Heather Cathrall, CIP, MBE

Experience

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  Social Networks

  Aug 2003 - May 2004

  Research Assistant

  Description: This study analyzed longitudinal data from a group of women who graduated Mills College in the 1950s. It compared social networks over the life span, with specific interest into how the central verses the peripheral social networks change with time. Responsibilities: Interviewing and giving questionnaires to subjects, analyzing data, collaborating on theories, data entry, extensive reading. Prepping and running subjects to see how social network changes affect people today. Working with limited verses expansive time perspectives and seeing how change in time perspective can change people's desire for information seeking verses emotion regulation behaviors. August 2002 to January 2004 "Motivational Research"Prof. Marty Covington 2001 Presidential Chair in Undergraduate EducationUC BerkeleyDescription: This study assessed the motivational climate in classrooms and how that climate changes as teaching changes. In addition, this study looked at self-worth theory in students to implement ways to motivate students to pursue learning for its own intrinsic satisfactions rather than out of grade-focused fear. This research studied intrinsic and extrinsic motivation in a school setting and implemented policy changes in the classroom environment.Responsibilities: Developing survey questions, data analysis, collaborating on publications, theory development, and presentations of work. Show less

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  Children's Hospital of Philadelphia

  May 2004 - Jan 2005

  Research Associate/Research Technician II

  Responsibilities: Collect chart and database information acquired from Children's Hospital neuroblastoma patients to be analyzed in an effort to see which treatments are most effective.; Medical Investigation of Neurodevelopmental Disorders (M.I.N.D.) Institute UC Davis Tony Simon, Ph.D.Responsibilities: Conduct neurological research with 22q11.2 deletion syndrome, Turners syndrome, Williams syndrome, Fragile X, cardiac patients, and control children. Work with research subjects and parents to complete data collection, behavioral tests, and MRIs. Analyze behavioral and neuroimaging data, assist in running fMRIs, and develop new tests and research ideas for additional projects. Accomplishments: I relocated to California when the Principal Investigator took the new position to help him set up the research lab, train new research assistants, update the equipment to work with the scanners and computer systems at UC Davis, and to begin contacting and enrolling subjects. I was involved in all aspects of closing protocols at CHOP and opening protocols through the UC Davis IRB. The study was successfully transferred and research has continued. I am co-author on a publication that resulted from one of the studies I worked on with this project (see below under Publications).(Note: Project relocation to MIND Institute) Show less

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  M.I.N.D. Institute, UC Davis California

  Jan 2005 - Jun 2005

  Research

  Research AssistantPI: Tony Simon, Ph.D.Continued on Research Project begun at CHOP when PI moved to UC Davis.Continuation of previous position. I assisted in setting up the research lab, working with subjects and training new technicians.Reason for leaving: Cross Country move back to the Children's Hospital of Philadelphia

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  Children's Hospital of Philadelphia

