Chintan Chandak
Rego Park, NY 11374
Email:**************@*****.***
Objective:
. Seeking an opportunity to pursue a career as an In House Clinical
Research Associate that provides an opportunity to achieve growth for
self and organization.
SUMMARY OF QUALIFICATIONS:
. Experience and knowledge of Clinical Trial process and involved in
Phase II and III Clinical trials of CNS, CVS, Oncology, Pain and
Asthma.
. Accountable for ensuring that site meet the performance expectations
with regards to recruitment, randomization and retention.
. Analyze and evaluate clinical data, to ensure investigator and site
compliance with the study drug protocol, overall clinical objectives,
and FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and
HIPAA.
. Maintain close contact with clinical trial site personnel and was
involved in site set-up, coordination and problem solving during the
conduct of a clinical trial.
. Review Study Protocol and was involved with site Coordinators and
investigators and Field clinical staff in collecting routine data.
. Prepare and process regulatory documents such as FDA forms 1571, 1572,
Investigator's CVs, Informed Consents, IRB Approvals, Investigators
Brochures, Case Report Forms, and Serious Adverse Event Tracking.
. Provide centralized site support, communication and coordination to
assure accurate and timely completion of all contracted activities.
. Write and submit timely and accurate regulatory reports, site
reference reports and study correspondence/documentation.
. Work with in the study team to identify study-related problems and
issues to meet objective and prioritize importance based on project
and business goals.
Professional Experience:
Clinical Research Associate
December 2007 till date
Ariad Pharmaceuticals, Inc
Cambridge MA.
. Therapeutic Areas include Phase II Oncology studies of endometrial
cancer .
. The primary objective is to assess the efficacy of ridaforolimus in
patients with recurrent or persistent endometrial cancer.
Job Responsibilities:
. Examine the pharmacokinetic characteristic and efficacy of
ridaforolimus in patients.
. Develop and implement independently corrective and preventive actions
at sites and provide continuous compliance and oversight.
. Coordinating the approval process for the performance of clinical
studies to IRBs and authorities with regard to the study site.
. Assist with development of clinical trial specific documents such as
Informed consent, CRF Completion Guidelines, etc.
. Reviewing the case report form against the subject's medical record
for completeness and accuracy.
. Adhere to all performance and productivity expectations with regard to
site management activities.
. Assess adequacy of potential clinical investigators and clinical trial
sites. Includes evaluation of facilities, personnel, patient referral
base, and adherence to GCP/ ICH.
. Support other team members and facilitate team cohesion play an active
role in personal training and development needs.
Clinical Research Associate
Vion Pharmaceuticals December 2005 to
November 2007
New Haven, CT.
. Work on Clinical Trials Focused on PHASE II Oncology studies on
prostate cancer.
. Study the effectiveness of 3-AP Triapine in treating patients who have
advanced prostate cancer.
Job Responsibilities:
. Determine the PSA levels to measure the disease characteristics.
. Participate in the direction, planning, execution and interpretation
of the clinical research project.
. Verify subject safety and site adherence to FDA Regulations and
ICH/GCP Guidelines.
. Review patient study records, case report forms, source-documents and
other materials.
. Participate in development of standard informed consent and other
related study documents and forms, as needed.
. Ensure that AE,SAE and Non SAE's Likely or Unlikely related or
unrelated are properly documented and reported to drug safety in
proper time frame.
. Develop and implement independently corrective and preventive actions
at sites and provide continuous compliance.
. Demonstrate superior communication and organizational skills required
for overseeing clinical studies.
Clinical Research Associate
Sepracor, Inc.
March 2004 to August 2005
Marlborough MA.
. Contribution in developing and authoring Clinical Trial Protocol for
PHASE III studies on Chronic Obstructive Pulmonary Disease.
. Evaluate the safety and effectiveness of arformoterol in patients with
Chronic Obstructive Pulmonary Disease.
Job Responsibilities:
. Detail knowledge of internal SOP's, FDA/ICH guidelines to GCP's and
regulatory compliance.
. Design and review confidentiality agreements, informed consent forms
and clinical trial agreements and other study specific forms.
. Assist in preparation and completion of IND, BLA, and NDA documents as
well as product annual reports and final study reports.
. Review regulatory documents and clinical site informed consent forms
for accuracy and regulatory compliance.
. Performs data management review, including in-house CRF review, and
alerts project managers and data managers to emerging issues with CRF
completion.
. Manage study site activities and provides ongoing updates of site
status to management.
. Ensure that Adverse Events are reported appropriately, accurately and
in a timely manner and follow-up activities are conducted as
necessary.
. Coordinate with the site management team to provide centralized site
support, communication and coordination, to assure accurate and timely
completion of all contracted activities.
. Exhibits strong planning and organizational skills and the ability to
work effectively in a dynamic environment.
Curricular Practical Training
Emcure Pharmaceuticals
March 2003 to December 2003
East Brunswick, NJ
. Work with in formulation department for control release formulations.
. Work with in preformulation department for excipients compatibility
studies.
. Accelerated stability of prototypes, selection of lead prototype and
reformulation of existing products.
. Work with in coating department for coating of tablets as film or
sugar coating.
. Work within the facility to manufacture supplies to support clinical
trials.
Techinical Skills:
. Have a good communication skills and through knowledge of Medical
terminology.
. Can work independently or in a team environment efficiently, highly
self-motivated team member with a customer-oriented approach.
. Detail knowledge of Ms Office and other IT infrastructure required for
business support.
Education:
Long Island University
Brooklyn, NY
Dec 2003
Masters of Science - Industrial and Physical Pharmacy
North Gujarat University
Gujarat, India
Dec 2001
Bachelor - Pharmacy