- 8496 Donna Ln Ÿ Xxxxxx, XXXXXX xxxxxx ( (xxx-xxx-xxxx * abc@xyz.com

Clinical Research Management /Administration

Qualifications Profile

    Self-assured, dynamic, and results-driven professional with more than 8 years providing high-performance clinical research and data management, customer service and operations support mostly in the healthcare industry.

-    Proven dedication to process efficiencies in capturing, analyzing, and presenting accurate clinical data for decision makers in arriving at the right intervention plans and research findings that benefit practitioners and patients in the healthcare industry.

-    Detail-oriented, analytical and methodical with critical thinking to resolve data management and clinical research issues even under stress.

    Flexible and adaptable with quick learning abilities to reach high productivity levels in fast-paced work environments.

    Well-organized and resourceful with multitasking skills that optimize limited resources to achieve outstanding results.

    Strong people management and interpersonal communication skills that inspire customer confidence while forging teamwork synergies with colleagues across diverse ethnicities.

Key Expertise

Operations Management

    Research Operations Planning

    Marketing Campaign Support

    Research Budget Management

    Technical Service Support

    Relationship Management (Clients, Public, & Suppliers)

    Process/Workflow Improvement

    Productivity Improvement

    Project/Program Development

Administration

    Policies & Regulatory Compliance

    Staff Supervision & Training

    Office & Staff Administration

    Records & Document Management

Technical

    Apps: SAS, & RedCap

    Productivity Tools: MS Office (Word, Excel, PowerPoint, Access, & Outlook)

Professional Experience

Data Management

    Manage the desensitization program at The Christ Hospital, administering 11 databases, developing and implementing electronic database capturing systems for phases 2-4 studies (kidney, liver, bariatric, and metabolic), and querying the main transplant database to generate descriptive statistics using SAS.

    Assist in protocol development, entering data into the eCRFs and the main transplant database, generating tables and graphs for newsletters and other study related documents, and assisting the Pharm.Ds and Doctors in content management of publications, abstracts, and other deliverables.

    Monitor investigator initiated studies, 7 sites nationwide, monitors 6 studies (pre kidney transplant, post kidney transplant, liver, & bariatric and metabolic).

    Assist sponsor/IRB with audits and monitoring, conducting on-site and remote monitoring visits, organizing SQV/SIV for outside and internal sites, and liaising between sites, principal investigator, & sponsors.

HR Support and Staff Development

    Provide HR support in staff recruitment, interviewing candidates for employment.

    Train coordinators on study protocols, and regulatory requirements internally and externally.

    Provide training and tools that enable the study team members and transplant team to achieve study objectives.

Compliance Management

    Develop and maintain SOPs for remote and onsite monitoring for the University of Xxxxxx and The Christ Hospital, preparing and routing applications, annual reports, and adverse events to the FDA.

    Track SAEs for INDs for investigator-initiated multi center trials, coordinating all aspects of safety reporting (i.e. IR, FDA, Investigator, and CRC).

    Assist PI in executing protocol modifications in accordance with Federal regulations, University and the sponsoring agency, completing study documentation in accordance with sponsor requirements and University polies (i.e., consent forms, enrollment logs, source documents, narrative notes, CRFs and drug/device accountability logs).

Operations Management Support

    Work with the PI to manage the day to day activities of the study including problem solving, communication and protocol management while developing risk mitigation strategies to ensure successful delivery of study goals

    Participate in defense bid meetings with the director of research.

    Communicate with study vendors to assure that site staff and members of the project team and given access to the appropriate systems and portals, including EDC.

    Perform Phlebotomy, Collecting, Processing & Shipping Samples.

- 8496 Donna Ln Ÿ Xxxxxx, XXXXXX xxxxxx ( (xxx-xxx-xxxx * abc@xyz.com

Professional EXPERIENCE (continued)

    Responsible for managing clinical research operations, managing budgets, checking research equipment prices, conducting phlebotomy and electrocardiograms (ECG), taking vitals, and collecting, processing & shipping samples.

    Conducted phases I-IV, General Health, Ulcerative Colitis, Rheumatoid Arthritis, Psoriasis, & Diabetes, entering data on EDC, and attending meetings with CRA and PI.

    Recruited clinical research subjects via phone and emails and developed brochures.

    Ensured compliance with regulatory and industry mandates, while maintaining employees' training & certifications for each specific study.

    Developed and conducted training content on health education, developing operational plans and policies to achieve health education objectives and services, preparing and disseminating relevant course materials, including research reports, and bulletins using visual aids such as films, videotapes, photographs, and posters.

    Developed and executed marketing campaigns to promote a healthy lifestyle or participation in fitness and wellness programs.

    Performed health screenings for diverse clients, administering blood pressure, and finger pricks for Cholestech machines, and educating participants in cholesterol, blood pressure, weight, glucose levels and nutrition.

    Served as a Customer Service Rep and Technician support, travelling to Independent/Assisted living communities across the nation providing support during and after system installations.

    Provided hands-on training to senior citizens in using company services (phone, internet, TV, nurse call).

    Conducted site training to the executive director and employees on procedures and in using the new system.

    Instructed, motivated, and assisted patients in physical exercises/activities, transporting them to and from treatment area, lifting and transferring them according to positioning requirement, and securing them on therapy equipment.

Education & Credentials

    M.S. in Health Economics and Clinical Outcomes Research, XAVIER UNIVERSITY Xxxxxx, XXXXXX (On Going)

    B.S. in Health Science, BALL STATE UNIVERSITY Muncie, IN (2007)

Professional Training & Certifications

    Trained on GCP, EDC, and CRF

    Clinical Research Professional (CCRP)- Society of Clinical Research Associates (2016)

    Clinical Research Associate- Barnett International's (2016)

    Clinical Project Management- Barnett International's (2016)