Clinical Research Associate, Coordinator,Quality Assurance Medical

SARADADEVI PENDYALA

****, ********** ****, ***: 647-***-****

Mississauga, ON, L4T 2N6 **********@*****.***

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OBJECTIVE .

To contribute my strong skills and experience as Clinical Trials and Data Management

Research Associate

SUMMARY OF SKILLS

• Self-motivated, professional with 6+ years of experience in Clinical Research, a Post

Graduate Diploma in Clinical Research and a 4 yrs Bachelors Degree in Medical

Science

• Thorough knowledge of diseases, causative organisms as well as drug therapy techniques and

Clinical Research Methodologies

• Excellent management skills in Clinical trials, implementing and Coordinating in all aspects

of data collection and Source Documentation as per ICH, GCP guidelines

• Proficiency in Medical Terminology and Medical Equipment used in general practices as

well as in surgeries

• Skilled in Quality Assurance, Data Quality analysis, and Quality Control, ensuring

compliance with ICH, GCP and SOPs

• Advanced computer skills in MS Word, Excel, PowerPoint, Internet, and E-mail

• Excellent keyboard skills with a typing speed of 60-80 wpm

• Broad knowledge of Anatomy, physiology, Oncology, pathology, and surgery

• Strong Organizational and problem solving skills, with the ability to adapt quickly to new

environments

• Excellent interpersonal, time management, Prioritization and facilitation skills

• Effective team player with the ability to work independently in a high pressure fast paced

work environment

• In-depth experience dealing with patients and co-workers from different cultural

backgrounds

• Result and detail- oriented individual with exceptional written and verbal communication in

both English and Hindi

RELEVANT SKILLS / EXPERIENCE

• Prepared and verified source documents and monitored the safety and efficacy throughout the

study period

• Knowledge of Research Ethics Board applications and amendments for approval of study

drug

• Retrieved articles from the medical journals to maintain literature databases

• Coordinated and streamlined activities to ensure maximum use of resources

• Interacted with Investigators, coordinators and clients regarding New Drug Application, and

Adverse Events

• Strong knowledge in maintaining Regulatory submission documents for the Regulatory

compilation

SARADADEVI PENDYALA

7498, Netherwood Road, Tel: 647-***-****

Mississauga, ON, L4T 2N6 **********@*****.***

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• Skilled in monitoring study sites during Site-Placement, Site-Initiation and Site Close-up

• Interpreted medical records, analyzed and assisted in database development

• Maintained accurate log-sheets, developed and implemented regulatory requirements for the

internal SOPs

• Participated in BioTRAC Investigators Meeting recently on Sat 22 March 2014 regarding

study updates and Protocol Amendments

EMPLOYMENT HISTORY

Clinical Research Study Coordinator (Rheumatology) July 2013- Present

Bramalea Community Health Care, Brampton,Canada

• Enrolled potential patients for the clinical trials as per the inclusion and exclusion criteria

according to the Protocol

• Obtained informed consent for the study trial, scheduled appointments for the follow-up

visits

• Reviewed, completed and reported Case Report Forms as well as Data Clarification

forms according to the internal sponsors Standard Operation Procedures in a timely fashion

• Reported Adverse Events and Serious Adverse Events to the Sponsors and IRBs in an

timely manner

• Coordinated study related documents in the Trail Master File, updated Investigator

Brochures, Protocol revisions, amendments to required Regulatory agencies

• Assisted to the Monitors during the site monitoring visits during site initiation, follow-up

visits as well as site close-up visits.

• Participated with the investigators, Coordinators, during study related meetings and

conferences.

• Extensively used Hospital Medi-Tec to retrieve the information from visit history, health

records, demographics, patient case history, laboratory as well as diagnostic information for

the final reports to ensure accuracy and completeness as per the ICH-GCP and SOPs

• Communicated with all relevant departments to ensure every aspect of the study can be

completed according to requirements and problems were solved wherever necessary

• Participated in the Investigator’s meetings, educational programs, workshops and seminars

to broaden knowledge, update and develop new skills as required

Clinical Research Data Management Quality Controller May 2012- June-2013

Regional Kidney Wellness Centre, Brampton,Canada

(William Osler Health System)

• Reviewed Source Documents and entered the data in the EDC (electronic data capture) for

validation

• Verified data electronically as well as well as manually to ensure data is captured

appropriately as per the Protocol and internal SOPs and guidelines

SARADADEVI PENDYALA

7498, Netherwood Road, Tel: 647-***-****

Mississauga, ON, L4T 2N6 **********@*****.***

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• Extensively used Medidata Rave to support EDC and clinical data management systems for

capturing, managing and reporting the data to the data management department

• Extensively used quality assurance procedures to ensure high quality data for the Phase I

studies

• Reviewed and prepared Case Report Forms against the subjects medical records for

completeness and accuracy as per the study protocol

• Extensively used Accuro EMR, encounter notes, virtual charts to maintain proper data as per

the schedule

• Verified documents of the informed consent process for each study subject

• Ensured non-serious and serious adverse events are properly documented and reported to

the appropriate Sponsors and Data management departments

• Ensured the filling and maintenance of the required regulatory documents

• Ensured source documentation is accurate including medication profiles, and that copies of

test reports, progress notes, toxicity assessments are available in patient medical charts

• Tracked enrollment status of subjects and document dropout information such as dropout

causes and subject contact efforts

• Participated in the development of study protocols including guidelines for administration

and data collection procedures.

