clinical research project manager chop

Lauren O’Malley, MPH is a Clinical Research Project Manager at Children's Hospital of Philadelphia's Center for Injury Research and Prevention. She is the administrative lead for all projects using the New Jersey Safety and Health Outcomes (NJ-SHO) Data Warehouse to establish the foundation for driving safety among teens and young adults with ADHD and autism spectrum disorders. 

Lauren O’Malley, MPH joined the Center for Injury Research and Prevention at Children's Hospital of Philadelphia (CHOP) in 2019. She is currently working with Dr. Allison Curry on a variety of epidemiologic projects related to traffic safety using the New Jersey Safety and Health Outcomes (NJ-SHO) Data Warehouse. Her main projects focus on developing the NJ-SHO Center for Integrated Data and establishing the foundation for driving safety among teens and young adults with ADHD and autism spectrum disorders. She also works on multiple prospective research studies involving digital health-related teen driver safety, distracted driving, and child passenger safety.

Prior to joining CIRP, Lauren worked in child nutrition research at the University of Pennsylvania. While there, she collaborated with CHOP's Center for Autism Research to test a picky eating intervention. Lauren has an interest in chronic disease and injury prevention, digital health, and health communication.

Education and Training

BS, University of Connecticut (Allied Health Sciences), 2016

MPH, University of Pennsylvania, 2019

Titles and Academic Titles

Clinical Research Program Manager I, Center for Injury Research and Prevention, Children's Hospital of Philadelphia

Contact Information

• Cadence Bowden

Cadence Bowden MSW, MPH

Cadence Bowden is a clinical research project manager at PolicyLab and Clinical Futures at Children’s Hospital of Philadelphia (CHOP). Currently, Ms. Bowden supports research focused on pediatric mental health and suicide prevention. Her work aims to support medical hospitals to improve suicide care and implement best practices. She has extensive experience with qualitative data collection and analysis, as well as mixed-methods studies. 

Prior to joining PolicyLab, Ms. Bowden worked as the community health and wellness coordinator at a multi-service agency in Philadelphia where she was charged with developing and implementing programming for various populations throughout the city. Ms. Bowden received her Master of Social Work and Master of Public Health degrees from the University of Pennsylvania. During her graduate studies, she conducted original research examining men’s beliefs, intentions, and actions surrounding contraception and conception, and she served as a graduate research assistant at the Center for Injury Research and Prevention at CHOP on a study aimed at preventing risky teen driving.

Related Projects

Related publications and tools.

• Next page Next ›

Related News

Find out what’s new at PolicyLab   Learn More

Adolescent Health & Well-Being

Behavioral health, population health sciences, health equity, family & community health.

TEAM MEMBERS

The interdisciplinary team members at Clinical Futures work across a broad spectrum of specialties to research and share knowledge about best practices in pediatric care. The Clinical Futures team consists of core faculty members who are general pediatricians and pediatric subspecialists, along with a staff of research assistants, research associates, data analysts, and research administrators. CHOP researchers who wish to become members can contact Clinical Futures to learn more about the benefits and expectations. To view open positions at Clinical Futures, visit Careers.

• Research Staff

Kellyann Baxendell, MPH

Clinical Research Coordinator

Jesse Blumenstock

Craig Boge, MPH

Clinical Research Associate

Mickael Boustany, MD

Research Technician

Cadence Bowden, MSW, MPH

Clinical Research Project Manager

Timothy Brandon, MPH

Reiley Broms

Clinical Research Assistant

Rachel Brown MPH

Nellie Butler

Amanda Bwint

Arzu Cetin, MS

Jennifer Chapman, MPH

Project Manager

Karen Crew, BS

Clinical Research Program Manager

Mikia Croom, MS.Ed.

Miren Dhudasia, MPH

Gabrielle DiFiore, MPH

Douglas L. Hill, PhD

Behavioral Researcher

Mary Kate Kelly, MPH

Data Manager

Kayla Knowles

Giyoung Lee, MPH

Susan Lee, MPH

Research Program Manager

Adya Maddox, MPH

Judy Malone

Ashley Martin, MPH

Program Manager

Madeline McGuire

Didien Meyahnwi

Research Data Analyst

Megan Minucci

Kate Morrow, MSS, LSW

Bianca Okhaifor

Eva Partridge

Clinical Research Assistant 1

Molly Passarella

Statistical Programmer

Maura Powell, MPH

Manager, Possibilities Project

Naomi Pressman

Janani Ramachandran, M.S., M.P.H.

