NAME: PRITHA PAL

CONTACT

PHONE: 896*******

EMAIL: adh3dm@r.postjobfree.com

LinkedIn: www.linkedin.com/in/pritha-pal-

b91405175/

EDUCATION, PROFESSIONAL

COURSES & CERTIFICATIONS:

• M.Sc Microbiology from

University of Calcutta securing

first class in session 2014-2016

• Currently pursuing Post Graduate

Diploma in Clinical Research in

Regulatory Affairs from Jadavpur

University (session2019-20).

• ICH-GCP certification

ACADEMIC PROJECTS:

• Coursework in cell cultures and

ELISA technique during a

summer project on the topic

titled “Effect of heat killed

Leishmania donovani UR6 &

BCG in exosome upon murine

peritoneal macrophage

functioning” for a duration of

six months.

• Dissertation: “A study on

clinicomicrobiological profile of

diabetic foot ulcer and its

antibiotic susceptibility pattern

among the opd patients

attending the endocrinology

department of calcutta medical

college” for a duration of one

year, Department of

Pharmacology, Medical

CURRICULUM VITAE

PROFILE Enthusiastic clinical research professional eager to contribute to team success through hard work, attention to detail with clear understanding of conducting phase-I, phase-II, phase-III, phase IV clinical trials and able to demonstrate the critical elements of GCPs and federal regulations as it relates to clinical operations, IEC/IRB and Investigator, Sponsor & CRO responsibilities having excellent organizational skills, motivated to learn, grow and excel in contract research organizations, pharmaceutical companies, hospital academic departments and clinical trial sites to utilize my knowledge, skills, and abilities in the field of clinical research. WORK EXPERIENCE

Clinical Trial Assistant at Medclin Research Pvt Ltd, Kolkata from 12th October 2019 to present.

Details of the Studies handled at present company:

• Multicentric, Phase IV, randomized, double blind, placebo controlled trial to assess effectiveness and safety of Lactobacillus acidophilus LA-5® and Bifidobacterium BB-12® in the treatment of Non-Constipated Irritable Bowel Syndrome in adults aged 18 years to 65 years Investigational Product: Providac

• A Prospective, Randomized, Three Arm, Open Label, Parallel Group, Multicentric Study to Evaluate the Effectiveness of Supplementing MG- HT® in Reduction of Blood Pressure in Subjects with Stage I – Stage II Hypertension on any Anti-Hypertensive Therapy

Investigational Product: MG-HT

• Evaluation of Pertussis in young infants in India (Multicentric surveillance study)

• Effectiveness and Safety of Cefditoren Pivoxil in Childhood Acute Respiratory Tract Infection: A Prospective, Open Label, Single Arm, Unicentric, Phase IV (Post Marketing) Study in India Investigational Product: Cefditoren Pivoxil

• A Prospective, Multicentric, Randomized, Open Label, Active Controlled Trial to Evaluate the Efficacy And Safety Of Sucralfate Administered Concomitant to a PPI Versus PPI alone in Gastro Esophageal Reflux Disorder

Investigational Product: Sucralfate

• A Prospective, Multi-Centric, Randomized, Double Blind, Placebo- Controlled Study to Evaluate the Effectiveness of Supplementation of Nefrosave® in Preventing Progression of Chronic Kidney Disease Investigational Product: Nefrosave®

Work history in the present company:

· Performed Site Feasibility Visits, Site Selection Visits

· Dossier preparation and supporting document submission for E.C committee review meeting and approval

2

College, College Street,

Kolkata . (Performed microbial

assay of antibiotics and

various biochemical tests for

screening of microorganisms)

SKILLS:

· Performed Site Initiation Visit

· Given Protocol training to P.I and site representatives

. Performed Life cycle management of the studies

· Monitored data expeditiously to reduce data discrepancies; collaborated with both the sites and data management department.

· Facilitated escalation processes for elevating site or study issues in clinical monitoring with monitored reports for study site personnel and team members.

· Frequent communication with P.I, Site Representative, Sponsor Representatives

· Functioned as the primary point of contact between sponsor and study sites

· Reviewed lab reports and clinical data; contacted sites and discussed laboratory results and actions necessary to ensure protocol consistency and patient safety.

· Vendor Communication and management · Budget and contract development for sites, vendors

· Managed Study Financials

· Assisted in Authoring SOPs and authored Lab Manual

· Assisted in QMS preparation as per ISO guidelines for ISO-9001 registration of the company.

. Devoted special emphasis to punctuality and worked to maintain outstanding attendance record, consistently arriving to work ready to start immediately.

. Resolved logistic and physical visit problems of enrolled subjects, improved operations and provided exceptional client support during lockdown for COVID-19

. Performed budget negotiation with vendors to comply with the sponsored study budgets.

PROFICIENCIES:

• Knowledge of and ability to adhere to good clinical practices (GCP).

• Appropriate knowledge of conducting phase-I, phase-II, phase-III clinical trials and other therapeutic knowledge related studies

• Preparation of regulatory submissions and supporting documents for IRB review IRB review, DCGI and Sponsor records.

• Strong experience with EDC systems, Clinical data management skills to create and update study documents (i.e. CRFs, eCRFs, ICFs, HIPAA etc) to ensure regulatory compliance.

• Creating documents and reports for A.E, S.A.E, Unanticipated problems according to Clinical research organization policy, Sponsor, IRB, FDA, ICH GCP guidelines, NDCT rules and specific protocol.

• Highly organized with attention to detail and knowledge of scientific, medical, and regulatory terms of Regulatory Authorities like CDSCO, ICMR, FSSAI, FDA, European, Anvisa, MHLW, etc.

ADDITIONAL INFORMATION:

• Languages Known: English, Hindi, Bengali

• Additional Qualities: Trained Bharatnatyam dancer with degree certificates from Pracheen Kala Kendra, and presently learning other Indian classical dances and western ballet forms.

• Freelance content writer and educator having own website: www.ekofeatlearning.co.in

• Refferences : Dr. Sangeeta Agarwal (Course Coordinator- Clinical Research

& Regulatory Affairs, Bioequivalence Study Centre, Jadavpur University) Phone no.- 798*******

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GCP

Patient Recruitment

Trial Study Center Set up

Trial Methodologies

Patient Safety

Regulatory Compliance

Project Management

Project Monitoring

Data Collection

Reporting Writing

Cordinating Site

Operations

NDAs

Subject Tracking Tool

Process Improvement

Budgets

Supervision

Problem Resolution

Contact this candidate