Carolyn Dougherty
Carbondale,CO
Summary
Effective professional leader with comprehensive experience at a full service CRO excelling in clinical project management and operations. Proven track record in enhancing operational efficiency and managing multi-site clinical trials. Adept at team management and quality assurance, driving successful outcomes in complex research environments.
Overview
14
14
years of professional experience
1
1
Certificate
Work History
Associate Director of Operations
Vexillum Biospecimen Solutions (CRO)
Carbondale, CO (Remote)
08.2023 - Current
- Develop and implement strategies to improve operational efficiency, productivity, and cost savings.
- Manage the daily clinical operations of a multi-site contract research organization.
- Provide guidance and support to the executive team on overall business strategy, policy development, and process improvement initiatives.
- Maintain the human biospecimen biobank inventory.
- Create detailed project plans outlining tasks and resources needed for the successful completion of projects within set timelines.
- Develop and refine short- and long-term strategies to drive growth and profitability.
- Manage relationships with partners and vendors to align with company goals.
- Organize and oversee capital improvement projects to maintain business viability.
- Contribute to the recruitment, training, and retention of top talent, enhancing organizational capability.
Sr. Clinical Research Associate
iProcess Global Research (CRO)
Carbondale, CO (Remote)
04.2022 - 08.2023
- Senior execution team lead on a cross-functional CRO team, providing guidance, mentorship, and support for maximum team productivity.
- Direct clinical trial project management for the collection of clinical research biospecimens.
- Primary point of contact for global sponsor relations and CRO communications.
- Principal leader in the identification, evaluation, and selection of clinical trial sites for each clinical trial protocol.
- Coordination of successful clinical trial project start-up including site selection, protocol drafting, informed consent drafting, IRB submission, site initiation, and site training.
- Continuous CRA oversight including IRB maintenance, trial oversight, data management, query resolution, CTMS and eTMF maintenance and completeness.
- Management, qualification, and selection of external clinical trial vendors and reference laboratories to maintain compliance.
- Precise tracking of investigational devices, collection kits, clinical trial supplies, and human biospecimens.
- Generation of project estimates and associated budgets for the execution of contracts with sponsors and sites.
- Conduct clinical trial source data verification via on-site and virtual site monitoring visits to document and send routine monitoring letters for clinical trial compliance.
- Create and maintain essential clinical trial documents to support audits and inspection activities.
- Leader of process improvement initiatives and departmental projects.
Director of Research
Mountain Neurological Research Center at Roaring Fork Neurology
Basalt, CO
09.2018 - 04.2022
- Clinical Research Department Director at a privately owned neurological practice for Phase I, II, III, and IV pharmaceutical clinical trials, including interventional, registries, and observational trials.
- Managed a team of research coordinators for the successful completion of clinical research visits involving neurological disorders.
- Administrator for study start-up, IRB and regulatory submissions, budget and contract negotiations, budget drafting, and accounting/reconciliation.
- Supervisor of monitoring visits, audits, data management, and study close-out to facilitate effective monitoring visits.
- Recruited, hired, and oriented departmental staff to create a positive and rewarding work environment.
- Monitored progress against established goals, timelines, and budgets for each project.
- Assisted in developing budget proposals for upcoming projects and allocated resources accordingly.
Clinical Research Coordinator
Colorado Center for Reproductive Medicine
Lone Tree, CO
11.2017 - 09.2018
- Coordinate and direct clinical interactions between the in-house research lab, clinic, and on-site surgical suite for clinical research purposes.
- Recruiting patients for physician-initiated clinical research protocols.
- Integral clinical research liaison for state-of-the-art patient care, with national and industry-leading success rates for the treatment of infertility.
- Efficient and accurate handling and processing of biological specimens for clinical trial outcomes assessments.
- Meticulous record-keeping of investigational drug storage, administration, and destruction.
- Punctual regulatory management, including IRB submissions and continuing review reports, to ensure seamless regulatory compliance.
- Lead data management and data analysis for use in peer-reviewed journal articles.
Director of Research
Denver Esophageal and Stomach Center
Denver, CO
10.2013 - 11.2017
- Clinical coordination of surgical treatments for disorders of the stomach and esophagus ensuring a smooth and effective clinic flow.
