Management Project
Resume:
NASRIN S KARUTHA MEERA HASAN
Phone: 973-***-****
Edison NJ 08817
acxkkp@r.postjobfree.com
To find a challenging position in the field of Life Sciences, mainly in Clinical Research, where my knowledge and skills are best utilized.
Summary
In-depth knowledge of Clinical Data Management (CDM), Clinical Trial Management (CTM) and Clinical Project Management (CPM)
Working knowledge of Clinical Data Management Tools; such as Medidata Rave and Oracle Clinical
Comprehensive knowledge of Good Clinical Practices, ICH and FDA Guidelines
Knowledge of 21 CFR Part 11 and HIPAA
Proficiency with Drug Development and Approval Process
Coordinating with data management teams to identify, capture, document and resolve problems during subject enrollment, study data and study progress
Updating status to team members and project management, resolving site issues and facilitate to meet project timelines
Strong analytical, problem solving and management skills; demonstrated proficiency in leading and mentoring individuals to maximize productivity, while forming unified team environment
Professional Experience
Sollers Inc
Edison, New Jersey
Position : Clinical Research Associate (CRA) Intern
Duration : February 2016 – till date
Responsibilities:
In-house monitoring of sites for inspection, support clinical monitoring staff for visit preparation and ensuring accuracy of data
Examined and reconciled all essential documents in Trial Master File (TMF), and reviewed it against Site Master File (SMF) to ensure that they are in compliance with Protocol, SOPs, GCP and other local Regulatory Requirements
Reviewed completed Case Report Forms (CRFs) and verified it against the source document (SDV)
Reviewed all reported Adverse Events (AE) and Serious Adverse Events (SAE), notified sites according to the protocol
Collected IRB approval documents, Protocol, Informed Consent form, Investigator Brochure and amendments, if any, from the site
Verified the date and signature on informed consent form prior the start of the study
Obtained Screening and Enrollment Log, Delegation of duties log from the sites periodically
Escalated Protocol Deviations and any other site-level issues
Case Report Forms designing in Oracle clinical
Made sure the site staffs gets required system access and trainings on the protocol, and other study specific documents
Maintained CVs, medical licenses and protocol specific training certificates of the newly added site staff
Reconciled and verified the receipt, handling, accounting, storage conditions, availability of investigational products and take stock of the unused ones
Guided sites in maintenance of regulatory documentation throughout trials to accurately reflect ongoing activities of participating sites and personnel
Clinical trial experience in Phase II and Phase III studies; Cardiovascular and Diabetes
Masjid Al-Wali
Edison, New Jersey
Position : Faculty (Volunteer)
Duration : September 2015 – Till Date
Responsibilities:
Teaching and mentoring Kindergarten (KG) students
Coordinating between departments in organizing various cultural and academic events
Training
Duration : 6 Months
CLINICAL TRAINING PROGRAM at Sports Medicine Centre conducted by the Fitness Foundation Academy, YMCA College of Physical Education, Chennai (India)
CLINICAL TRAINING in the LOCOCMOTAR HANDICAPPED TRAINING at Department of Physical Medicine and Rehabilitation, Department of Orthopedics, Department of Neurology, Department of Burns, Plastic and Reconstructive Surgery at the Government Kilpauk Medical College and Hospital Chennai (India)
Completed clinical training in the Department of Cardiac Rehabilitation and Physical Medicine at The Madras Medical Mission, Mogappair, Chennai (India)
Completed training at Gremaltes Hospital, Chennai (India)
Completed clinical training in in-patients and out-patients of Orthopedics, Reconstructive Surgery (Total Hip and Knee Replacements, Hemiarthroplasty, Arthroscopy, General Medical Unit, Emergency, ICU, Neurology, Rehabilitation, Burns Unit, Plastic Surgery, Rheumatology & Cardiothoracic Departments at Vijaya Institute of Trauma & Orthopedics, Chennai (India)
Trained in an Early Intervention Centre for Children with Mental Retardation and Associated Disabilities at Madhuram Narayanan Center for Exceptional Children, Chennai (India)
Project
Name : Effect of Massage and Ultra Sound in Delayed Onset of Muscle Soreness
Duration : 12 Months
Description :
Delayed onset muscle soreness (DOMS) is the pain and stiffness felt in muscles several hours to days after unaccustomed or strenuous exercise. Selected subjects under similar criteria and made them do 25 repetitions of elbow extension with weights (Triceps eccentric contractions). Divided them into three groups; Group A – provided with ultrasound alone, Group B – treated with massage and ultrasound and Group C – provided with none. Compared the results and concluded that the group which received ultrasound and massage had the best result in recovering from DOMS.
Educational Qualification
Bachelor of Physiotherapy - 2008 – Mohamed Sathak A. J. (MSAJ) College of Physiotherapy (The Tamil Nadu Dr. M.G.R. Medical University), Chennai (India)
Higher Secondary Course (Science) – 2002 – Singarampillai Girls Higher Secondary School (Department of Government Examinations), Chennai (India)
Certifications
Clinical Trial Management (CTM) from Sollers Inc, New Jersey
Skills
Clinical : Clinical Trial Management System (CTMS)
Clinical Data Management (CDM)
Clinical Project Management (CPM)
Regulatory Medical Writing
Operating Systems : Windows XP / 7
Packages : MS Office Suite (Word, Excel and Power Point), Adobe Acrobat
Languages Known
English, Hindi and Tamil
Academic Activities
Attended the “Continuing Medical Education Program” on Rehabilitation Medicine ‘REHABASICS 2005’ in Chennai (India) on December 2005
Attended South India Physiotherapy Conference ‘PHYSIOFEST-06’ in Chennai (India) on December 2006
Attended southern regional CME programme PHYSIOA(I)MS 2007 – “Innovations of Physical Therapy” at Aalim Muhammed Salegh College of Physiotherapy in Chennai (India) on April 2007
Presented paper on “Delayed Onset of Muscle Soreness” and awarded second prize at South Regional CME Program, PHYSIOA(I)MS 2007 – “Innovations of Physical Therapy” by Aalim Muhammed Salegh College of Physiotherapy in Chennai (India) on April 2007
Attended 3-day workshop on ‘Motor Relearning Program’ at Synergy held at Mohamed Sathak A.J. College of Physiotherapy, Chennai (India) on July 2007
Participated in a seminar on ‘Perspectives of Coronary Artery Disease and its prevention’ at College of Physiotherapy, Saveetha University, Chennai (India) on November 2006
Conducted 3-day Polio Camp in Royapuram Study Skill Training Program at Corporation Higher Secondary School, Chennai (India)
Actively participated in the study skill training program conducted for 9th and 11th grade students of Corporation Higher Secondary School, Chennai (India)
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