Derek E. Coulter
Greater Portland
Summary
With a solid foundation in clinical operations and regulatory affairs, I am eager to learn and grow within this field. Possessing a strong analytical mindset and a collaborative approach, I have the essential skills for navigating complex clinical environments. My goal is to utilize and develop my project management and regulatory compliance skills in a Clinical Affairs role. I have a proven track record of directing clinical operations and managing clinical trials from inception to completion, utilizing strategic planning and regulatory knowledge to ensure compliance and operational excellence. I have also fostered team collaboration and achieved impactful results in clinical program management. As a problem-solving Clinical Affairs Director, I am qualified to manage health regulations, perform patient care, and motivate talented staff. With a background in achieving positive patient outcomes, finding creative solutions to administrative issues, and effectively interacting with diverse personalities, I am an enthusiastic professional ready to make a difference.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Director of Clinical Affairs
Canary Medical
Carlsbad, CA, USA
02.2023 - 09.2024
- Lead and manage Clinical Affairs
- Develops and manages the budgeting, designing, planning, resource management, institutional review board, legal agreement with sites, purchasing, execution and management of clinical trials
- Identifies, evaluates, and develops as needed all in-house personnel, consultants and contract clinical management firms needed to support the Canary’s clinical program
- Selects, develops, and evaluates needed resources to ensure the efficient operation of the clinical affairs function
- Ensures clinical trials are well managed by identifying and successfully managing relationships with vendors
- Develops successful clinical protocols for pre-market and post-market studies to drive positive outcomes for clinical trials
- Provides clinical program management for study activities
- Co-authors clinical sections of regulatory submissions
- Conducts site selection, qualification, feasibility assessments with clinical trial sites
- Conducts or participates in research activities for new methods of measurement and analysis in pursuit of Canary’s marketing and clinical goals
- Works closely with Clinical Science units to ensure a coordinated approach to statistical and data management activities
- Collaborates cross-functionally with departments such as Marketing, Regulatory Affairs, R&D and Quality to ensure clinical program compliance and to determine development timelines, resources requirements, program costs etc
- Provides early strategic input into protocol design
- Achieves enrollment rates consistent with company goals
- Ensures compliance with/and training for good clinical practices, good documentation practices, and regulatory guidelines, ensuring adherence to domestic and global regulations
- Engage Key Opinion leaders, Professional Societies, Payers, and Providers to understand trends in care and uncover critical insights to support product innovation
- Provide oversight for the development of materials to be used for study execution (investigator brochures, training materials, etc.)
- Ensure adverse events from clinical research studies are reviewed, trended and escalated as needed
- Work with Regulatory and Medical affairs partners to prepare reports on clinical investigations in preparation for submission to regulatory agencies and/or for publication, to meet evidence requirements
- Account for the clinical content of internal product documentation and regulatory submissions for new products and for renewals
- Approve Design History Files, Technical Guides and Clinical Evaluation Reports (CERs) as part of the creation of product-specific design dossiers/technical files
Clinical Affairs Program Manager - Motion Preservation
Spinal Kinetics a subsidiary of Orthofix Medical Inc.
