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Clinical Management

Location:
Rego Park, NY, 11374
Posted:
April 28, 2010

Contact this candidate

Resume:

Chintan Chandak

**-** **** ** *** *F

Rego Park, NY 11374

347-***-****

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



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