Research Assistant Data Entry

Objective and Summary

I am looking for an opportunity in the healthcare/clinical research to make progress both professionally and personally in life by contributing to make this world a better place to live in, one day at time.

My experiences include working as a resident doctor, a duty doctor, volunteer at eldercare, volunteer at hospice, clinical research intern, medical scribe in a Google glass research, Healthcare assistant to OB/GYN.

My educational qualifications include 1) Bachelor of Homeopathic Medicine and Surgery 2) MBA in Healthcare Administration 3) Clinical Trials Design and Management

Work Experience

1)Research Qualifications (Clinical Research Coordinator Assistant)

Efficiently working on multiple studies Phase 2 and 3 to prescreen, recruit & enroll study participants; review patient's record for study eligibility; conduct & document the informed consent process and oversee study enrollment goals and determine effective strategies for recruiting & retaining participants.

Work in collaboration with health care providers to apply study protocol to patient care & follow-up; attend clinic visits for study patients with the physician investigators; review source documents and perform study-related assessments.

March 2022

Group 1: Biochemical Research Investigators & Key Personnel, CITI Program

Group 7: Good Clinical Practice, CITI Program

Dangerous Goods, Mayo Clinic

Transporting Goods, Mayo Clinic

C-SSRS Training, The Columbia Lighthouse Project

Clinical Research Studies Currently working on

March 2022 — Present: Clinical Research Assistant, Biohaven Pharmaceuticals, Inc, A Phase III, multicenter, randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder

March 2022 — Present: Clinical Research Assistant, Biohaven Pharmaceuticals, Inc, A Phase II, multicenter, 48-week Open-Label Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder.

March 2022 — Present: Clinical Research Assistant, Vanda Pharmaceuticals, Inc, A Phase III, multicenter, 12-week Open-Label Safety Study of Adjunctive Tasimelton in Subjects with Autism Spectrum Disorder.

March 2022 — Present: Clinical Research Assistant, Blackthorn Therapeutics, Inc, A Phase IIA, Randomized, Double-blind, Placebo-controlled Proof of Concept Study to Evaluate the Effects of Oral BTRX-335140 Versus Placebo in Subjects with Major Depressive Disorder

March 2022 — Present: Clinical Research Assistant, Vanda Pharmaceuticals, Inc, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vqw-765 In Patients with Performance Anxiety

March 2022 — Present: Clinical Research Assistant, Siemens Healthcare Diagnostics, Adolescent Reference Interval Sample Collection for AMH Repository

March 2022 – Present: Clinical Research Assistant, Siemens Healthcare Diagnostics, Adult Reference Interval Sample Collection for AMH Repository.

March 2022—Present: Clinical Research Assistant, AbbVie Inc., A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine with or Without Aura in Children and Adolescents (Ages 6-17)

March 2022—Present: Clinical Research Assistant, AbbVie Inc., A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine with or Without Aura in Children and Adolescents (Ages 6-17)

March 2022—Present: Clinical Research Assistant, Vista Gen Therapeutics Inc., A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of PH94B Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects with Social Anxiety Disorder (PaliSADe-1)

March 2022—Present: Clinical Research Assistant, Vista Gen Therapeutics Inc., A Phase 3 Open-label Safety Trial of PH94B Nasal Spray in the Acute Treatment of Anxiety in Adult Subjects with Social Anxiety Disorder (SAD)

March 2022—Present: Clinical Research Assistant, Honeybrains Biotech, Safety and Efficacy of HB-1 for panic disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Duties

1)Coordinates participant site visits and responsible for smooth workflow throughout participant visit. Facilitates the consent process, vitals, physical assessments, ECG's and more as directed by sponsor.

2) Submits eCRF’s into the EDC for documentation and data collection. Determine eligibility of and gather consent from study participants according to protocol.

3)Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Manage data/oversee data management for research projects.

4)Conduct subject evaluation, screening and recruitment adhering to safety and compliance issues. Once recruited, coordinate subject visits, .

Maintain subject binders,

5)Discuss study protocol with patients and verify the informed consent documentation. Provide patients with written communication of their participation.

6)Dispenses study medication in professional and accountable manner following protocol requirements.

7)Complete visit procedures basic/general. Collect study related data and complete study electronic or paper case report forms.

8)Assisted with screening the patients for eligibility, informed consent process, preparing research kits for study visits.

9)Assisted with preparing the regulatory binder, patient site binder. Do physical examination as needed.

10)Screen all lab results when received and follow protocol procedure regarding abnormal results. Adhere to research SOP’S. Adhere to GCP and study protocols.

11)Conduct data collection activities or interviews with participant as directed. Complete case report forms. Perform quality assurance checks for study data, enter study data into IBM database.

12)Ensure scientific integrity of data and protects right, safety, wellbeing of patients enrolled in the clinical trails

13)Conducts detailed data entry of data and patient information, including demographics and symptoms surveys into electronic system in accordance to HIPPA policies. Assist clinical team with collection of medical records and other logistical items.