Lewisville, TX, USA
07.2020 - 02.2023
- Responsible for comprehensive global clinical study(ies) management, consisting of, not limited to:
- Conducting clinical research programs in accordance with approved project plan, compliance to company standard operating procedures and applicable regulations
- Clinical project planning and management in keeping with the global corporate directive and strategic goals
- Overall project budget and timeline development and execute accordingly
- Accountable for achieving enrollment targets and patient follow-up commitments
- Able to adapt and execute should strategic goals shift during the life of the project
- Detecting project risks and capable of addressing with mitigation plans and alternative solutions
- Provide Quality Assurance support and management level representation during audits and inspections
- Analyze and develop action plans for investigational sites, vendor and administrative issues
- Develop project-tracking systems and provide accurate progress reports on assigned studies and sites
- Continually assess study site issues, implement corrective action, and document results
- Oversee and contribute to development of key study documents including, but not limited to study protocols and protocol synopses, protocol amendments, study plans and procedure manuals, project tools, informed consent forms and clinical study reports
- Accountable for CRF and database development process, accurate and timely quality data collection and monitoring
- Lead and mentor CRAs in activities and functions as necessary to support assigned projects
- Ensure PI and site personnel engagement are adequately maintained
- Screen and recruit clinical research investigators (and laboratories, as applicable)
- Screen, recruit, qualify, train, and monitor investigators and their staff for study participation and protocol compliance
- Develop appropriate budgets, negotiate contracts and prepare agreements for the conduct of clinical trials at investigative centers
- Interact with site and central IRBs and ECs to ensure study document approval in a timely manner, leading to site activation
- Plan, prepare and present at Investigator and Research Coordinator Meetings
- Organize and assist with the implementation of investigator meetings (as applicable)
- Work with investigative sites to ensure subject safety in all areas of clinical research, following procedures to report SAEs and UADEs to clinical and regulatory management
- Prepare data outputs for written and verbal presentations of study data for symposia, scientific presentations and exhibits, and FDA submissions, as appropriate
- Manage the handling of clinical study-related questions from doctors, patients, and sales force, as appropriate
- Promote good communication within the clinical department, as well as with other Orthofix department members
- Collaborate with R&D, marketing, and other departments to ensure alignment with project goals, as appropriate
- Contribute to the compilation of FDA submissions as well as the compilation of documents needed for CE-marking
- Including working as a Quality Engineer clearing product complaints and drafting FDA annual and Close-Out reporting requirements
North American Clinical Studies Manager
Limacorporate S.p.A.
San Daniele del Friuli, Udine, Italy
10.2017 - 03.2020
- Responsible and accountable for the execution, management, and monitoring of all clinical study activities for the United States
- Provide leadership and expertise to ensure successful completion of all study-related activities
- Responsible for all clinical trial activities including protocol and case report form development, investigator selection, preparation of trial related documentation and IRB submissions with follow-through to ensure a successful outcome
- Responsible for contract negotiation, overall study budget and site budgets; manage study progress to ensure study is on time and within budget
- Manage and monitor all study sites from site start-up to study close-out – set up the trial sites, train the study staff to trialspecific activities, and close down trial sites on completion
- Organize and participate in kick-off and investigator meetings to review progress of ongoing clinical trials
- Develop and maintain good working relationships with investigators and study staff; liaise and communicate with internal business partners
- Build a strong relationship with KOLs and Investigators and provides support for Presentations and publications in cooperation with the Marketing and Scientific team; Track and report on progress of study including site activation, patient enrolment, monitoring visits;
- Verify data entered for consistency with original data source, track completed CRFs and timely respond to queries and requests;
- Monitor the trial throughout its duration, which involves both remote monitoring and visiting the trial sites on a regular basis;
- Liaise and communicate with study staff on conducting the trial;
- Maintain and update project files and documentation;
- Analyze data, discuss results and prepare reports/clinical presentations
- Organize and participate in kick-off and investigator meetings to review progress of ongoing clinical trials;
- Review AEs and ensure adequate communication to NCA according to procedures
- Coordinate the activities with Contract Research Organizations, if involved
Clinical Project Manager
BIOTRONIK, INC.
