Name: Bhaskar S. Gajjala

Address: Mamata Estate, 5th Floor,

Room no 407, Allwyn colony, Miyapur,

Hyderabad - 500049. Mobile: +91-950*******

v904h3@r.postjobfree.com

v904h3@r.postjobfree.com

To produce outstanding results for my organization by applying my knowledge, professional skills in the field of Clinical Research & Pharmaceutical Sciences to the best of my ability.

AXIS CLINICALS LTD, Clinical Research Department, September – 2010 to till date.

Designation: Clinical Research Associate - II

Perform site selection, initiation, monitoring and close-out visits in accordance with protocol, standard operating procedures, good clinical practice and applicable regulatory requirements.

Clinical Monitoring Activities:

Have an experience in Psychiatry, Nephrology and Oncology

Ensure that the site personnel are adhering to the protocol and address any issues concerning protocol non-compliance with the principal investigator

Provide ongoing training to the site personnel with regards to applicable guidelines and AXIS 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 has been granted

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.

Collaborate with other departments (e.g. Medical / Pharmacovigilance, Regulatory) to ensure that the Principal Investigator complies with the serious adverse event reporting requirements as defined by both the client and regulatory authorities within the specified time periods

Prepare and submit visit reports in a timely manner (Per AXIS SOPs or contract as appropriate)

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, meet quality requirements and can be used as a source of reference

Perform ongoing on site data management / collection to ensure that issues relating to the quality of the data are communicated to the site personnel early and maintain close contact with Data Management.

Maintain project tracking system on an ongoing basis to ensure that progress regarding the sites can be tracked. Provide status updates to the Project Manager, CL and client as required

Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)

Build and maintain good and effective relationships with sites

Miscellaneous:

Site Feasibility: Contacts potential investigators to discusses the study details providing critical information needed to obtain the desired feedback to assess the feasibility of the proposed study

Site Management Activities: Prepare and submit or support those involved in regulatory and ethics committee submissions to ensure that documents are collected in a timely manner in order to meet regulatory and ethics committee / IRB submission dates

Attend staff meetings and training sessions as required to complete the training curriculum in a timely manner

Assist with the audit of a 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.

Ensure the timely and accurate investigator payments

Wockhardt Ltd., CPB Department. June - 2008 to September – 2010.

Designation: Clinical Research Associate

Clinical Research Associate for outsourced BA/BE Studies. (US FDA and European submission)

Have an experience in Psychiatry, Nephrology, Gastroenterology, Orthopedic, Neurology and Urology.

Assisted in preparation of protocol and Inform consent forms.

Assisted in obtaining Drug controller General of India (DCGI) approval for conduct of BA/BE studies on new drugs.

Administration of Investigational products to subjects.

Adverse events monitoring and reporting.

Preparation of Case Records Forms.

Compilation and Checking of Case Records Forms (CRFs), Consent forms & other Project Related Forms.

Conducted Informed Consent Process in the trial.

Participated in various others project related activities (i.e., check-in, check-out, custodian, sample processing, separation, storage and segregation etc).

Responsible to check for all the activities when subjects are inside the CPU.

Responsible for timely submission of compiled and completed clinical data to Data management cell.

Intradepartmental co-ordination (Bioanalytical, Biostatician, Data management cell and QA) during conduct of the study.

Monitored the study conduct and required essential documentation.

Monitored outsourced BA/BE studies conduct at various levels and required documentation including correspondence as a Sponsor’s Representative. (Monitored at Various CRO”s across India).

Ensure that the research site personnel including the investigators are conducting the study according to the clinical protocol, "Good Clinical Practices," and regulatory requirements.

Liaise with Pathology Laboratory, for timely supply of blood samples and provision of reports in timely manner.

Write and revise Standard Operating Procedures (SOPs) for relevant clinical section as per need and maintain awareness of all current SOPs.

Address to overall volunteer management during screening, study and post study follow-up. Daily and weekly planning and manpower handling.

CIPLA Ltd, Manufacturing & Research Division, Sep 2006 – June 2008

Designation: As an Analyst in Pharma R&D.

Zetasizer Nano ZS, Nanophox, Mastersizer 2000 Particle Analyzer’s

High Pressure Homogenizer

Rotavapour, Micrometer

Dissolved-Oxygen Meter

PG Diploma in Clinical Research from Smt. C. H. M. College, Ulhasnagar. Thane. {2007}.

B.Sc (Chemistry) – March 2006, D.G Ruparel College, Matunga Mumbai Board.

H.S.C - March 2003, A.E.S Jr.College, Wadala, Mumbai Board.

S.S.C - March 2001, B.P.P.M High School, Parel, Mumbai Board.

Successfully completed the NIH web based training course ‘Protecting Human Research Participants in 2011’

Successfully attended training on ‘Team Building Workshop’ during the Clinical Research Course - Mumbai. 2007

Submitted a Project to Smt. C. H. M. College Titled “Financial Disclosure in Clinical Research” during the Clinical Research Course.

With the clinical team of Wockhardt successfully completed and submitted around 30 outsourced pivotal Bioequivalence / Bioavailability /Pharmacokinetics studies to US FDA, and European regulatory bodies.

Played Superuser role in implementation of Volunteer management software solution (VMSS) at Wockhardt.

Successfully handled audit conducted by US FDA and other business clients in Wockhardt Ltd., CPB Department.

Excellent interpersonal, site management and relationship building, verbal and written communication skills including presentation skills

Team player with outstanding negotiation and organizational skills

Client focused approach to work

A flexible attitude with respect to work assignments, new learning and travel (overnight, weekend and occasional international travel may be required)

Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

Willingness to work with multiple supervisors/colleagues in a matrix environment, and to value the importance of team work

IT literate (experience with Microsoft based applications and general knowledge of PC functions

Father’s Name : Mr Sudarshan R. Gajjala

Date of Birth : 02nd April 1986

Gender : Male

Marital Status : Single

Nationality : Indian

Languages Known : English , Hindi , Marathi & Telugu

Hobbies : Playing Chess, Volley Ball , Cricket,

& Traveling.

I hereby declare that the information furnished above is true and no related information is concealed. If any discrepancy is observed at any stage, the authority is free to cancel my candidature.

BHASKAR .S. GAJJALA

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