  Jun 2005 - now

  Lead the Investigational New Drug (IND) / Investigational Device Exemption (IDE) Office• Oversee operational functions for new drug / device programs including consultation and regulatory support• Lead the development of policies, procedures, guidance, templates, and tools • Conduct administrative oversight of the scientific review committee• Assist with FDA submission and study team supportLead the Recruitment Enhancement Core• Assist in leading a strategic review of the research recruiting services and implement process improvement and initiatives resulting from the strategic review• Oversee the provision of services for recruitment within clinical research projects• Collaborate to build processes that ensure patient and family voices within research• Collaborate to design marketing, advertising, and public relation plans • Develop professional relationships with peer groupsLead Research Family Partners - assists CHOP research teams by engaging family perspectives, advocates, and patients in research planning and discussions.Other Responsibilities• Support the management of clinical trial systems (OnCore, REDCap Support) • Participate in strategic planning for the evolution of programs • Identify and advocate for appropriate support, resources and HR needs of programs • Develop and report on various performance metrics such as usage, support needs, governance, and general health of programs• Creates and delivers educational opportunities and materials for programs• Ensures programs are effectively communicated and marketed to stakeholders through outreach, events, marketing strategies, and new initiatives• Hire, manage and develop staff to create and sustain high performance teams.• Ensure team compliance with department and hospital policies and procedures• Assist in managing annual budget and expenditures Show less Assistant Director since July 2011, worked in CHOP IRB office since June 2005Responsibilities: Maintain a current understanding and working knowledge of institutional policies, state laws, and federal regulations regarding human subject research, including 45 CFR 46, 21 CFR 50, 21 CFR 56, 45 CFR 164, 21 CFR 312, and 21 CFR 812.Serve as the project lead for Final Rule Implementation at CHOP. Ensure appropriate staffing for the IRB office and provide oversight and leadership to the IRB staff. Responsible for triaging and oversight of all IRB submissions including ensuring timely review of new protocols, modifications, continuing reviews, completions, serious adverse events, unanticipated problems, exemptions, etc.Provide training to the research community, including educational training as a result of compliance concerns. Monitor and interpret current and changing regulatory legislation and polices, and ensure new regulations or changes to existing regulations are communicated to the research community. Project lead for the IRB’s electronic submission system development, integration and maintenance. Provide support to faculty members with diverse portfolios of both domestic and international research projects. Advise investigators on drug, biologic, and device regulations, and provide guidance on the preparation of protocols and consents that involve INDs, IDEs (PMA & 510k), HUDs, etc.Function as a liaison between the IRB Committees, investigators, study staff and other departments involved with research within CHOP. Lead presentations both within the hospital and at national conferences.Develop and implement IRB SOPs.Assist with initial and continuing AAHRPP Accreditation (Fully Accredited since 2010) including site inspections.Assist with IRB Full Board oversight, member recruitment & training. Serve as an IRB Member and designee of the IRB Chair.All responsibilities as listed below under Analyst III position. Show less Responsibilities: Manage analysts and front end staff. Triage assignments and assure time processing goals are met. Manage metrics reports. Provide quality assurance reviews and feedback. Function as a liaison between the IRB Committees, investigators, and study staff. Facilitate cooperative efforts between the IRB and CTRC. Assist in communications with technology transfer, grants, and collaborative departments. Manage special projects. Meet regularly with analysts to educate and update them. Work on developing and improving forms, SOPs, and office procedures. Implemention of the electronic CLICK Commerce System including, but not limited to: Alpha/Beta testing the system and help in the development and training. Lead education sessions; develop training material; work on patch updates; development testing of new electronic processes; issue logging and meeting with developers on a regular basis to improve system functionality. Meet with investigators and study staff to help address research questions and provide education and outreach to the research community. Assist with AAHRPP Accreditation Process. Hire and train new IRB staff. Manage IRB Membership and recruit new members. Overall Office Review and Improvement Initiatives. Accomplishments: Development of workflows for the electronic IRB system; worked on improving efficiency in the office and worked with individual analysts to improve organizational skills and understanding of the regulations; helped develop training tools for new analysts and helped to train several new hires. In charge of staffing IRB committees, training members, corresponding to ancillary committees, leading staff meetings. Development of new and updated forms, SOPs, and letter templates. Serve as an IRB member and help facilitate adhoc meetings and review compliance issues. Serve as a resource for the IRB transitions and work on special projects as needed.Reason for leaving: Promoted Show less Responsibilities: Create agenda and minutes, assign reviewers, and ensure completeness of meeting packets for the IRB Full Board Committees. Pre-Review full board and expedited submissions. Help train new IRB members and new IRB staff. Conduct timely reviews with thorough processing for new protocol submissions, modifications, continuing reviews, completions, unanticipated problems, exemptions, and other research submissions. Correspond with investigators and study team members addressing their questions, providing insight and information on the regulations, and working with them to develop submissions that are approvable to help them achieve their study objectives. Assisting on special projects as needed. Continual training including PRIM&R, MSMRC, conferences, lectures, continuing education, IRB Forum, and visiting other IRBs such as Ohio Children's Hospital. Involvement in testing of the electronic submission system and pre-review of proposed smart forms. Generate stipulations, approval letters, response to internal audit findings, and documentation of full reviews. Review, triage, and follow-up of all SAEs, protocol deviations, violations, study complaints, Investigator's Brochure and Package Insert updates submitted to the IRB. Involvement in all aspects of processing and reviewing IRB submissions.Accomplishments: Implementation of an SAE review group to ensure efficient processing and appropriate expertise in the review of SAEs, protocol deviations, and other unanticipated problems relating to research. Development of forms, SOPs, and metrics tools. Assisted IT staff with understanding IRB processes so that the Stokes FileMaker Pro Database could be updated to capture needed information. Helped set up IRB membership when a third IRB Committee was added to ensure adequate expertise on all three Committees. Provided backup for other IRB staff who go on leave or are backlogged. Helped recruit and train new IRB staff.Reason for leaving: Promoted Show less

  • Director, Clinical Trial Support

    Jul 2024 - now

  • Administrative Director, Clinical Trial Support

    Aug 2021 - Jul 2024

  • Assistant Director, Clinical Trial Support

    Mar 2019 - Aug 2021

  • Assistant Director Compliance & Regulatory Affairs, IRB Operations

    Jun 2011 - Mar 2019

  • IRB Analyst III/Manager

    Jul 2008 - Jun 2011

  • IRB Analyst I /IRB Analyst II

    Jun 2006 - Jul 2008

  • IRB Resource Coordinator

    Jun 2005 - Jun 2006
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  University of Pennsylvania

  Jan 2009 - Sept 2012

  Guest Faculty/Facilitator

  Course: Ethics of Human Subjects Research

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  Pine Hill Schools

  Sept 2020 - now

  Pine Hill School Board Member (Elected Office/Volunteer Position)

  Pine Hill School Board Member