Lake Oswego, Oregon, USA
01.2017 - 08.2017
- Manage the entire lifecycle of clinical trials
- Define and author clinical investigation documents as required by ISO14155, ICH-GCP, and applicable standards
- Plan and control the budget, supervise the monitoring for assigned clinical studies
- Report relevant details and milestones to the management
- Maintain regular visits with study investigators and other study specific interfaces
Clinical Operations Manager
Zimmer Biomet (Formerly LDR Spine)
Austin, Texas, USA
10.2013 - 01.2017
- Manage all study projects from development to closure
- Manage CRA activities
- Protocol adherence and training for all CRAs and study sites
- Ensure CRAs are properly trained for clinical research and study activities
- Mentor and work with CRAs to resolve issues identified at study sites
- SOP adherence and training for all CRAs
- Manage Data Manager activities
- Ensure EDC is built and maintained according to study needs
- Review and compile Data Management Plans
- Vet and review all study vender needs and status
- SOP review and development for all new and existing SOPs
- Protocol development, review, adherence and training
- Identify and Vet all potential surgeons/sites for all new and existing studies
- Obtain and maintain all IRB applications and approvals per applicable regulations
- Maintain and ensure quality of data in the active study databases
- Adhere to all applicable regulations and GCP/ICH guidelines
- Monitor or co-monitor when necessary for training, quality and project compliance purposes
- Document all activities for all above referenced activities as part of the quality system and best practices
Clinical Research Associate II
PPD
Austin, Texas, USA
05.2013 - 10.2013
- Monitor for various Phase I studies at various sites in the U.S
- Serve as a contact with individual investigative sites
- Attend sponsor calls and internal team calls to stay informed of current study issues
- Provide direct support to the Clinical Team Manager by assisting with monitoring visit report review
- Serve as a mentor/trainer for junior CRAs with general and study-specific monitoring issues
- Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices
- Conduct site visits to determine protocol and regulatory compliance and prepared required documentation
- Develop collaborative relationships with investigative sites, client company personnel and study vendors
- Review Protocol, Investigator’s Brochure and project-related literature to develop an understanding of the study and therapeutic area
- Manage the essential documents as required by local regulations and ICH/GCP guidelines, before, during, and after a clinical trial
- Conduct all types of monitoring site visits, including site evaluation, initiation, interim, and close-out monitoring visits, in accordance with ICH/GCPs, SOPs and FDA guidelines
- Perform100% source document review to ensure adherence to protocol requirements and federal regulations and ensure case report forms are consistent with source documentation
- Perform drug accountability: assess investigational product through physical inventory and records review
- Assist study site with timely resolution of queries to ensure database timelines are met
- Ensure SAEs are promptly reported to safety monitoring groups and followed until resolution and all other AEs are appropriately documented at the site and assessed by the Principal Investigator
- Composes monitoring guidelines that outline how the study will monitored from start to finish
- Create a site initiation presentation and trains the site on the protocol and ICH/GCP guidelines
- Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner
- Develop collaborative relationships with investigative sites and client company personnel
CRA I
DJO Surgical
Austin, Texas, USA
09.2010 - 12.2012
- Monitor for various Phase I studies at various sites in the U.S
- Serve as a contact with individual investigative sites
- Attend sponsor calls and internal team calls to stay informed of current study issues
- Provide direct support to the Clinical Team Manager by assisting with monitoring visit report review
- Serve as a mentor/trainer for junior CRAs with general and study-specific monitoring issues
- Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices
- Conduct site visits to determine protocol and regulatory compliance and prepared required documentation
- Develop collaborative relationships with investigative sites, client company personnel and study vendors
- Review Protocol, Investigator’s Brochure and project-related literature to develop an understanding of the study and therapeutic area
- Manage the essential documents as required by local regulations and ICH/GCP guidelines, before, during, and after a clinical trial