• Good interpersonal skills, worked with allied health team, communicated all Protocol and

practice changes with Multi-disciplinary team

• Excellent experience in Phase I-II studies

• Assisted in Data Management personnel in resolving data discrepancies to ensure Quality

assurance as per the SOPs

• Extensively used Medidata Rave safety gateway solutions using Standard Operating

Procdures

Clinical Research Associate Sep 2011-April 2012

Global Research Pharma Canada (Internship), Toronto, Canada

• Designed and reviewed Case Report Forms according to schedule of activities and visits

• Identified Potential Sites for clinical trails

• Expertise in various trail process methodologies: Site Selection,Site Initiation, Site-

Monitoring, and Site Close-Out

• Involved in the initial training and communication of adverse event reporting requirements

• Performed study drug accountability

• Maintained accurate Storage, dispensing, destruction and accountability of the

investigational drugs

• Monitored the physician adheres to Good Clinical Practices and the study protocol

• Discussed Study Protocols (study objectives, purpose, endpoints) with the Monitors to

resolve any data discrepancies

• Reviewed regulatory documents and discussed trial status with the study team

• Record adverse event and side effect data and confer with investigators regarding the

reporting of events to oversight agencies.

SARADADEVI PENDYALA

7498, Netherwood Road, Tel: 647-***-****

Mississauga, ON, L4T 2N6 **********@*****.***

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• Schedule subjects for appointments, procedures, or inpatient stays as required by study

protocols.

• Reviewed scientific literature, participated in continuing education activities, attend

conferences and seminars to maintain current knowledge of clinical studies affairs and issues.

• Contact outside health care providers and communicate with subjects to obtain follow-up

information.

• Instruct research staff in scientific and procedural aspects of studies including standards of

care, informed consent procedures, and documentation procedures.

• Solicit industry-sponsored trials through contacts and professional organizations.

Clinical Research Associate 2010-2011

AAPS, Toronto,Canada

• Obtained informed consent from the clients according to inclusion and exclusion criteria

to enroll subjects for questionnaire-based research studies as per the Protocol

• Site Investigator File Handling

• Maintained TMF, Participated in the Randomization procedures, including the blind

studies

• Collaborated with investigators to prepare presentations, reports of clinical study

procedures, results, and conclusions.

• Directed the requisition, collection, labeling, storage, or shipment of specimens.

• Order drugs or devices necessary for study completion.

• Prepare final and interim Clinical Trial report for sponsor and Ethics committee

requirements

• Reviewed proposed study protocols to evaluate factors such as sample collection

processes, data management plans, and potential subject risks.

• Assess eligibility of potential subjects through methods such as screening interviews,

reviews of medical records, and discussions with physicians •

• Register protocol patients with appropriate statistical centers as required

Clinical Research Monitor 2005-2008

Neon Laboratories, India

• Reviewed quality assurance statements for final reports, supported computer validation

and equipment validation activities, as well as other duties as assigned

• Strong knowledge in organizing site monitoring reports, issued Data resolution forms,

CRF collection and approval of essential documentation during the study period

• Reviewed, verified patient diaries, regarding Study Drug Application and adverse events

• Good experience in monitoring Vital Signs, Physical and General Examination of the

study subjects in a periodical basis

• Exceptional Knowledge in monitoring single/multi-center trials to ensure accuracy and

completeness including scoring, entering and cleaning data for data base analysis as for Protocol,

GCP, and Regulatory requirements

SARADADEVI PENDYALA

7498, Netherwood Road, Tel: 647-***-****

Mississauga, ON, L4T 2N6 **********@*****.***

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• Prepared and participated in quality assurance audits conducted by study sponsors, federal

agencies, as well as specially designated review groups.

• Worked on Phase III Oncology studies especially in Breast Cancer Tumor

Clinical Research Assistant (Data entry) 2003-2005

Neon Laboratories, India

• Maintained accurate, detailed reports and records.

• Entered the data from the source documents to the Case Report Forms electronically as

well as manually

• Entered the Lab reports and Medications into the data for accuracy compliance as per the

study Protocol to ensure accuracy and integrity of the Study

• ICF Process/Record,IP Handling

• Patient Recruitment/Schedule Patient's visits/Patient Follow ups

• Patient Counseling

• AE/SAE Identifying, Recording, Reporting and Follow up till resolution

• Prepared the site for GCP and protocol Compliance according to sponsor requirements

Medical Transcriptionist 2000-2003

Care Technologies, India

• Transcribed the Medical reports such as consultation, progress, Discharge notes as per the

dictation for various US Hospitals.

• Excellent key board skills, Transcribed 80 wpm by using Dicta phones.

• Proficiency in computer skills in MS Word, MS Office, Excel, Power point, internet and

outlook

• Proficiency in Medical Terminology and Medical Equipment used in general practices as

well as in surgeries

EDUCATION

Post Graduate Diploma in Clinical Research program

Academy of Applied Pharmaceutical Sciences, Toronto

Bachelor of Homoeopathic Medicine and Surgery

NTR University of Health Sciences, India

Bachelor of Science

SV University, India

PROFESSIONAL DEVELOPMENT

SARADADEVI PENDYALA

7498, Netherwood Road, Tel: 647-***-****

Mississauga, ON, L4T 2N6 **********@*****.***

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Certificate in Medical Transcriptionist – Care Technologies, India

REFERENCES AVAILABLE UPON REQUEST

Contact this candidate