• Job Target: Clinical Data Coordinator
• Employment Status: Unspecified
• Experience Level: Not Specified
• Seeking: Full-Time
• Industry: Pharmaceutical Resumes

• Salary: 55000 to 65000
• Degree: Not Specified
• Security Clearance: None
• Travel: Not Specified
• Relocate:: No

Objective

Looking for a job in a Pharmaceutical/ CRO location Hina Maniar Hinany@yahoo.com 448, Abbott Road 201 265 8591, 201 403 7987 Paramus, New Jersey,NJ 07652 Objective I have a strong desire to obtain a position in clinical setting working independently or with a team oriented environment utilizing my strong written and verbal communication, analytical and interpersonal skills, along with my attention to detail and high organization skills. Qualifications Certifications  Completed CRA certification and training - from Medical Research Management institute (CRTI).  Completed the HIPAA course  Knowledge of medical and clinical research techniques in Oncology. I have 6 months experience as a Clinical data coordinator and looking to find a opportunity as a CRA. I am handling 12 studies in Oncolgy from companies like Bristol Myers Squibb, Novartis, Pharmion and ECOG. Education 1993 Ph D in Immunology from Cancer Research Institute (Bombay University) 1985 M.Sc in Microbiology (Bombay University) 1981 Bachelors in Microbiology (Bombay University). Current Position: 2005-Clinical Data Coordinator at Hackensack Medical Center. Responsibilities: Maintenance of study documentation according to study protocol and FDA regulations:  Timely serious adverse event (SAE) reporting.  Preparedness for monitor/audit visits.  Organized and accurate source/CRF documentation.  Maintain FDA/IRB documentation including: 1572, informed consent and CVs. Maintain timely submissions of screening logs, enrollment logs, and referral logs. Assure compliance with all FDA regulations and company procedures. I perform proper source documentation, data collection, drug accountability, lab specimen collection, and lab processing for all trials to maintain high quality data output.  Assist in the preparation of clinical study summary reports  Help to coordinate clinical studies, provide data verification, and assist in preparation of clinical summaries.  Collect, process, and track regulatory documentation as required by the FDA regulatory association.  Liaison with data coordinators at CRO sites. Other duties as assigned. Transferable competency requirements:  Communication skills (written, verbal, non-verbal)  Customer service (subjects, sponsors, co-workers)  Time management/efficiency  Working with teams  Safety  Problem solving Specific technical competency requirements:  Computer skills (MS Office and associated modules, Word, Excel, Power point and Internet) Work History Projects Undertaken and Responsibilities: 2003-2004 Sr. Research Associate, Phase I clinical trials and vaccine production under cGMP and preclinical Development .Memorial Sloan-Kettering Cancer Center, Gene Transfer and Somatic Cell Engineering Facility, New York. 1998-2002 Research Fellow, Memorial Sloan Kettering Institute, New York. 1995-1997 Research Associate, Rutgers University, New Jersey. 1993-1995 Research Fellow, Centrum for Bioteknic, NOVUM, Karolinska Institute, Sweden 1989-1993 PhD course work. 1992-1993 Scientific Officer B, Cancer Research Institute, Bombay, India. Professional Courses  Successfully completed the cGMP training from Sloan Kettering Institute .  Attended a audio conference series on Computer Validation in the Cell Therapy laboratory, 2004. It defines the basic requirements for validation of computer system, lists important elements of part 11 and how these elements affect cell therapy laboratory databases, explains validation issues and critical elements of an inventory management systems. Additional Certifications  Successfully completed the regulatory affairs credit course from CSUH. These courses in regulatory Affairs cover;  Overview to the laws governing development, manufacture and commercial distribution of drugs, biologic and medical device products(FDCA), and  Studies of current Good Manufacturing Practice regulations to assure quality of marketed products, application to manufacturer's organization, personnel, facilities, equipment, control systems, production, process controls, laboratory procedures and records (21 CFR 210, 211, 610 and 820, cGMPs- US FDA and EMEA, FDA and ICH regulations related to biologics). References Publication list and references will be available upon request

Job Target

Clinical Data Coordinator