Name: Madhurima Somisetty

Mobile Number: +1-402-***-****

Email Id : ad3grd@r.postjobfree.com

OBJECTIVE

A flexible, careful, keen, and healthy individual to work in a healthy environment where I use the right blend of skills and knowledge which I possess for achieving the organization’s objective as well as the development of my personality and capability in this corporate world.

EDUCATION

Bachelor of dental surgery- YSR University of health sciences, India.

SKILLS

Strategic decision making with proven success in building and executing effective plans to achieve desired outcomes.

Strong planning skills, demonstrated through the ability to prioritize tasks and manage multiple projects simultaneously.

Analytical thinking, with a talent for synthesizing complex information and using data driven insights to inform decisions.

Excellent communication skills, with the ability to effectively communicate with patients, medical professionals, and team members.

Profound knowledge on medical terminology, statistics, and Research methodologies with experience in designing and executing clinical trials.

In-depth knowledge of GCP, ICH Guidelines, and FDA regulations with experience in adhering to strict compliance requirements.

Experience working with IRB, CRF, Informed consents.

Knowledge of CTMS (clinical trial master systems), Research electronic data capture (Redcap), Clinical SAS.

Practical experience with SPSS Software (statistical package for social sciences).

Proficient in the using MS Office, Excel, power point and outlook, with experience in creating visually compelling presentations and reports.

Knowledge of regulatory requirements in the USA, including FDA regulations and HIPPA laws and regulations.

Professional Experience

CKS Teja Institute of Dental Science and Research - AP, INDIA

Research Assistant

Collaborate with Interdisciplinary Research teams to carry out clinical trials for oral cancer research, including patient enrollment, qualification visits, and site initiation visits.

Worked in collaboration on Facilitating daily clinical trial operations and adhering to principal investigator and other team members.

Gathered required data from research protocols, operation manuals, and case report forms.

Selected Potential research study participants by Screening the patient records.

Involved in collecting informed consents, taking case report forms.

Maintained the investigational product (IP)

Observed strict safety measures, including checking medications dosage before administering to patients.

Performed basic lab procedures and was responsible for storing and shipping lab specimens.

Observed and collected adverse events (AE), serious adverse events (SAE)

Collecting the required case data from the participants.

Assist in submissions of required documents to ethical committee and regulatory bodies including the Indian council of medical research (ICMR) and drug controller General of India (DCGI)

Provided the required support for the project according to SOP, ICH guidelines and GCP.

Performed the administrative duties given by the management.

CERTIFICATIONS:

CITI Good clinical practice – CITI program (Issued Date: Jan 8th, 2024, CTN Exp Date: Jan 8th, 2027)

Human Research Protection Foundational Training Certification.

CPR Certification – CPR and First Aid

Certified Dental Auxiliary

Dental assistant (Dr Amber M. Allen Aesthetic and Family Dentistry) DEC 2023 – Till Now

Omaha, NE

Dental assistant (Whispering Ridge Family Dentistry) JUL 2023 – DEC 2023

Omaha, NE

Rainbow Dental Clinic – AP, INDIA SEP 2016 - OCT 2017

Dentist

PERSONAL SKILLS

Patient assessment.

Wound care.

Decision making.

Responding to emergencies.

Recording vitals.

Patient management.

Good communication skills.

Willingness to learn new things.

Microsoft knowledge.

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