Clinical Research Management

RESUME

D.Raja shekar Reddy,

Society Colony,

Giddalur (Md),

Prakasham (Dist), PIN-523357.

E-mail: **********@*****.***

Andhra Pradesh, India.

Mobile: +91-897******* .

CAREER Objective:

To maximize the potentials and utilize them effectively to attain organizational

goals and objectives through positive attitude, flexibility and an open mindset. To

enhance knowledge for professional growth in the field of Clinical Research and

elevate to higher achievements in career and procure responsibilities that account

on the basis of performance and diligent work.

Summary:

Having 6 months of experience in the sphere of Clinical trails.

Thorough understanding of Clinical Data Management related activities.

Good Comprehension of FDA, ICH-Good Clinical Practices guidelines and other

regulatory requirements.

Thorough knowledge and expertise in the variety of functions related to Clinical

Data Management includes CDISC guidelines (Clinical Data Interchange Standards

Consortium), 21 CFR Part 11 guidelines, various phases of clinical trials like Phase

I- IV.

Knowledge of clinical Trial data like Demographic Data, Adverse Events (AE), Serious

Adverse Events (SAE), SAE Reconciliation and Laboratory Data (Lab Data).

Educational Qualifications:

PG Diploma in Clinical Research and Clinical Data Management from Global Medical

Education and Research Foundation in 2013.

Master of Science (Biotechnology) 2012 from P.N.C&K.R College of PG Courses,

Narasaraopet, Affliated to Acharya Nagarjuna University, Guntur(Dist).

Bachelor of Science (B.B.C) 2010 from Sri Jeevanjyothi Degree College, Giddalur,

Prakasham (Dist).

Intermediate (Bi.P.C) 2007 from Vijaya Co-Operative Junior College, Giddalur,

Prakasham(Dist).

S.S.C 2005 from S.V.V.S High School, Giddalur, Prakasham (Dist).

Technical skills in Computers:

Application knowledge in MS-Office.

Professional Experience:

Over 6-Months Internship Experience in the field of Clinical Research in Global

Clinical Research Services Pvt. Ltd. in the therapeutic area viz., Cardiology in

Phase-III & IV Studies.

Exposure to Data entry and Discrepancy Management in Clinical Data Management Tools

viz. Inform and RAVE.

Perform site Selection, Initiation, Monitoring and Close-out visits.

In CLinical Operations:

Co-ordination:

Assisting the Principal Investigator during Completion of site feasibilities and

Coordination with Sponsor/Clinical Research Organization.

Prepared and submitted EC dossier as per Regulatory requirements.

Assisting Principal Investigator from the site qualification to Site closeout visit.

Coordinating with Sponsor/ Clinical Research Organizations, Principal Investigator

for the study related procedures & Study issues.

Scheduling Patients visits as per protocol and performing the Study Visits with

Principal Investigator

Performing and confirm the study related activities by Interactive Voice Response

System (IVRS) and Interactive Web Response System (IWRS) for (Subject Visit

Registration, Investigational Product Shipment acknowledgement, etc.)

Shipment of Samples to the local labs and central labs (Covance, Merck etc).

Assists the Monitors during the Site Monitoring Visit.

Identify significant problems and issues and to ensure that all clinical aspects of

studies are being carried out in accordance with the protocol requirements, Standard

Operating procedures and ICH GCP guidelines.

Maintenance of Source Documents, ISF & IP:

Maintaining the Source documents, CRF's, and other study related documents according

to ICH-GCP guidelines and Schedule Y.

Logs, Forms and Reports: Prepared the study specific logs, forms and reports for ISF

and Source Documents.

Maintenance of Investigational Product according to the specific temperature as per

the protocol and conducts IP accountability.

Exposure to CDM Tools:

Completing the Paper and Electronic Case Report Form's.

Having exposure to Inform, Remote Data Capture (RDC), Electronic Data Capture (EDC)

and RAVE electronic Case Report Form's (e-CRF).

Resolution of queries generated by data management.

Safety Reporting:

Coordinate the Serious Adverse Event reporting to sponsor and local regular

authorities with time-lines and as per applicable Regulatory Guide lines.

Trainings and Certifications:

Quintiles ICH GCP for clinical trial sites for online Training & Certification.

CLINICAL TRAils Handled at Global Clinical Research Services Pvt. Ltd.

Cardiology:

Indication

Phase

Status

Coronary

III

Ongoing

project work:

Title: Production and Optimization of fibrinolytic enzyme from bacillus subtilis

species.

Objectives:

Isolation of bacterial strains from soil sample.

Screening of Bacillus species by Bio-Chemical tests like IMVIC test, Fibrinolytic

activity test etc.

Optimization of fibrinolytic protein activity and production by bacillus strain.

Personal skills:

Good interpersonal and communicational skills.

Positive attitude, adaptability to the New Environment.

Working with equal strength individually or as team.

Zeal to learn new things and achieving targets.

Willingness to accept challenges and Ready to face any difficulties.

Personal Details:

Name : D. Raja Shekar Reddy,

Father's Name : D. Ranga Reddy,

Date of Birth : 04-06-1990,

Sex : Male,

Marital Status : Unmarried,

Languages Known: English, Telugu and Hindi.

DECLARATION:

I hereby declare that the information furnished above is true to the best of my

knowledge.

PLACE:

DATE:

(D.Raja Shekar Reddy)

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