Clinical Research Manager
Resume:
Reena Karki
*****.*******@*****.***
Current Address:
Belmont, MA
WORK EXPERIENCE
Senior Research Manager, Boston University School of Medicine, Geriatrics Department May 2019-Present
Responsible for simultaneously leading various on-going studies.
Responsible for developing clinical research methodologies, regulations, and guidelines.
Developing written study plans for multi-center trial—Standard Operating procedures, protocol, Manual of procedures, clinical operations, site selections.
Point person to maintain partnerships with external and internal stakeholders.
Working with research coordinators and investigators to ensure compliance with project standards.
Excellent in troubleshooting recruitment problems, and other study problems
Preparing reports for internal and external customers—NIA including division chief, study sponsors and collaborating institutions.
Responsible for managing a team of four study managers, 19 research coordinators, and 8-9 students. Organizing and conducting research team staff meetings, issuing work assignments, assessing and balancing workloads and schedules.
Training and certifying personnels across sites on various study measures.
Reviewing potential projects for “fit” with current infrastructure, funding, and feasibility.
Assisting in planning, designing, and initiating future studies, and assists with grant application activities
Responsible for grant and budget management
Research Manager, University of Utah Department of Pediatric Emergency Medicine June 2017-April 2019
Collaborating with study sponsors and PIs to establish objectives, procedures, and deadlines for each project.
Collaborating with study sponsors, PIs, IRB personnel to develop study specific materials—informed consent, assent forms, recruitment materials, and CRFs.
Overseeing day-to-day clinical research activities, clinical operations to ensure compliance with all study protocols and operational plans
Training research coordinators to Enroll/consent patients for research studies, collect/enter data, and record/document safety issues.
Overseeing development and maintenance of database systems for all research projects—data collection, query resolution, data quality.
Preparing reports and assisting in manuscripts for project investigators, study sponsors and collaborating institutions.
Overseeing IRB and other regulatory processes, including continuing education for research personnel, and ensuring compliance with good clinical research standards and practices.
Organizing and conducting research team staff meetings, issuing work assignments, assessing and balancing workloads and schedules; overseeing and participating in on-call responsibilities and assignments.
Providing study-specific education and training for faculty, fellows, hospital clinical and ancillary staff, and students.
Collaborating with division manager to monitor study expenditures, assists with budget preparation for future studies, and ensures appropriate expenditure of funds.
Regulatory Coordinator, University of Utah Department of Pediatric Emergency Medicine Nov 2015-June 2017
Supervising/training student researchers (ACAs)
Managing different ongoing research studies and study related data
Preparing and submitting IRB applications for single site or multi central studies
Preparing and submitting IRB amendments, continuing review, tracking and reporting AE/SAE
Maintenance of various databases with information related to subject enrollment.
Enrolling patient on various ongoing studies
Lead Researcher, Brigham Young University, Provo Sept 2013- August 2015
Lead researcher on “Blood biomarkers level, Adiponectin and Leptin in association with Cognitive decline.”
Lead researcher on “Prenatal Nutrition Among Bhutanese Refugees in Utah: An Initial Assessment.”
Trained and supervised undergraduate/graduate BYU students to work on the above studies.
Highly involved in literature searches and writing manuscripts
Nursing Instructor/Supervisor, Trishuli Medical Institute, Nuwakot, Nepal Nov 2011- July 2012
Conducted community health camps—preventing, diagnosis, and treating health problems
Supervised the sophomore year nursing students
Lead tutor for—chronic and infectious disease, fundamentals of nursing
Senior Registered Nurse, Alka Hospital, Kathmandu, Nepal June 2009-June 2011
Supervised ICU nursing personnel
Managed and organized ICU
RESEARCH EXPERIENCE
Lead researcher on “Prenatal Nutrition Among Bhutanese Refugees in Utah: An Initial Assessment.”
Lead researcher on “Prevalence of Controlled and Uncontrolled Hypertension among adults of Southern Central Kentucky.”
Coauthor on “Alcohol privatization and control policy considerations in Utah: A new framework for classifying alcohol policy by retail structure.”
EDUCATION
Brigham Young University, Provo, UT/Master of Public Health, Sep 2013
GPA: 3.9
Awarded MPH Outstanding Student Achievement Award
Goa University, India/Post Graduate Certificate in Clinical Research and Regulatory Management, May 2009
Outstanding grade
Rajiv Gandhi University of Health Sciences, India/Bachelors of Sciences in Nursing, Dec 2008
GPA:3.9 (Grades evaluated by the International Credential Evaluators- WES services)
Achieved GPA distinction upon graduation
SKILLS
Registered Nurse
Certified Clinical Research Coordinator (ACRP Certified)
Statistical Program: SAS
ArcGIS, RedCap, CITI, GCP, Filemaker
General Software: Proficient in Microsoft Word, Excel, PowerPoint, Google Drives
Language: Fluent in Hindi, English, Nepali
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