Principal Investigator/ Head-Clinical Operations/Project Manager

CURRICULUM VITAE

CONTACT DETAILS

NAME: Dr Abhijit Baruah Contact: (M) 900*******/988-***-****

DESIGNATION: Principal Investigator/Head-CR ORGANIZATION: Actimus bio

DEPARTMENT: Clinical Research Personnel: ***********@*****.***

CAREER OBJECTIVE

To work in the Challenging and Dynamic Clinical Research World which provides efficiency to learn, grow and explore my Research & Management skills that allow me for upward movement in my career. To seek responsible positions in an organization where opportunities exist for innovate and challenging professionals and achieve the state where world would know me by my name and work. My ambition is to do something extraordinary research work in future for the benefit of humanity.

EDUCATION

Primary Qualification : MBBS at Assam Medical College, Dibrugarh, Assam

Internship : King George Hospital, Andhra Medical College, Vizag

PROFESSIONAL EXPERIENCE

• First Phase: Study Physician at Actimus Bio pvt Ltd, Visakhapatnam, monitored more than 50 BA/BE studies.

• Second Phase : Medical Investigator at Actimus Bio pvt Ltd, Visakhapatnam conducted and monitored more than 50 BA/BE studies

• Third Phase: Principal Investigator/Clinical Investigator at Actimus Bio pvt Ltd, Visakhapatnam conducted and monitored > 50 BA/BE studies.

• Overall experience 4Years in CRO Industry & more than 350 BA/BE studies(Pilot /Pivotal )

• Presently working as : Head – Clinical research /Principal Investigator

PRESENT JOB RESPONSIBILITIES /PRINCIPAL DUTIES

THE DEPARTMENT – CLINICAL RESEARCH UNIT (CR)

CR is a part of the contract research organization, and the work involves planning, execution and completion of clinical trails. This department is responsible for conducting, documenting and reporting the trial documents to the management

ROLE AS PRINCIPAL INVESTIGATOR/ HEAD –CR

• Responsible for all functions related to CR, like ethical and safe conduct of the clinical studies

• Planning & execution of clinical studies as per all applicable regulatory requirements, GCP and as per the approved quality system procedures and standard operating procedures of Actimus Biosciences Private Limited

• Making medical decision during check-in, housing, check-out and in emergencies.

• Co-ordinating with team members and with cross functional teams to arrange all necessary resources for conducting the studies in an effective manner.

• communicating to the Business Development department regarding the slots and project management related to Clinical studies

• Responsible for ensuring the required qualification, experience, technical competency and training of the all study personnel

• Timely review of all clinical and laboratory data, reading and interpreting clinical reports

• Preparing study documents and assisting the Quality assurance unit in regulatory authorities during audits.

• To be a member of study team, when applicable, and be responsible for initiation, monitoring and termination of tasks during the study process, according to company policies, Sops and regulatory requirement.

• Co-ordinating and being responsible for the review and compilation of study documents such as CRF, study participation cards.

• Volunteers screening, selection and related documentations

• Attending IRB meetings to present the Protocol, study related information to IRB.

• Protocol preparation (Drafting) and review of Protocol, Protocol training to the staff.

• Adverse event monitoring/Medication if necessary, Sponsor communication in case of adverse event.

• Overall conduct of the study as per protocol.

• Final report review/preparation.

• Guiding phlebotomist during procedure.

• Making decision regarding the study in case of any emergency.

• Providing study centers with support and assistance on study specific matters and practical project duties.

• Being responsible for co-ordinating the handling of medication for the projects assisting our Bio metrics unit in its clean file work.

• Reporting to Study Director on clinical study related activities.

• Co-ordinating Clinical study related activities along with fellow Investigator’s or Co-Investigator’s

IN HOUSE AND EXTERNAL TRAINING

• Training on GCP (in house) as per ICHGCP requirements through self study and group discussions.

• Training the CRAs’, Clinical Assistant and Paramedics.

• Trained /Experienced in handling Medical emergencies.

• Trained in Preparing SOPs’, training records, protocols, reports, appraisal forms.

• Trained in facing the clinical step of audits, interacting with Sponsors and Quality assurance personnel.

WORKSHOPS ATTENDED

Participated in the workshop on “Foundations of Clinical Research & GCP” conducted by the “Academy for Clinical Excellence (ACE)”.

Participated in the workshop on “Power of Unity” conducted at the BA/BE facility of “Actimus Biosciences”.