Danielle Sands, MPH

Minha Sarwar

Anna Sharova, MPH

Sydney Shuster, MPH

Brian Vazquez

Research Statistician

Lindsay Waqar, MPH, CCRC

Kadedra Wilson

Jordan Wood, MPH

Research Project Manager

Diana Worsley, MPH

Qualitative Methods Program Manager

Morgan Zalot Hammershaimb, MPH

Alvaro Zevallos Barboza, MPH

About Clinical Futures

• Core Faculty and Fellows
• Administrative staff
• Research Sponsors
• Data Resources
• In the News
• Press Releases
• About CHOP Enterprise

Clinical Impact

• Promoting Antibiotic Stewardship in Pediatric Outpatient Settings
• Pilot Grant Program
• Healthcare Delivery Science Research Grants
• The Possibilities Project
• IDEAS Research Group
• In-person Course Provides Training on Multilingual Approaches to Research
• Biostatistics
• Clinical Epidemiology
• Clinical Trials
• Comparative Effectiveness
• Implementation Science
• Social Science Methods in Healthcare Delivery
• Pediatric Hospital Epidemiology and Outcomes Research Training
• Academic General Pediatrics Fellowship Program
• Multilingual Child Health Research
• Training Program Alumni

Filter by Role

• Administrative Staff (11)
• Core Faculty and Fellows (87)
• Ideas Research Faculty (5)
• Ideas Research Staff (16)
• Research Staff (47)
• Senior Leadership (10)

Contact Information

We're sorry… the job you are trying to apply for has been filled.

Maybe you would like to consider the Categories below :

Project Management

At the end of this session, learners will be able to understand fundamental definitions and principles of project management, the relationship between scope, timeline, and resources, tools used in planning and managing projects, and unique challenges of health IT projects.

•   Bimal Desai, MD, MBI, FAAP

This seminar focuses on medical informatics and was delivered at the Open Medical Institute in Salzburg, Austria, from October 27 – November 2, 2019.

Content Disclaimer

The Terms of Use and Privacy Policy set forth on the website of The Children’s Hospital of Philadelphia apply to any and all uses of and access to this site and the content found here.

The work presented in the presentations, videos, and other content on this site (“Presentations”) includes publicly available medical evidence, a consensus of medical practitioners, and/or opinions of individual practitioners that may differ from consensus opinions. These Presentations are intended only to provide general information and need to be adapted for each specific patient based on the practitioner’s professional judgment, consideration of any unique circumstances, the needs of each patient and their family, the availability of various resources at the health care institution where the patient is located, and other factors. The Presentations are not intended to constitute medical advice or treatment, nor should they be relied upon as such. The Presentations are not intended to create a doctor-patient relationship between/among The Children’s Hospital of Philadelphia, its physicians and the individual patients in question. The information contained in these Presentations are general in nature, and do not and are not intended to refer to specific patients.

CHOP, The Children’s Hospital of Philadelphia Foundation and its or their affiliates, the authors, presenters, practitioners, editors, and others associated with the creation of the Presentations (“CHOP”) are not responsible for errors or omissions in the Presentations; for any outcomes a patient might experience where a clinician reviewed one or more such Presentations in connection with providing care for that patient; and/or for any and all third party content on the site or in the Presentations. CHOP makes no warranty, expressed or implied, with respect to the currency, completeness, applicability or accuracy of the Presentations. Application of the information in or to a particular situation remains the professional responsibility of the practitioner who is directly treating the patient.

To the extent that the Presentations include information regarding drug dosing, in view of ongoing research, changes in government regulations and the constant flow of information relating to drug therapy and drug reactions, the viewer should not rely on the Presentation content, but rather is urged to check the package insert for each drug for indications, dosage, warnings and precautions.

Some drugs and medical devices presented in the Presentations have United States Food and Drug Administration (FDA) clearance for limited use in restricted research settings. It is the responsibility of the practitioner to ascertain the FDA status of each drug or device planned for use in their clinical practice.

You shall indemnify, defend and hold harmless CHOP, The Children’s Hospital of Philadelphia Foundation, and its/their current and former employees, officers, and agents, trustees, and their respective successors, heirs and assigns (“Indemnitees”) against any claims, liability, damage, loss or expenses (including attorneys’ fees and expenses of litigation) in connection with any claims, suits, actions, demands or judgments arising directly or indirectly out of your reference to or use of the Presentations.