- Conduct all types of monitoring site visits, including site evaluation, initiation, interim, and close-out monitoring visits, in accordance with ICH/GCPs, SOPs and FDA guidelines
- Perform100% source document review to ensure adherence to protocol requirements and federal regulations and ensure case report forms are consistent with source documentation
- Perform drug accountability: assess investigational product through physical inventory and records review
- Assist study site with timely resolution of queries to ensure database timelines are met
- Ensure SAEs are promptly reported to safety monitoring groups and followed until resolution and all other AEs are appropriately documented at the site and assessed by the Principal Investigator
- Composes monitoring guidelines that outline how the study will monitored from start to finish
- Create a site initiation presentation and trains the site on the protocol and ICH/GCP guidelines
- Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner
- Develop collaborative relationships with investigative sites and client company personnel
Quality Assurance Coordinator/Lab Supervisor
03.2009 - 09.2010
- Responsibilities include calibrating equipment, maintaining analyzers, writing reports for submission to the EPA and performing various analyses on samples
- Track calibrations over long periods to ensure proper calibrations
- Developing analyzer cabinets and analyzer design for use at various sites around the world
- Maintaining various inventories in both wet and analyzer laboratories
Environmental Technical
Myramid Analytical
Austin, Texas, USA
04.2008 - 03.2009
- Responsibilities include calibrating equipment and maintaining analyzers in the field and in the lab
- Conduct air and water quality sampling and collection
- Writing reports for submission to the EPA and TCEQ
- Performing various analyses on samples
Education
B.S. - Biology
West Texas A & M University
Canyon, Texas12-2008
Skills
- MS Office (including Teams and Skype for Business), CTMS, EDC (OC-RDC) PATS, Datatrak, Oracle, Merge eCOS, LimeS, rED Cap, basic PYTHON skills, Florence eTMF
- Clinical trial management, clinical research (protocol development, GCP adherence, regulatory compliance, ethics committee compliance, audit readiness, records management)
- Strategic planning
- Budget development and management, resource allocation planning
- Vendor management experience
- Therapeutic area expertise
- Project management experience
- Team leadership capabilities, staff development, and collaboration
- Continuous process improvement
- Site selection, development and management
- Investigator relationship building, stakeholder engagement
- Reliability
Accomplishments
Worked collaboratively to manage clinical studies from inception to completion utilizing interpersonal skills to meet goals and develop a systematic to meet goals from publications to device approvals.
Certification
Certified Clinical Research Professional, SoCRA, September2012
Affiliations
- Member of the Society of Clinical Research Associates since2010
- Member of the Association of Clinical Research Professionals since2014
Training
- Society of Clinical Research Associates (SOCRA)27th Annual Conference, September2018
- Society of Clinical Research Associates (SOCRA)24th Annual Conference, September2015
- Q1 Productions8th Annual Medical Device Clinical Trials Meeting Chicago, IL December2014
- ACRP2014 Global Conference, San Antonio, TX, April2014
- PPD Foundations Training, May2013
- 2st Annual Conference, SoCRA, Las Vegas, NV, September2012
- Clinical Research Professional Certification Preparation and Review Course, SoCRA, Las Vegas, NV, September2012
- Sixth Annual Device Clinical Research Conference, Q1 Productions, Baltimore, MD, March2012
- MAGI’s Clinical Research Conference, MAGI, Las Vegas, NV October2011
- Clinical Trial Requirements, Regulations, Compliance and GCP, Society of Clinical Research Associates (SoCRA), Denver CO, May2011
- Comprehensive Monitoring for Medical Devices, Barnett Educational Services, Chicago, IL October2010
Timeline
Director of Clinical Affairs
Canary Medical
02.2023 - 09.2024
Clinical Affairs Program Manager - Motion Preservation
Spinal Kinetics a subsidiary of Orthofix Medical Inc.
07.2020 - 02.2023
North American Clinical Studies Manager
Limacorporate S.p.A.
10.2017 - 03.2020
Clinical Project Manager
BIOTRONIK, INC.
01.2017 - 08.2017
Clinical Operations Manager
Zimmer Biomet (Formerly LDR Spine)
10.2013 - 01.2017
Clinical Research Associate II
PPD
05.2013 - 10.2013
CRA I
DJO Surgical
09.2010 - 12.2012
Quality Assurance Coordinator/Lab Supervisor
03.2009 - 09.2010
Environmental Technical
Myramid Analytical
04.2008 - 03.2009
B.S. - Biology
West Texas A & M University