Participated in the workshop on “Time Management” conducted at the BA/BE facility of “Actimus Biosciences”.

Participated in the workshop on “Fire Safety Training” conducted at the BA/BE facility of “Actimus Biosciences”.

Participated in the workshop on “Creativity and Problem Solving” conducted at the BA/BE facility of “Actimus Biosciences”.

Trained in all SOP’s to conduct the BA/BE studies to comply with regulatory requirements and all the GCP guidelines.

PREVIOUS WORK EXPERIENCE

May04 – Feb 06

As a Casualty Medical Officer at Apollo Hospital.Vizag

Dec 03- May 04 As Intensive care unit(ICU) Medical officer in Seven Hills

Hospital, vizag.

ORGANIZATION AND MANAGEMENT SKILLS

I organized voluntary medical camps in rural parts of India where medical facilities are not available.

I organized and conducted college cultural activities.

SKILLS

Trained in Basic Life support

In handling critically ill patient and have the experience of using Defibrillator, suction apparatus etc

as well as managing accident patient.

Independent

IV Line Insertion, Venepuncture, ABG sampling, NG Tube, Foleys Catheter Insertions, Splinting

of fractured limbs and Suturing.

Under Supervision

Lumbar Puncture, Central line access, Chest Drain Insertion

EXPERIENCE WITH COMPUTERS

• Have an average speed on keyboard.

• Familiar in working with WIN 98,2000pro,xp

• Can prepare documents using MS word, Excel

• Competent in Internet surfing and emailing.

SEMINARS AND PRESENTATIONS

• Oct 2001: Presented a Seminar on Type _2 Hypersensitivity at ‘Path2002’ Conference held at Assam Medical College.

• May 2002: Presented a seminar on “Myocardial Infarction and Life style changes “at Assam Medical College.

I participated in many seminars during my Final year of Medical education.

TEACHING EXPERIENCE

• Jan 2003 to Oct 2003: I used to teach methods of clinical examinations and procedures to undergraduates. This was a part of the compulsory teaching sessions to be given by House surgeon to the Undergraduates.

• Jun 2005 to Dec 2005: I conducted teaching sessions held in Apollo Hospital for PLAB 2 Exam.

PERSONAL ATTRIBUTES

Clinical Knowledge and Expertise

• Experience in various clinical fields

• Sound clinical knowledge and view to full investigation of problems

• Treatment and Referral as appropriate

Communication Skills

• Able to build effective rapport and trust

• Multilingual and Multicultural.

Empathy and Sensitivity

• Can empathise with patients/families and colleagues

• Can connect with patients at a personal/individual level

Conceptual Thinking and Problem-solving • Motivated to get to the root of problems despite difficulties

• Ability to use and receptive to different modes of thinking

• Can manage difficult and complex situations

Professional Integrity • Always accept responsibility for my own decisions

• Credit and accept individual contributions/needs

Insight • Aware of my limitations and seek assistance appropriately

• Ability to recognise and cope with stressful situations

Coping with Pressure

• Calm under pressure

• Able to develop appropriate coping mechanisms

• Able to diffuse situations of anger and violence

Personal Organisation/ Administration Skills • Organise information in a structured and planned manner

• Prioritise and delegate

• Good Time Keeping and effective I.T Skills

• Always keep myself abreast of current practices

LANGUAGE KNOWN

English, Hindi, Assamese and Telugu

LIST OF COMPLETED RESEARCH PROJECTS

CLIENTS: DR REDDY’S/MATRIX/STRIDES ARCOLAB/INTELLIPHARMACEUTICS/LUPIN/PANACEA/HETERO DRUGS LTD

LOCATION: ACTIMUS BIOSCIENCES PRIVATE LIMITED, VISAKHAPATNAM

1. Anti-Ulcer

1. Omeprazole 20mg DR capsules

2. Esomeprazole base 40mg DR tablets

3. Pantoprazole Sodium 40mg DR tablets

4. Cinitapride 1mg tablets

5. Omeprazole 30 mg tablets

2. Anti-hypertensive Drugs

1. Atorvastatin Calcium 80mg tablets

2. Amlodipine besylate/Olmesartan medoxomil 10/40mg tablets (Calcium channel blocker + Angiotensin II Receptor Antagonist)

3. Nifedipine 60mg ER tablets (Calcium channel blocker)

4. Irbesartan 300mg +Hydrochlorothiazide 12.5mg (Angiotensin II Receptor Antagonist

+Thiazide diuretics)