The Presentations are protected by copyright laws and in some cases patent laws, and all rights are reserved under such laws. No part of the Presentations may be reproduced in any form by any means, or utilized in any other way, absent prior written permission from the copyright owner.

By starting this module, you agree to our Content Disclaimer and Terms of Service.

Course Content

Course Includes

• Course Certificate

CHOP Employee? Log In Here

Username or Email Address

Forgot Password?

Remember Me

Clinical Research Project Manager / Lead / Senior

How to apply.

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

The University of Michigan Congenital Heart Center is seeking a Clinical Research Project Manager to serve as project manager and study coordinator for a pediatric, multi-center, investigator-initiated, FDA-regulated device clinical trial led by the University of Michigan.  The device is patient-specific and the IDE is held by a University of Michigan investigator.

This position may provide study coordination and/or project management for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from Clinical Research Coordinator - Senior and/or CRC Lead is required. This position has achieved mastery in all aspects of clinical research management. This position has oversight for clinical research projects and has responsibility for ensuring that they are completed within specifications. This position establishes operational objectives and assignments and defines and manages project resource needs including project staff. Employees in this classification typically analyze, compare, and evaluate various courses of action and have the authority to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities. Primary activities and decision-making authority are predominantly performed independently affecting business operations to a substantial degree.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Responsibilities*

The selected candidate will have both Project Management and Study Coordinator duties. These specific duties include:

Project Management. 

The selected candidate will:

• Serve as primary contact for sites participating in the multi-center clinical trial. Along with the UM team, the selected candidate will guide each site through study start up, enrollment, follow-up, and close out, and answer any questions that arise. 
• Write clinical trial documentation as needed.
• Work with the device manufacturer to ensure the patient-specific devices are manufactured, sterilized, and delivered on time to both UM and participating sites.
• Coordinator monitoring visits for participating sites.
• Work with the SABER team at UM to ensure the trial database is designed and operates per specifications. 
• Work with MICHR IND/IDE Investigator Assistance Program (MIAP) to ensure compliance with all applicable FDA regulations and reporting 
• Work with liaison to create and update clinicaltrials.gov registration.
• Along with finance team, monitor the clinical trial budget.
• Maintain regulatory binder.
• Maintain IRB application.
• Support Expanded Access use of the device under the IDE for children who are ineligible for the trial

Study Coordination. 

As UM is a participating site in the clinical trial, the selected candidate will:

• Ensure that subjects are consented, the protocol adhered to, and all regulatory documents are in order.
• Participate in all monitoring visits.
• Ensure data are entered, and queries answered, in a timely manner. 
• Work within CTSU framework for initiating and carrying out the clinical triall, including enrolling and tracking patients in OnCore.
• Process patient incentive reimbursements.

The selected candidate will be embedded in the congenital heart center research team (M-CHORD), which consists of a dedicated team of study coordinators, project managers, and an analytic team, and faculty leaders. The selected candidate may work from home on days where in-person work is not required, as agreed upon with the selected candidate's manager and the PI of the trial. After the initial start-up phase of the clinical trial, additional clinical trials and studies may become the responsibility of the selected candidate.  General responsibilities for this clinical trial, and future clinical trials and studies, are listed below. 

Clinical Coordinator Responsibilities  

• Demonstrates the ability to create and manage the logistics for a new clinical trial.
• Applies critical thinking and creative problem-solving skills in the development of new processes, procedures, tools, and training to enhance clinical research activities.
• Demonstrates the ability to evaluate a monitoring plan against protocol and relates the plan to study team members.
• Manage workloads and resources/procurement.
• Using available resources at the University, determines study site feasibility.
• Provides input on feasibility of new studies (workflow, resources, populations). Advises PI or clinical research teams of inconsistencies, errors or any issues of concern that may result in non-compliance or logistic issues.
• Assesses study budget for staff resource assessment.
• Proficient in study implementation.
• Knowledge of risk management strategies and principles.
• Responsible for workflow process and study planning.
• Develops tools and trainings to aid in the creation of study budgets and tracking of invoiceable items.
• May manage the research conduct at other sites if U of M is acting as a coordinating center for a multi-site study.
• Provide appropriate financial oversight
• Proficiency in budget and resource management
• Develops processes, tools, and training to enhance site compliance with the requirements necessary for the safe and effective development of investigational products.
• Demonstrated expert knowledge of clinical research systems.
• Assist in writing and review of protocols.

