Clinical Research Data Entry

Mr. Rohit Vijay Chandak

Contact Number-950-***-****. Email **-***.*******@*****.***

Career objective:

To put up the best of me so as to initiate constructive changes for my organization that I would work for to get productive results.

Experience details:

Currently working as a Senior Executive (senior clinical research associate) in Sun Pharma advanced research company limited from Jun 2018 till date

Previously worked as a Clinical research Associate at Cliantha Research Limited: (Dec 2016 to Jun 2018)

Previously worked as Study Start Up associate at ICON PLC: July 2015 to Dec 2016

Previously worked as Clinical research coordinator at JCDC Pune: Apr 2014 to July 2015

Completed 3 months internship working as clinical research coordinator at JCDC

SKILL SET:

Technical Skills:-

HAVING KNOWLEDGE OF ICH-GCP GUIDELINE

SCHEDULE Y

CLINICAL TRIAL

ECRF

BASIC KNOWLEDGE OF CLINICAL DATA MANAGEMENT

Interpersonal Skills:-

Good learner

Capable of working independent and also as a team.

I am adaptive and focused person.

Extra co-curricular activities/achievements:

Participate in BhartiyaChatraSansad in MIT Pune.

Participated in national level conference related to drug discovery process.

Educational details:

Bachelor in Pharmacy from Pune University, in 2013-2014 with aggregate 60%.

Diploma in pharmacy from Anuradha College of pharmacy, chikhli with 66.40%.

Completed post graduate diploma in clinical research and data management,Jehangir

Centre for learning, Pune

Professional Experience:

Organization:

Currently working as a Clinical research Associate at Cliantha Research Limited: (Dec 2016 to Till Date)

Trial Related Experience:

-Critical Document Package Review.

-Site Activation

-IP release.

-Data Entry

- Trained on ICH-GCP, Schedule Y, ICF Process, SAE reporting

- Screening and Enrollment of study subjects.

- Maintaining Site Master Files

- eCRF.

- Interactive Voice Respond System (IVRS) calling.

- Study drug accountability.

- Sample labeling and dispatching.

- AE monitoring, reporting and follow up of study.

- IEC/IRB correspondence including SAE submission, all essential documents.

- Managing all trial activities including site initiation, sponsor visit, auditor visit etc.

-Responsible for monitoring the conduct of clinical research studies.

-visit sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure data collected from start up to termination of studies and to terminate studies.

- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and compliant with applicable local regulatory requirements and ICH guidelines.

-Performs investigative site file reconciliation, requests any new or updated site-related essential

And non-essential documents and reviews them for content, consistency with other documents and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.

Major Project History Projects as a CRC:

1. Phase III-Global- Diffuse Large b-cell lymphoma

2. Phase III- Global – Follicular lymphoma.

3. Phase III- Global- Chronic myeloid lymphoma

4. Phase III- Global – Prostate cancer

5. Phase III-Global- Lung Cancer

6. Phase III-Global-Diabetes mellitus.

7. Phase III-Rheumatoid arthritis

8. Phase III-Hair fall.

9. Phase III-Acne

10 Phase I-Hypovalemic Shock

Major Project History Projects as a CRA

Phase III-Indian-Scabies (Close out stage)

Phase III-Indian-COPD (Copmleted)

Bioequivalence study- Schizophrenia (completed)

Phase I-Asthma (Start up)

Phase III-Lung Cancer (Completed)

Phase I- COPD (Start up)

Phase I-Dengue (Start up)

Number of visits completed till date

Site qualification visits- 70 Visits

Site initiation visits- 25 Visits

Site monitoring visits- 65 Visits

Site Close out visits- 08 Visit

Personal details:

Name : Rohit Chandak.

Date of Birth : 02 Mar 1990.

Father Name : Vijay M. Chandak.

Sex : Male.

Marital Status : Single.

Nationality : Indian.

Languages Known : Marathi, Hindi and English.

Hobbies : Singing, Acting.

Address : Cotton market road, Mali Khel Jalgaon (Jamod) Dist-Buldhana,

Pin Code-443402

Declaration:

I hereby declare that the above written particulars are true to the best of my knowledge and belief.

Place : Mumbai (Rohit Chandak)

Date : 03-Dec-2018

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