Dear Sir/ madam,

Greetings! Hope everyone is doing well and staying safe!

I am Visakha Ankinapalli recently relocated to United States and having work permit.

Clinical Research professional with more than 14 years of experience including development of drugs, biologicals, vaccines, devises for phase I – IV trials. Recent experience includes Lead Clinical Research Coordinator, core responsibilities include overall management of studies starting from site feasibility till site closure and archival of documents in compliance with protocols and local and international regulatory requirements, Investigator Site File (ISF)/ Trail Master File (TMF) management, IRB/IEC communications, safety reporting, budget management, etc.,

Prior to CRC, worked as Laboratory technician and core responsibilities include overall management of biological samples including receipt and analysis, reporting of results, and managing relevant documentation in compliance with laboratory procedures. Having hands on experience on High Performance Liquid Chromatography (HPLC), FACS, DNA isolation techniques, etc.,

Completed certification training program on “Advanced International pharmacovigilance and Argus safety certification” course from Certified Clinical Research Professional Society (CCRPS) in Sep2022.

Kindly refer to the attached Curriculum vitae for detailed information.

I am open to join any position including entry level to support my family. I Prefer home based opportunity however open to hybrid or on-site opportunities as well.

I shall be grateful if you would kindly provide me an opportunity to serve your prestigious organization. I also assure you of my utmost to prove myself worthy of your expectations.

Thanking you in advance for your time and support!

Cordially,

Visakha Ankinapalli

Mob: +1-951-***-****

adt0bc@r.postjobfree.com

VISAKHA ANKINAPALLI

Dallas, TX 75039

+1-951-***-****

adt0bc@r.postjobfree.com

PROFESSIONAL SUMMARY

Experienced Clinical Research professional committed to healthcare with the ability to lead and inspire change, more than 14 years of hands-on experience and knowledge within healthcare specialized in clinical research, drug development, strategy, and operations. Proven to increase efficacies by identifying challenging areas, and propose solutions in various positions, such as, Lead Clinical Research Coordinator (Site Management Organization) and Lab technician. Core competencies include: *Clinical Research *Protocol and regulatory compliance * Investigator Site File (ISF)/ Trail Master File (TMF) management *People Management *Clinical/ Safety sample analysis *Problem Resolution *Drug Safety *Team Leadership *Risk Management *Budget Management *Electronic Data Capture (EDC).

THERAPEUTIC AREA EXPERTISE

Areas of therapeutic exposure include but are not limited to Psychiatry, Cardiology and Vascular Disease, Dermatology, Oncology, Musculoskeletal, Nephrology, Endocrinology, Gastroenterology, Ophthalmology, Immunology, Neurology, Immunology, Obstetrics/Gynecology, Neurology, Family Medicine, Hematology, Sleep, Rheumatology, Otolaryngology, Pulmonology/Respiratory, Urology, Hepatology, Pediatrics and COVID-19. Also worked for couple of devise studies.

PROFESSIONAL TRAININGS/ CERTIFICATIONS

Completed certification training program on “Advanced International pharmacovigilance and Argus safety certification” course from Certified Clinical Research Professional Society (CCRPS) in Sep2022.

Trainings including ICH GCP, ICH GCP r2, IATA training, etc., from 2007 to 2021.

PROFESSIONAL EXPERIENCE

BIO-MEDICO RESEARCH, HYDERABAD, TELANGANA, INDIA

LEAD CLINICAL RESEARCH COORDINATOR

DEC2011 TO JUL2022

Providing clinical trial related clinical site (hospital) services to a contract research organization (CRO), pharmaceutical company, biotechnology company and medical device company.

Supporting and working on pre-SIV activities including feasibility questionnaires, qualification visits, providing required documents including CVs, MLs, GCP training certificates and any other relevant study specific documents.

Supporting system set-up activities including IBB approvals, IMP and other study supplies, getting access to study specific systems and tools.

Consenting process management

IRB/ IEC submissions and relevant communications

Identifying and qualifying the sites as per the client requirements

Accommodating site initiation/ monitoring and close-out as contracted

Evaluate patient population and support with rapid recruitment and managing subject visits

Source Documentation, Investigator Site File (ISF)/ Trail Master File (TMF) management

EDC entry and safety reporting

Managing clinical supplies including Investigational Medicinal Products

Preparing and supporting sponsor audits and regulatory inspections

Managing a network of clinical investigative sites (hospitals) and doctors

Managing clinical projects within various hospitals

Attending client meetings to help the research team

Reviewing and managing Quality Issues

Business development

Resource and budget management

Key Accomplishments:

oHandled various sponsor audits and Drug Controller General of India (DCGI) inspections without major and critical findings

oCompleted more than 15 studies within the agreed timelines

GLOBAL CLINICAL RESEARH SERVICES, GLOBAL HOSPITALS, HYDERABAD, INDIA

CLINICAL RESEARCH COORDINATOR

MAY2007 TO OCT2010

Supporting the Investigator in Informed Consent process and documentation.

Scheduling and conducting subject visits as per protocol

Managing Investigator Site File (ISF)

Preparing site for Site Selection visit, Site initiation and site close-out visits.

Preparing the site for monitoring and audits and hosting them

Completing Electronic Case Report Form (Oracle based eCRF, Inform IT software based eCRF, Citrix software & Oracle RDC software, Icon software eCRF) and answering the queries.

Reviewing of on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and providing remedial training and/or initiates corrective action as required to the less experienced/ new CRCs.

To give the daily tasks to study team coordinators and initiate to complete the work within timelines and update the report to department head.

Handling Institutional Ethics Committee (IEC) submissions, approvals, and notifications.

Supporting Scientific Advisory Committee (SAC) & IEC meetings regularly

Investigational Medicinal Product (IMP) and sample management

Supporting in safety reporting to sponsor and regulatory authorities within the timelines

Interacting with PI, CROs, research team, pharmacy, IEC, finance, and other departments impacted by the research.

Key Accomplishments:

oHandled external Sponsors Audit, for a very highly recruited (190 subjects) diabetic study happened in Dec2007 without critical findings.

ST. THERESA HOSPITAL, HYDERABAD, INDIA

LAB TECHNICIAN

JUN2003 TO MAR2007

Processing of blood samples for biochemistry, hematology, serology, and urinalysis

Microbial cultures and identification of microbes

Sterilization techniques

worked with FACS (florescence activated cell sorter) i.e., (CD3, CD4, CD8)

Isolation, identification of microbes by DADE BEHRING i.e., MICRO SCANNING using BACTEC cultures.

ELISA methods using DADE analyzer.

Antigen antibody reactions

Amplification of DNA using PCR technique.

Isolation of DNA techniques

Calibration and maintenance of equipment

Following GDP, GCP and GLP Guidelines

Waste management

EDUCATION

Aug/Sep2000-Apr2003

Master of Science (M.Sc.) in Biotechnology from University of Madras (second class), Chennai, Tamil Nadu, India

Apr1997-Apr2000

Bachelor of Science (B.Sc.) from Sri Venkateshwara University (first class), Thirupathi, Chittoor, India

LANGUAGES

Telugu

Native speaker

English

Fluent

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