Research Fellow Coordinator

RESUME

ASHWINI B SHARANNAVAR

Cell: 701-***-****/996-***-****

Email: ***********@*****.***.

Career Objective: Secure a responsible career opportunity to fully utilize my training and skills, while making a significant contribution to the success of the company. Professional Summary:

Core Qualifications:

● Excellent knowledge on ICF, ICH GCP guidelines, ICMR guidelines and SOPs of Clinical Research Site, DCGI rules and regulations.

● Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations.

● In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements, and guidelines.

Experience in sample collection from patients at scheduled time, source template writing and CRF filling and involved in telephonic follow up procedures. Worked with SCEPTRE database, CITRIX.

● Experience in coordinating with the ethics committee, which safeguards the rights, safety, and wellbeing of all trial subjects.

● Coding relevant medical terminology composed descriptive narrative and generated advanced condition queries.

Experienced in organizing all aspects of a Medical/Pharmaceutical research project.

Project Development and Management.

A highly skilled and dynamic Clinical Project Manager with experience both in Clinical Operations and Pharmacovigilance departments. Talents include in-depth knowledge of ICH- GCP guidelines. Integral team-player with excellent communication skills; fluent in English. Bringing a 7-plus-year track record in conducting site visits to assess protocol and regulatory compliance to ensure the quality of clinical trials. Exceptional analytic skills as evidenced by running clinical trials to test drugs for marketability and developing and evaluating trial protocols.

Clinical Data management

Recruitment and screening

Accounts Payable / Receivable

Quality control check of adverse event for accuracy and completeness.

Serious Adverse Event (SAE) reporting.

THERAPEUTIC AREAS:

Good experience in Clinical Research in therapeutic areas like

Oncology,

Dermatology,

Allergy and Immunology,

Diabetology

Nutraceuticals

Ayurvedic Trials

Ophthalmology

Medical Devices

Interested in working in therapeutic areas like

Cardiovascular/ Metabolic.

Neurosciences

Endocrinology and Metabolic Diseases.

Respiratory and Immuno-Inflammatory.

Vaccine, Nephrology and Urology.

EMPLOYEMENT CHRONOLOGY:

EXPERIENCE POSITION ORGANISATION/PLACE

02/2020 to Present Clinical Project Manager Nextvel Consulting LLP Responsibilities:

Handle Clinical Study projects independently and with complete accountability

Accountable for Quality, Time and Budgets for the projects

Preparation of Clinical Trial documents (like Study Protocols, Informed Consent Documents, Case Report Forms, and Investigator’s Brochure etc.) on available templates.

Prepare Clinical Trial Agreements and negotiate budgets with sites

Conduct Study feasibilities

Perform of Pre-study and Post study duties.

Regulatory documents preparation and submission.

Studying scientific documents.

Keeping up to date with changes in regulatory legislation and guidelines.

Providing advice about regulations to manufacturers/scientists.

Ensuring that quality standards are met and submissions meet strict deadlines. EXPERIENCE POSITION ORGANISATION/PLACE

06/2018 to 02/2020 Clinical Project Manager/Sr CRA HCRS, Bangalore Responsibilities:

Managed a Phase III and IV, randomized clinical trial in dermatology therapeutics.

Experienced with start-up and corporate companies adapting to the varying expectations in the respective job environment. With start-up company requiring more individual initiative while corporate companies demanding a professional workstyle.

Acted in a lead role in building the clinical operations department, developing SOPs, work practices and implementing EDC and a CTMS. Responsible for all aspects of the clinical trial start-up including, identification, evaluation and management ofCROs and vendors. Developed and manage the budget, timeline, monitoring schedule and all monitoring activities.

Provided monthly trial status (budget, timeline, recruitment metrics, vendor performance metrics) presentation to upper management.

Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts.

Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc

Proactively identifies and resolves issues and participates in process improvement initiatives as required.

Evaluates monitoring reports with significant findings to confirm appropriate conclusions and actions taken.

PROMOTION: SEP 2018: Promoted from Sr CRA position to Clinical Project Manager. ACHIEVEMENTS:

Developed a strong and talented clinical research Team.

Contributed in 200 % increase of revenue to the company.

Started new therapeutic areas projects like diabetology and nutraceuticals.

Developed new SOP’s for proper functioning of team and for higher accuracy.

