the site in a timely manner. Any concerns or ongoing issues to be escalated to the Team Lead.
•Ensure proper storage, dispensation, and accountability of Investigational product and trial-related materials
•Prepare and submit visit reports in a timely manner.
•Actively coordinating with the sites to resolve the DCFs in a specified timeline
•Interact with investigators to obtain necessary documentation and information before, during and after the study.
•Ensure accurate inventory of central, investigator site and core files on an ongoing basis to ensure that the files are complete.
•Function as mentor and role model for other CRA team members to ensure study specific training for CRAs and that the sites are effectively managed.
•Perform co-monitoring visits with CRAs or at the sites, as required, to identify the problems and possible areas for training and address these with the Team lead manager where applicable.
•Maintain project tracking system (ex: MV tracker/Safety Report Tracker) on an ongoing basis to ensure that progress regarding the sites can be tracked. Provide status updates to the Team Lead.
•Assist with the audit of an investigational site or central files and liaise with Quality Assurance personnel as required to ensure that the study is being conducted in accordance with ICH GCP guidelines.
•Works closely with the Team lead and Line Manager where appropriate to reply and resolve audit Query/report in a specified time
•Manage and track the investigator grants with study sites when required.
•Completes study site close-out visits
•Complete routine administrative tasks in a timely manner (e. g. OMEGA/ timesheets/travel expense claims).
Attend study meetings and training sessions as required.

Experience:

III - Parkinson’s Disease



III - Low Back Pain

•Site Monitoring Visits
•IP & other CTS tracking and reconciliation
•SMF maintenance
•Site follow ups and Management
•Maintaining in house documentation and TMF maintenance
•Site Closeouts


PREVIOUS RELEVANT POSITION(S) AND EXPERIENCE:


Organization:
SIRO Clinpharm Pvt. Ltd.

Designation:
Clinical Research Associate

Tenure:
JUL, 2008 – Sep, 009


Key Responsibility

•Clinical Study Document (i. e. Protocol, Informed Consent Form, CRFs) Review
•Conduct Site Qualification Visits
•Regulatory/Ethics submissions
•Organize and coordinate Investigators’ meeting
•Conduct Site Initiation Visits
•Perform Site Monitoring Visits
•Perform close-out visits
•Maintain regular phone contact with the sites
•Assess the site organization on regular basis in order to secure the quality and support the site
•Day to day communication with central or local laboratories, and other providers/vendors (if any)
•Study filing: prepare and send all critical documents and translations as per project requirements
•Liaise with central laboratory on project management/protocol issues
•Participate in internal team meetings
•File/archive Project documents
•Maintain regulatory documents/Trial Master Files
•Perform in house follow-up of issues with the sites
•Reconciliation and Management of clinical trial supplies

Experience

III - Tenia Pedis

III - Psoriasis


•Site Initiation Visit
•Site Monitoring Visit
•IP & other CTS tracking and reconciliation
•SMF maintenance
•Site follow ups and Management
•Maintaining in house documentation and TMF maintenance


Organization:
PPD Pharmaceutical Development *****

Designation:
Trainee Clinical Research Associate

Tenure:
MAR, 2008 – JUN, 2008

Experience:

III b Diabetes

•Rigorous training activities attended and performed as per Trainee-CRA Programme.
•Performed Observational Monitoring visits and Telephonic SIV for the assigned projects.
•Supported clinical teams in project administration and preparation from trial set up, monitoring, tracking and close out.
•Maintained project files and documentation in an orderly manner according to the relevant SOPs and WPDs.
•Supported the preparation of Regulatory packages as assigned.
•Supported the preparation of Ethics Committee Submission packages as assigned.
•Provided general administrative support to project team members, and ensuring that project related administrative tasks are carried out in a timely manner as ***** anization:
Nicholas Piramal India Ltd.

Designation:
Trainee Executive-Production/QA

Tenure:
Aug, 2005 – Jun, 2006


Key Responsibility

•Worked in project team at Baddi plant.
•Coordinated in all construction and machinery installation activities.
•Engaged in all qualification and validation activities.
•Supervised all production activities in tablet and capsule department as per cGMP.
•Maintained cGMP documentation.
•Training and Development of subordinates.

TRAINING:

JUL-2007 to AUG-2007:
Assisted as a Clinical Research Co-ordinator at Avanti Institute of Cardiology, Nagpur- India.
Therapeutic area: Cardiology

JUL-2007 to JUL-2007:
Participated in “MANAGE” study (MANaging unstable AnGina Effectively). The study was about practice pattern in unstable angina/NSTEMI in secondary and tertiary health care setup in and around Nagpur (central India) the study was conducted in Wockhardt Heart Hospital, Nagpur- India.

NOV 2007:
Attended 40th Annual Conference of Indian Pharmacological Society at NIPER, Mohali - India

FEB 2008:
Attended workshop on ICH-GCP at Smt. C. H. M College, Mumbai - India


AFFILIATIONS:

Member of Maharashtra State Pharmacy Council as a Registered Pharmacist