Ayarpi Reganyan

BodyBar Protein

BodyBar Protein is a protein bar company in startup. The purpose of this company is to bring better nutrition to on the go protein bars. These great tasting protein bars will be different form other protein bars because they will be Gluten Free, Paleo, with no additives, artificial sugar, not even “natural flavors."

Founder

Syneos Health (Previously INC Research/inVentiv Health)

•	Manage a clinical research study by ensuring compliance with ICH-GCP, relevant SOP’s and 
        regulatory requirements.  
•	Act as a primary point liaison between the Company and the Client to ensure timely study start up, 
        conduct, closeout according to the Client’s and the Company’s contractual agreements. 
•	Ensure project-related training is being conducted as needed for study team members.
•	Oversee the financial performance of each project. 
•	Coordinate activities and deliverables of all study conduct partners and proactively identify and 
        manage issues. 
•	Hold team meetings on a regular basis to provide the team with regular updates from the 
        sponsor.

Project Manager

PAREXEL

Responsibilities include:
•	Identify and evaluate potential risks, in collaboration with project team management and other relevant parties (e.g., Project Management, Quality Management, operational and functional staff). Together with these parties, determine appropriate mitigation measures.
•	Implement additional quality interventions in areas of risk.
•	Provide mentoring, leadership and direction to Senior Project Quality Leads and to Project Quality Leads I and II.
•	Build and maintain successful relationships with clients.
•	Identify process improvement opportunities and champion their implementation as assigned.
•	Participate in SOP and process development as assigned.
•	Maintain an understanding of PAREXEL standard operating procedures that are relevant to the assigned project(s) and of relevant regulations and guidelines.

Senior Project Quality Lead

Responsibilities include:
•	Implemented the standard quality interventions for assigned projects, verified compliance with GxP guidelines/regulations, PAREXEL procedures and requirements and sponsor requirements.
•	Reviewed key project documentation and provided feedback to the project teams.
•	Actively participated in key internal project team meetings and facilitated quality discussions during these meetings.
•	Lead quality-focused meetings and/or discussions
•	Provided quality consultation support to project teams.
•	Provided CAPA support to project teams including classification of issues, consultation on appropriateness of corrective and preventive actions and tracking of CAPAs through resolution.  
•	Provided audit and inspection support for assigned projects, including advising the project team during preparation and conduct of audits and inspections.  Reviewed and provided feedback on project related audit/inspection responses generated by project team members prior to finalization. Represented Operations Quality Management in audits and inspections.
•	Oversaw the collection and reporting of project quality metrics.

Project Quality Lead II

Responsibilities included:
•	Reviewed and understood the study protocol and made clarifications of any protocol issues.
•	Assessed the training needs for the study team and arranged for any additional training needed for study protocol.
•	Provided analysis for study protocol inclusion/exclusion criteria, screening packets, lab requirements, flow sheets and equipment needs.
•	Prepared staffing requirements with the assistance of the Department Managers and/or the Nurse Supervisor.
•	Trained study team members on study rating(s) scale(s) as required and performs rating scales as needed.
•	Ensured basic study participant safety is provided within the clinic for outpatient visits and/or hospital for inpatient study periods.
•	Communicated with physicians and relevant clinical staff ing evaluating study participant status.
•	Ensured all medical equipment (i.e., crash cart, ECG machines, dynamaps, etc.) was functioning properly.
•	Remained on-call to handle all after-hours study participant issues.
•	Hosted pharmaceutical representative visits.
•	Acted as a liaison between Study Team and Quality Management to ensure that Case Report Forms, source documents and patient charts were properly reviewed.
•	Maintained and updates knowledge of Clinical Operating Guidelines and their proper application.

Clinical Research Coordinator

Medizone

Responsibilities included: 
•	Handled all new patient program consultations which included uptake of patient’s medical history.
•	Conducted patient work up which included blood draws, inter-muscular injections and  electrocardiograms. 
•	Conducted inventory and placed orders for supplies.  
•	Regulated all medications in the pharmacy including drug accountability and drug dispensation.

Medical Assistant

Everest College

Responsibilities included: (Part- time/on call Medical Assisting Instructor) 
•	Demonstrated and instructed on all clinical functions such as injections, electrocardiograms, blood draws and vital sign assessments.
•	Maintained a teaching assignment for each module.
•	Instructed the assigned course(s) in accordance with the approved curriculum. 
•	Ensured that the quality and quantity of instruction provided in the classroom is consistent with the stated objectives of the school and industry. 
•	Maintained a daily record of student attendance and grades in accordance with school policy.

Medical Assisting Instructor

Facey Medical Foundation

Responsibilities Included:
•	Conducted patient screening and protocol visits.
•	Reviewed data for accuracy, completed case report forms and resolved quires.  
•	Created marketing material and submitted it into IRB for approval. 
•	Acted as point person for the clinical-study site, overseeing all operational responsibilities. 
•	Performed duties including recruitment, terminations and subject payment requests. 
•	Maintained record of study data.
•	Prepared research documentation for monitor review.
•	Entered data into the EDC.

Medical/ Research Assistant

Ayarpi Reganyan has 10 years of experience in the Contract Research Organization (CRO) Industry as an Associate Project Manager, Clinical Research Coordinator, and Project Quality Lead. There she worked in the different phases of drug development, ranging from First in Human to Phase III trials. Furthermore, Ayarpi Reganyan has three years of experience as a Clinical Research Assistant at an Investigator site.
Ayarpi Reganyan is a Certified Clinical Research Professional with SoCRA since April 2014.
Her therapeutic experience includes Ophthalmology, Oncology, Central Nervous System Diseases and Disorders, Rheumatology, Endocrinology, Gastroenterology, and Device studies.

Currently, Ayarpi Reganyan is also working on launching the BodyBar Protein Company. The goal of this company is to bring better nutrition to on the go protein bars.

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