- Lead clinical research coordinator for investigational device clinical research studies, including Humanitarian Use Device trials.
- Clinical project management of physician-initiated clinical research studies, including publishing surgical outcomes, and database registries.
- Clinical trial management duties include study start-up, IRB and regulatory submissions, budget drafting, contract review and execution, statistical analysis, and journal drafting to ensure end-to-end clinical trial success.
- Drafting and submission of research grants to fund in-house clinical research trials.
- Orchestration of patient screening, consent, enrollment, and follow-up.
- Completion of drawing, collecting, and processing of biological specimens.
Clinical Research Coordinator
Siouxland Hematology and Oncology Associates
Sioux City, IA
05.2012 - 06.2013
- Provide patients access to immunosuppressive chemotherapy via privately funded and government-funded clinical research trials.
- Obtain essential skills such as professional patient interaction, data management, and communication in a large oncology practice.
- Complete long-term patient follow-up to complete clinical patient outcomes.
- Identify potentially eligible oncology patients through pre-screening and chart review.
- Inform the oncology physicians of new research opportunities for their patient populations.
Clinical Research Coordinator
Sanford Hospital
Sioux Falls, SD
01.2012 - 05.2012
- Collaboration with a team of medical and clinical professionals at a large multi-state hospital system, including oncologists, pharmacists, nurses, and radiologists.
- Presentation of clinical research protocols at grand rounds to evaluate oncologic patients for participation in clinical research trials.
- Providing oncological treatment to a rural, diverse population.
- Extensive review of patient medical records to pre-screen and identify potential patients for clinical trial enrollment.
- Adverse Event and Serious Adverse Event Follow-Up for patient safety and reporting.
- Resolution of queries to accomplish study close-out visits.
Research Assistant
University of Colorado Health Sciences Center
Denver, CO
11.2010 - 01.2011
- Maintenance of cell lines in primary tissue culture, and treatment of cell lines with hormone therapy, anti-proliferative chemotherapeutic drugs, and metabolic inhibitors for publishing.
- Fixing and staining of cell lines for viewing and analysis to study cell viability using the ViCell counter.
- Preparation of cells for analysis using NMR.
- Use of the Western Blot biochemistry technique.
- Extraction of RNA from cell lysates to study gene expression.
- Small animal handling certification for the generation of xenografts in mice to complete mice micro-PET scans.
- Measurement of triglyceride content in cell lines using the TG assay.
- Infection of cells with shRNA to silence specific genes.
- Analysis of project data to complete publication for a peer-reviewed journal article.
Education
Bachelor of Arts - Biology
University of Denver
Denver01.2011
Bachelor of Arts - Spanish
University of Denver
Denver, CO01.2011
Skills
- Clinical trial management
- Stakeholder engagement
- Strategic planning
- Budget management
- Effective communication
- Employee training
- Vendor management
Certification
- Certified Clinical Research Coordinator, 2019 – Present
- Good Clinical Practice, 2012 – Present
- OSHA Bloodborne Pathogen Training, 2012 – Present
- IATA Certification, 2015 – Present
- BLS Certification, 2019 – Present
- Phlebotomy Certification, 2019 – Present
- SAE Reporting, 2019 – Present
Timeline
Associate Director of Operations
Vexillum Biospecimen Solutions (CRO)
08.2023 - Current
Sr. Clinical Research Associate
iProcess Global Research (CRO)
04.2022 - 08.2023
Director of Research
Mountain Neurological Research Center at Roaring Fork Neurology
09.2018 - 04.2022
Clinical Research Coordinator
Colorado Center for Reproductive Medicine
11.2017 - 09.2018
Director of Research
Denver Esophageal and Stomach Center
10.2013 - 11.2017
Clinical Research Coordinator
Siouxland Hematology and Oncology Associates
05.2012 - 06.2013
Clinical Research Coordinator
Sanford Hospital
01.2012 - 05.2012
Research Assistant
University of Colorado Health Sciences Center
11.2010 - 01.2011
Bachelor of Arts - Biology
University of Denver
Bachelor of Arts - Spanish
University of Denver
References
References available upon request.
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