Clinical research Study Coordinator

Sajala Vakalapudi

** * ******** **, ******, MA-**171

Email: acy4gy@r.postjobfree.com

EDUCATION:

Masters of Science in Regulatory Affairs and Health Policy -Massachusetts College of Pharmacy and Health Sciences University, Boston, MA. (Sep 2015 - Jun 2017)

Current GPA: 3.8

Bachelor Of Pharmacy - The Tamilnadu Dr. M.G.R Medical University, Chennai, India. (Oct 2007 - Aug 2011)

Cumulative GPA: 3.3

WORK EXPERIENCE:

Alzheimer’s Disease Center - Study Coordinator

Alzheimer’s Disease Center, 54 Miller st, Quincy, MA, USA (May 2016 - Present)

Research Experience:

●Participates in study initiation and close-out process.

●Understands study protocol and study consent forms.

●Completes the consenting process with the involvement of the Primary Investigator and inclusion/exclusion criteria to determine eligibility of study participants.

●Completes study visit activities including adverse event assessments, concomitant medication review, neuropsychological assessments, dispensing medication and vital signs.

●Completes the study Case Report Forms (CRF/eCRF).

●Schedules study participants, tracks the participant’s visits and projected dates of return as well as oversees all data management within the study.

●Interacts with the sponsor of the study on a regular basis and assists in obtaining necessary information for period IRB submissions.

●Familiar with Good Clinical Practices (GCP) complies with all company Standard Operating Procedures (SOP).

●Works collaboratively with other study coordinators and sites.

Gland Pharma Ltd, Hyderabad, India. (Jan 2012- Dec 2012)

Trainee Officer/ Intern in Drug Regulatory Affairs department.

●Collected and coordinated information and prepared regulatory documentation for submission to regulatory agencies or to commercial partners.

●Timely compiled materials for license renewals, updates, and registrations.

●Maintained regulatory files/database and chronologies in good order. Reviewed labeling and labels for compliance with regulatory requirements.

●Reviewed changes to existing products and SOPs to define the requirements for regulatory submissions.

●Maintained current knowledge of FDA and international regulation, guidance, and standards applicable to company products.

ACADEMIC RESEARCH:

MCPHS University, Longwood Medical Area, Boston, MA.

Research Title: Brain Imaging study of Acupuncture in Chronic Low Back Pain Patients. (Dec 2015)

Details:

●Prepared customized Informed Consent Form.

●Explained about what is Acupuncture, its background and uses.

●Explained about what is Brain Imaging and how the technologists or doctors or radiologists use FMRI (Functional Magnetic Resonance Imaging) to image the brain activities in patients.

●Tested Efficacy of Acupuncture in Chronic Low Back Pain patients by using fMRI.

●Explained about HIPAA (Health Insurance portability and Accountability Act).

ASSOCIATIONS:

●MCPHS University - Student Government Association - Member (Jan 2016)

●Regulatory Affairs Professional Society (RAPS) - Member (Mar 2015)

SKILLS and CERTIFICATIONS:

●ICH - GCP, Investigator Responsibilities, 2016.

●Good Clinical Practice, 2016.

●Transporting Dangerous Goods, 2016.

●Clinical Dementia Rating, 2016.

●Medidata RAVE Certified, 2016.

●Office for Human Research Protection (OHRP) Training for Developing Human Research Protection policies, procedures and regulatory compliance, 2015.

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