Data Coordinator Responsibilities   

• Develops or contributes to the development of processes, tools, and trainings to ensure the accurate collection of data at the site level.
• Performs at the highest level of data management, including the monitoring of data collection and reporting to ensure compliance.
• Oversees study conduct by staff and ensures quality work is done.
• Reviews manuscripts/poster presentations/abstracts as appropriate.
• Proficient in data management and results reporting.
• Demonstrates ability to create and manage the logistics for a new clinical research trial.
• Responsible for implementing study assessment needs. 
• Knowledge of the roles and responsibility of the various stakeholders in clinical research.
• Creates protocols for specimen collection, processing, shipping, etc., and implements procedures to maintain accuracy and efficiency.

Regulatory Coordinator Responsibilities  

• Performs internal audits and adjusts SOPs for the management of IPs according to FDA regulations and GCPs.
• Knowledge of fraud and misconduct identification, reporting, and management.
• Responsible for workflow process and study planning. 
• Facilitates internal and external audits. 
• Ensure study compliance Provides oversight and follows FDA- Good Clinical Practices (GCP) or OHRP guidance for clinical research. 
• Ensures ethical guidelines are reflected in SOPs by adapting any established procedures, processes, or workflows to reflect any new or updated regulations.
• Designs processes, tools, and trainings to guide study team members in the understanding, recognition, and documentation of subject protection and safety issues. 
• Proficient in regulatory and compliance matters.

Administrative Responsibilities  

• May run/delegate staff meetings 
• May provide administrative supervision of a team > 2 employees 
• May manage HR activities 
• Knowledge of management concepts of and effective training methods to manage risk and improve quality in conduct of a clinical research study. 
• Recruit and train appropriate personnel for clinical research
• Utilize staff performance metrics
• Knowledge of the principles and practices of leadership, management, and mentorship, and how to apply them within the working environment

Training  

• All training requirements of the previous level.
• Specialty training or expertise is achieved at this level.
• Completes Michigan Medicine training for Managing Successfully and Leading Successfully.
• Attends and participates in all training assigned to this level.

Required Qualifications*

Clinical Resource Project Manager:

• CRC Governance Committee review and approval 
• Master's Degree in Health Science or an equivalent combination of related education and experience is necessary.
• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent.  Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire.  (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
• Minimum 6 years of directly related experience in clinical research and clinical trials is necessary.  (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)   
• Excellent interpersonal, oral, and written communication skills Demonstrated knowledge of medical and research terminology.  Ability to work with minimal supervision with diverse teams of people in a diplomatic, collaborative, and effective manner
• Exceptional organizational and computer skills are required with proficiency in Microsoft software applications
• Demonstrated problem solving and conflict resolution skills.  Ability to multi-task, work well under time constraints and meet deadlines.

Clinical Research Coordinator Senior and Lead Required Qualifications:

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
• Minimum 5 years of directly related experience in clinical research and clinical trials is necessary.  

Desired Qualifications*

• Previous experience with coordination and management of device trials (IDE)
• Experience leading a multi-site clinical trial
• Demonstrated understanding of FDA regulations 
• Extensive experience with successful submissions to IRB
• Familiarity with congenital heart disease

Work Schedule

In this position you'll typically work Monday through Friday. Occasional weekend work may be required.

Work Locations

The in-person portion of this role will be at Mott Children's Hospital. The selected candidate may work from home on days where in-person work is not required, as agreed upon with the selected candidate's manager and the PI of the trial.

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

Skip to content

Marissa M. Di Miero, MBA

Education and Training

Undergraduate degree.

BS - Small Animal Science

Graduate Degree

MBA - (specialization in Entrepreneurship)

Titles and Academic Titles

Clinical Research Project Manager II

Departments and Services

• Hemostasis and Thrombosis Center

Patient Experience Ratings

About the patient experience rating system.

The Patient Experience Rating is an average of all responses to the care provider related questions shown above from our nationally-recognized Press Ganey Patient Satisfaction Survey. Patients that are treated in outpatient or hospital environments may receive different surveys, and the volume of responses will vary by question.

Responses are measured on a scale of 1 to 5 with 5 being the best score.

We are committed to true transparency. However, to ensure the comments are fair and correctly attributed, we review each one before posting to the website. We exclude entire comments that disclose patient's protected health information, are off-topic, or include other confidential or inappropriate content. Comments will appear on provider bios only if providers have a minimum number of comments.

Comments are shared internally for education purposes to ensure that we are doing our very best for the patients and families for whom we are privileged to care.

The comments are submitted by patients and families and reflect their views and opinions. The comments are not endorsed by and do not reflect the views of Children’s Hospital of Philadelphia.