Represented the company at professional and trade association meetings. EXPERIENCE POSITION ORGANISATION/PLACE

OCT 2016- MAY 2018 Sr Clinical Research Associate MSCR, Bangalore. Responsibilities:

Demonstrated the ability to multi-task and manage different projects while delivering against aggressive goals.

Effectively communicated project work results and plans to cross-functional teams

Implemented methods for collecting high-quality quantitative and qualitative data,

Evaluated suitability of prospective study candidates and recruited research participants

Traveled 70% - 80% to sites for on-site visits

Monitored Investigator compliance for the reporting of Adverse Events and Serious Adverse Events.

Achievements:

Completed dermatology studies within given timelines and achieved excellent results.

Brought new projects with help of new sponsor contacts and with good communication and managing skills.

Added new techniques and taught research team to adopt it and work more efficiently.

Increased patient pool by 200% by counseling.

EXPERIENCE POSITION ORGANISATION/PLACE

January 2015 – March 2015 Process delivery support 1 QUINTILES/IQVIA Responsibilities:

Perform assigned administrative tasks to support team members with project execution( such tasks include but not limited to running system reports, maintaining minutes of meeting, preparing and distributing status reports, creating and maintaining study documents) and assist in updating and maintaining systems within project timelines and per project plans.

Promoted as Drug Safety Associate

Mar 2015 - Sep 2016 Drug Safety Associate QUINTILES/IQVIA Responsibilities:

Initial receipt, Database searches as necessary. Registry and Triage of incoming cases to determine seriousness for prioritization of daily workflow. Completion of literature searches as necessary.

Completion of case processing (case data entry, labeling, approval numbers, manual coding, and narrative writing) and quality review.

Clarification of unclear or illegible information from the Local Safety Associateor Call Centre and customer communication as per the project requirement.

Discuss source documents, coding conventions and ad-hoc queries with Pharmacovigilance Physician.

Completion of protocol request forms as necessary. Preparation of deviation memo as necessary. Request deletions/Admin edit requests as necessary. Single case unbinding. Other Case processing related activities (e.g. review of consistency checks, reconciliation etc.).

Achievements:

Within a short period of time learnt and performed Quality control check of adverse event for accuracy and completeness.

Worked on QC of case processing and submission guidance in finalized cases from various therapeutic areas.

Trained and mentored peers in case processing methodologies, as per regulations and local SOPs.

EXPERIENCE POSITION ORGANISATION/PLACE

Apr 2013 to Dec 2014 Clinical Research Coordinator SMO Clinical Research Services Bangalore

Responsibilities:

Worked on Oncology Clinical Trials.

Participated in recruiting participants, collecting research data and managing all calendars as related to the project.

Sample collection from patients at scheduled time, source template writing and CRF filling and involved in telephonic follow up procedures.

Handling of excellent electronic medical/research data input, capture, Recording, and Transmission.

Understanding of SAE and AE reporting during Study.

Monitoring of clinical trials in various sites. Promoted as CRA from Apr 2014.

Achievements:

Participated in developing standard operating procedures best practices for the clinical site and to see them that all remain in compliance with local, state and federal regulations.

Participated as a member during audit visit of companies.

Participated in auditing of site during DCGI visit.

EXPERIENCE POSITION ORGANISATION/PLACE

Oct 2010 to Feb 2013 Junior Research Fellow IABT, UAS, Dharwad Responsibilities:

Development of marker free transgenic cotton and pigeon pea using codon optimized cry1ACM and cry1ACM mutant to impart tolerance to helicoverpa.

Finger printing of DMT series tomato plants by using ISSR primers

Hag gene cloning and expression.

Tissue Culture and Cloning.

EDUCATION:

● M Sc Biochemistry from Kuvempu University with an aggregate of 70%.

● B Sc Biotechnology from Karnataka University with an aggregate of 82%.

● ICH GCP certified with 88%.

CERTIFICATION:

CXCI Internal Auditor and quality management systems certificate as per ISO 15189-2012. Strengths:

● Good leadership skills as well as ability to work as part of team.

● Ability to work under stressful conditions.

● Good communication skills and other soft skills.

● Self-confident and self-motivated person.

● Quick learner.

● Reliable, able to integrate and harness every resource in getting the job done, and on time.

● Strong organizational, computer, and problem-solving skills.

Contact this candidate