14)Working under general supervision of research manager and working directly with PI and

15) Create and maintain investigator site files including periodic review for accuracy and completeness

16) ICF process, trail max training and performing study procedures as required for onsite patient and following up with patients through phone calls.

17)Establish and maintain interpersonal relationships with patients, visitors and other hospital personnel, while assuring confidentiality of patient information.

18) Complete study documents/case report forms.

19) Ensure compliance with research protocols, and review report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure Institutional Review Board renewals are completed.

20) Experience working in IBM clinical development, Medidata, Medrio.

21)Used clinical ink tab to collect data from patient.

22)Have mental health experience aware of psych sales.

23)Filing approved documents from IRB to investigation site file.

2)Healthcare Office Assistant - Pacific Women's Healthcare Associates El CAMINO HOSPITAL in OBG dept. – Aug 2016 to Dec 2016

Assist the directing clinician with their documentation in the electronic health record.

Document chief complaint, review of systems, past medical and surgical histories, social history, and discharge and follow up instructions for the encounter and vital signs in the EHR.

3)Medical scribe – Augmedix – Apr 2016 to June 2016

Scribing remotely for multiple out-of-state physicians using Google Glass technology.

Training newer documentation specialists.

Developing proficiency in medical terminology and patient charting.

4)Clinical Affairs Intern – ZOLL Medical Circulation Inc – Aug 2015 to Apr 2016

Knowledge of drug development process, FDA regulations, HIPPA, IRB, medical terminology and ICH-GCP guidelines.

Experience in data entry. Data entry, cleansing and formatting from case report forms collected from clinical sites after studying protocol.

Assisting in reviewing adverse events, death and device malfunction in Clindex.

Assisting in verification of payments to the sites through Clindex.

Experience in user interface testing of Clindex EDC.

Handling test site documents such as CTA, contracts etc. in Clindex.

Assisting in medical device inventory and ongoing clinical trials report for meetings.

Assisting in the preparation of templates, binders and presentation, study-specific training materials.

Work with data manager and bio-statistician.

Assisted project manager in organizing investigators meeting for physicians and sponsors

5)Volunteer administrative Assistant at Heartland Hospice Care March 2015 – May 2015) 3 months

Assist office support work such scanning documents, entering patient information, preparing binders etc.

6)Volunteer Eldercare Services at United Methodist Church – Day Break Care – Oct 2014 - March15): 6 months

Assessed and evaluated elderly participants’ physical, cognitive, social, emotional and functional levels.

Interacted with family members of participants and healthcare team such as nurses to determine the best recovery program for each participant

7)Worked as a Resident Doctor at college Hospital (2011-12 India): 12 months

Responsibilities handled as intern doctor:

Assist to collect, record and track documents, consents, signature approval, agreements, surveys, follow-up and other study documentation and ensure that patient information which is collected is complete

Worked in laboratory, hospital and clinical settings.

Evaluating patient status for safety and assure optimum health care.

Participate in Health Camps conducted in the villages (for 5 - 10 days every month)

Patient data collection, reporting, analysis and maintenance.

8)Worked as Duty Doctor at Spandana Hospital (2011-12 India): 6 months

Assisting case doctor.

Regular visits to the patient ward.

Checking vitals and follow-up.

Assisting with administration of medicine.

Education

1) MBA with concentration on Healthcare Administration in USA.

International Technological University, Master of Business Administration (M.B.A.), Healthcare Management, 3.85 GPA 2014 – 2016

Curriculum: Regulatory overview of new drug, organizational leadership, Mental Health and Wellbeing, Health Information and Communication, Translating Biomedical Innovation from the Lab to the Marketplace, Business Ethics, HR Management, Supplier/Seller Management, International Marketing and healthcare environment.

Project: Spectra T core, January 2015: Designed and developed spectra photometer called "Spectra T Core" and the main objective was to make portable and handy spectrophotometer, which was made in a pen form.

2) Bachelor of Homeopathic Medicine and Surgery

Rajiv Gandhi University of Health Sciences, Dr. B. D. Jatti Homoeopathic Medical College – 2012, India.

Curriculum: Anatomy, Physiology & Biochemistry, Pathology, Social & Preventive Medicine, Forensic Anatomy, Physiology Biochemistry, Pathology, Social & Preventive Medicine, Forensic Medicine, Obstetrics & Gynecology, Surgery & ENT, Ophthalmology, and Practice of Medicine.

3) Certificate: Clinical Trials Design and Management at UCSC SVE (Dec 2017 – Dec 2020)

Curriculum: Drug Development Process, Regulation of Medical Devices and Diagnostics, Clinical Statistics for Non-Statisticians, Document Preparation: Protocols, Reports, Summaries, Good Clinical Practices, Clinical Data Management, Clinical Trials Site Monitoring, Clinical Trials, Regulatory Affairs, and Medical Device Information Session, Drug Safety and Adverse Events Reporting and Science of Clinical Trials Design.

Awards and Recognition

Recognition at Heartland Hospice as “End-Of-Care-Life Champion” for enriching the lives of hospice patients on the National Volunteer Week – 2015

References: will be provided on request.

Thank you,

Manjula Pawar

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