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Clinical Research Management

Location:
Jersey City, NJ
Salary:
$60000
Posted:
December 15, 2016

Contact this candidate

Resume:

Dr. Anjani Patel

***, ********* ***, ***** *, Jersey City, NJ 07307

acxwx6@r.postjobfree.com

Cell: 216-***-****

Work Status: L2 EAD – no requirement of work permit

Self-driven, innovative and quick learning individual with excellent interpersonal skills, communication skills, relationship building abilities, and English fluency. Graduated with Masters in Health Care Administration and have an excellent knowledge about clinical research. Wish to work for one of the best clinical research organizations in a challenging environment with latest technologies and contribute towards organizational goals.

EXPERIENCE:

CIMS Hospital, Ahmedabad, India Nov’11 -Jan’13

Clinical Researcher

Business Development Assistant

• Performed and supervised all necessary clinical research functions including patient enrollment, medical histories evaluation, screening and randomization, IEC approvals, source documentation, transcription of source documents to case report forms, and compliance check of all records with ICH GCP guidelines.

• Coordinated and managed clinical trial (Phase II/III/IV) related activities like communication with CRO, sponsor and ethics committee, informed consent process, eligibility criteria selection, IP dispensing & compliance, AE/SAE monitoring & reporting according to regulatory requirement, follow up of patients, maintenance of source documents and investigator site file, and completion of protocol required log.

• Participated in site feasibility surveys, communicated effectively with BDA/CRA for new projects and site evaluation during pre-trial assessment meetings and attended business meetings in India and overseas.

CIMS Hospital, Ahmedabad, India Aug’08-Mar’11

Sr. Clinical Research Coordinator

Business Development Assistant

• Worked with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.

• Maintained effective and ongoing communication with sponsor, research participants and PI during the course of different trials

• Participated in Site Feasibility Surveys and communicated effectively with BDA/CRA for new projects and for site evaluation during pre-trial assessment meetings.

• Attended business meetings in India and overseas.

• Gained experience in filling patient screening form, screening call worksheet (IVRS), informed consent, and CRFs along with getting patient medical records and medical history and writing patient consent summary report.

• Participated in global phase I, II, III & IV (drug & device trials) clinical trials.

• Reviewed and understood site master files, investigator’s brochure, clinical protocols, investigator’s meeting manuals, and SOPs.

• Well versed with ICH-GCP guidelines, CRF completion guidelines, FDA rules & regulations, IRB/IEC submission, approval, query resolution and correspondence, source documentation, ICF guidelines, IVRS & IWRS, & AE/SAE reporting.

• Gained through knowledge of site selection, site initiation, site monitoring, and site close out activities.

• Experience in eCRF entries by using different databases including Phase Forward, Mednet Solutions, Clinsource & Oracle in various clinical trails.

• Worked with PI to manage daily activities of the study including problem solving, communication and protocol management.

Moses Taylor Hospital, Scranton, PA Jun’06-Feb’07

Mid-Valley Hospital, Peckville, PA

Administrative Resident

• Review of hospital charge master and pricing strategies for business development and revenue making.

• Involvement in administrative projects of different departments (senior management, marketing, organizational improvement, patient care services, quality improvement, medical and clinical rotations, corporate compliance, governance, IT, operational management and database management) of hospital.

• Meaningful participation in senior management projects including tuberculosis infection control plan and policy update of different hospital departments.

• Development of business & marketing strategies to manage daily operations of hospital and establishment of rules and regulations based on JCAHO and HIPAA guidelines for corporate compliance.

• Health market assessment, medical/clinical project planning, utilization management, disease management and case management, identification of key business issues and evaluation of project development activities.

Mercy Health Partners, Scranton, PA Feb’06-Apr’06

Administrative Intern

• Participated in administrative projects of different departments (quality improvement, administration, marketing) of the hospital.

• Developed quality improvement strategies and participated in volunteer activities for hospital marketing and professional services.

• Development of marketing and business strategies for new hospital programs and projects.

• Relationship building with healthcare organizations, healthcare providers and area hospitals.

EDUCATION:

University of Scranton, Scranton, PA

Masters in Health Administration / GPA: 3.79

Gujarat Homeopathic Medical College, Gujarat, India

Bachelors of Homeopathic Medicine & Surgery / GPA: 3.7

INVESTIGATOR’S MEETINGS:

• Sponsored by J &J in Banglore, India, November 20, 2010 for Cardiovascular Diseases with T2DM.

• Sponsored by Pfizer & BMS in Kualalumpur, Malaysia, February 9 – 11, 2009 for Venous Thromboembolism.

• Sponsored by J & J GCO in Goa, India, January 30 - 31, 2009 for Acute Coronary Syndrome.

CONFERENCES/SEMINARS:

• CIMS-Con 2013, Ahmedabad, India, January 4-6, 2013.

• CIMS-Con 2011, Ahmedabad, India, February 3-5, 2011.

• 3C-Con 2010, Ahmedabad, India, January 7-9, 2010.

• Sanofi Aventis ICH GCP Training Seminar 2009, Ahmedabad, India, October 10, 2009.

• Sanofi Aventis ICH GCP Training Seminar 2009, Ahmedabad, India, October 9, 2009.

• GP-Con 2009, Ahmedabad, India, May 24, 2009.

• 3C-Con 2009, Ahmedabad, India, January 9-11, 2009.

• BHAA Conference, Chicago, USA, March 28-30, 2007.

• BHAA Conference, Chicago, USA, March 15-17, 2006.

PEER-REVIEWED PROCEEDINGS:

• Upadhyay, A., & West, D.J. Developing grant writing competencies during graduate training.

Proceedings of the Business and Health Administration Association, Chicago, Illinois, March 15-17, 2006.

• Upadhyay, A., Costello, M., & West, D. J. Leadership competencies needed to successfully navigate change in healthcare.

Proceedings of the Business and Health Administration Association, Chicago, Illinois, March 28-30, 2007.

• Upadhyay, A., Stevens, A., & West, D. J. Leadership competencies needed to manage critical access hospitals. Proceedings of the Business and Health Administration Association, Chicago, Illinois, March 28-30, 2007.



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