5. Carvedilol phosphate 80mg ER capsules (Non- specific β blocker)

6. Propranolol HCl 160mg capsules (Non- specific β blocker)

7. Telmisartan 80mg & Hydrochlorothiazide 12.5mg tablets (Angiotensin II Receptor

Antagonist +Thiazide diuretics)

8. Valsartan 160mg tablets (Angiotensin II Receptor Antagonist)

9. Irbesartan 300mg tablets (Angiotensin II Receptor Antagonist)

10. Moxonidine 0.4mg tablets (Calcium channel blocker)

11. Lercanidipine HCl 20mg tablets

12. Dipyridamole (drug that inhibits thrombus formation)

13. Losartan potassium tablets 100mg

14. Eprosartan Mesylate 600 mg Tablets

3. Anti-Asthmatics

1. Zafrilukast 20mg tablet

4. NSAID + Anti-Histamine

1. Ibuprofen +Diphenhydramine Citrate 200mg/38mg caplets

2. Acetyl Salicylic Acid 650mg ER tablets

5. Anti-Retroviral Drug

1. Didanosine DR capsules 400mg

2. Lamivudine 150mg and Stavudine 30mg tablets

3. Tenofovir Disoproxil Fumarate 300mg tablets

4. Abacavir Sulphate 300mg tablets

5. Lopinavir and Ritonavir 200/50mg tablets

6. Stavudine 30mg+ Lamivudine 150mg+Nevirapine 200mg tablets

7. Emtricitabine and Tenofovir Disoproxil Fumarate 200/300mg tablets

8. Lamivudine 150mg+ Zidovudine 300mg +Nevirapine 200mg tablets

9. Lopinavir and Ritonavir 200/50mg tablets

6. Analgesics

1. Indomethacin ER capsules 75mg (NSAIDs)

2. Etoricoxib 60mg+Paracetamol 500mg tablets

7. Anti-Histamine

1. Levocetrizine dihydrochloride 5mg tablets

8. Anti-Hyperlipidemic Agents

1. Simvastatin 80mg tablets

2. Atorvastatin Calcium 80mg tablets

3. Rosuvastatin Calcium 40 mg tablets

4. Niacin Extended-Release / Lovastatin Tablets 1000 mg / 40 mg

9. Anti-Depressant

1. Paroxetine HCl 37.5mg tablets (serotonin-nor epinephrine reuptake inhibitor (SNRI))

2. Duloxetine HCl 60mg capsules (serotonin-nor epinephrine reuptake inhibitor (SNRI))

3. Eszopiclone 3mg tablets (Sedative hypnotic)

4. Zolmitriptan 5mg tablets (selective serotonin receptor agonist)

5. Atomoxetine (selective nor epinephrine reuptake inhibitor used in ADHD)

10. Appetite Suppressant

1 Sibutramine HCl Monohydrate 15mg capsules

11. Immunosuppressant

1. Mycophenolate mofetil 250mg

2. Sirolimus 2mg tablets

12. Antipsychotic Drug

1. Levosulpride 100mg tablets

13. Anti-Hyperglycemic

1. Glimepiride 2mg and Metformin HCl 1000mg ER tablets

14. Psychotropic Agent

1. Quetiapine Fumarate 400mg ER tablets

15. Biophosphonate Combination

1.Alendronate Sodium 70mg tablets

16 .Anti-Bacterial

1.Levofloxacin 250mg and ornidazole 500mg tablets

2.Metronidazole ER 750mg tablets

3.Balofloxacin 100 mg tablets

17. Others :

1.Sildenafil citrate 100mg tablets (CGMP Inhibitor, used in erectile dysfunction)

2. Paricalcitol Capsules 4mcg (synthetically manufactured analog of calcitriol)

3. Alfuzosin HCl ER 10mg + Dutasteride 0.5mg tablets (used in benign prostatic

hyperplasia (BPH))

4. Tolterodine Tartrate 4mg+Tamsulosine HCl 0.4mg capsules (Muscarnic Antagonist+α1 Adrenoceptar Antagonist)

5. Acamprosate calcium DR tablets 333mg (Used in alcohol Abstinence)

6. Atovaquone 250 mg and Proguanil Hydrochloride 100 mg Tablets (Anti-Malarial)

7. Levetiracetam 1000 mg SR Tablets (Anti-epileptic)

Dr Abhijit Baruah

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