Clinical Research Program Manager
Resume:
Groveland, MA *****
Cell: 978-***-****
E-mail: ****.*****@*******.***
John Garfi
Work Experience:
ORTHOPAEDICS, LAHEY HOSPITAL AND MEDICAL CENTER. BURLINGTON, MA
RESEARCH PROGRAM MANAGER, May 2019 to December 2023
CLINICAL RESEARCH SPECIALIST, April 2008 to May 2019,
40 hours per week
Promoted to Research Program Manager in May 2019 to better define my role and responsibilities.
Direct Management of a research assistant, database coordinator, and visiting students.
Taught clinical research, statistics, medical, and physiology principles to my team.
Helped research assistants get on abstracts/papers., All got into medical school.
Worked with Primary Investigators to:
Design and implement homegrown studies.
Write and edit protocols for prospective and retrospective studies.
Construct statistical analyses on data and reported results to PIs.
Edit and submit research articles to an appropriate journal.
Write and submit local grant proposals for homegrown studies.
Submit IRB applications, renewals, and amendments, report deviations, AEs, and SAEs.
Develop Excel and REDCap tools for use in data collection for studies.
Get multicenter retrospective trials collected and submitted.
Day-to-day activities of multicenter prospective studies within orthopaedics:
Managed research assistant in issues with their study and guide them to do the job properlly
Collected data, entered data in source documents and CRFs (paper and electronic), answered queries from sponsors while ensuring data integrity.
Assisted the primary investigator (PI) with consents
Collaborated daily with investigators, trial coordinators, and different hospital staff teams within the organization.
Web based data collection:
Took lead on implementing a web-based data collection system for outcome measures using I-Pads (AOPOC & recently REDCap). Workied on integrating and using EPIC tools to do the collection of patient reported outcomes.
Trained staff on how to use the tool properly for patients to do their surveys.
Designed and used REDCap collection tools to be used for our future and current retrospective and prospective trials.
Worked on research projects using the ACS National Surgical Quality Improvement Program (NISQIP) database. receiving the dataset, cleaning data, and running appropriate statistics for projects. H
ad an abstract accepted for a talk at a national orthopaedic meeting.
Other Activities:
Set up and managed a computerized temperature probe system for a project on cadaveric legs with external fixators in an MRI. Analyzed data and reported results to the team. This project was presented at two national orthopaedic meetings and was published in an orthopaedic journal.
Wrote protocol and did data analysis on QA project looking at a novel way (BINDEX Vs. DXA) of measuring bone density for our fragility clinic.
EAST COAST CLINICAL RESEARCH, HAVERHILL, MA
CLINICAL RESEARCH COORDINATOR, May 2007 to March 2008, 40 hours per week
Day-to-day activities of various pharmaceutical (phase 1-3) sponsored studies:
Studies involved with were diabetes, cholesterol, and an acne trial.
Recruited subjects, telephone screening, obtaining consent, scheduling visits, filling outsource documentation and case report forms (hard copy & electronic), instruction and administration of study medications.
Collected study related tests.
Other Activities:
Created a central file server for an eight-station computer network.
Developed template documents in Word and Excel for research projects.
Implemented and created for a successful phase 1 trial at a local hospital.
ANDROGEN CLINICAL RESEARCH UNIT, ENDOCRINOLOGY, BOSTON MEDICAL CENTER, BOSTON, MA
CLINICAL RESEARCH COORDINATOR, July 2005-May 2007, 40 hours per week
Day-to-day activities of an NIH-sponsored study:
Recruitment. telephone screening, interviewing, and scheduling of subjects.
Obtained subject’s medical history, and laboratory data for eligibility.
Monitored subjects for health issues, psychosocial issues, and adverse events.
Had experience with gathering sensitive patient information.
Data collection and management,
Assisted PIs in writing IRB amendments, deviations, AEs, SAEs. Involved in filling out and submitting further regulatory documents such as 1572s.
Wrote and implemented the case report forms and survey tools for this study.
Other Activities:
Finding and ordering supplies needed for the study.
Worked on the design and implementation of the main database.
Developed Excel and Access tools for numerous studies.
Designed and implemented a video tool used during the study.
CARDIOLOGY, SPAULDING REHABILITATION HOSPITAL, BOSTON, MA.
EXERCISE PHYSIOLOGIST, March 2000-June 2005, 40 hours per week
Direct patient care of cardiac rehabilitation patients:
Exercise prescription/implementation, the teaching of secondary risk prevention, documenting patient progression, and addressing medical issues.
In charge of finding and purchasing telemetry equipment for the program.
Supervised the ECG technician and Interns,
Other Activities:
Analyzed the 24-hour Holter monitor (ECG) activity and conducted stress testing.
Involved in the teaching of staff including exercise issues with Steroid Myopathy, Heart Transplant and general principles of exercise in the cardiac population.
CRITICAL CARE, BAYSTATE MEDICAL CENTER, SPRINGFIELD, MA
DATABASE COORDINATOR & RESEARCH ASSISTANT, March 1997 – March 2000, 40 hours per week
Ran “Project Impact “critical care database:
Data collection of prospective and retrospective patient charts admitted to a 24-bed ICU.
Data collection included demographics, diagnoses, complications, procedures, and labs.
The data collected was used for internal QA and research. Project Impact tools (outcome models) and external programs were used to analyze and present the data. Also, sent data to a centralized registry.
Other Activities:
Assisted in the collection of blood samples for phase 2/3 clinical trials.
Assisted medical staff with operational research issues including designing data collection forms, databases, and study design.
EMERGENCY MEDICAL TECHNICIAN, 1983 - 1996
Oversaw medical assessment and direct medical care in emergency and non-emergency situations outside of a hospital setting under the direction of emergency staff.
Education:
SPRINGFIELD COLLEGE, Springfield, MA
Master of Sciences in Exercise Physiology, August 1999
SALEM STATE COLLEGE, Salem, MA.
Bachelor of Science in Biology, Minor: Chemistry, May 1991
NORTHERN ESSEX COMMUNITY COLLEGE, Haverhill, MA.,
Liberal Arts Studies, 1985 – 1987
Emergency Medical Technician Certification. 1982
Computer and Statistical Proficiencies:
Exceptional knowledge of basic hardware and software usage, installation and troubleshooting of IBM compatible computers:
Have over 10 years’ experience using SPSS and MiniTab for the interpretation of research data. These tests and concepts learned and utilized for research include but not limited to:
Descriptive statistics t-tests (independent & paired)
Correlation Regression (Logit, linear & polynomial)
ANOVAs (factorial & repeated measures) Chi-square and Fischer
Logistic Regression
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