Maureen Marcinik
Lothian,MD
Summary
Highly qualified and experienced medical research professional skilled in all aspects of clinical trial coordination, protocols, and participant relationships. Experienced in both medical practice and clinical research environments. Demonstrate strong working knowledge of ICH-GCP, company standard operating procedures, ALCOA, regulatory guidelines, protocols and monitoring guidelines. Communicate effectively with medical personnel, colleagues, and study participants. Consistently perform at peak professionalism, adhering to code of ethics and business standards. Experienced in multiple study areas, including COVID-19, dermatology, diabetes, hypertension, gastroenterology, gynecology, autoimmune disorders, cardiovascular, women's health and psychiatry. Recognized for initiative, organization, time and task management, sound problem solving skills and flexibility.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Remote Clinical Research Coordinator II
Science 37
Culver City, CA
12.2020 - Current
- Currently Coordinating Study with almost 200 participants and completing study start up for two other studies.
- Monitor clinical trial activities to support timely and accurate completion of studies.
- Comply with research protocols by providing ongoing quality control audits.
- Manage patient recruitment, informed consent process and data entry to support trial objectives.
- Reviewed referral information and kept track of intakes from various referral sources.
- Screen patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Follow informed consent processes and maintained records.
- Work with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collect data and followed research protocols, operations manuals, and case report form requirements.
- Participate in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Maintain compliance with protocols covering patient care and clinical trial operations.
- Maintain accurate and up-to-date case report forms and source documents for traceability.
- Follow clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Monitor patient safety throughout clinical trials and reported any adverse events.
- Develop and maintained accurate and up-to-date case report forms and source documents.
- Collaborate with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Possess willingness to work in a diverse environment and value the importance of teamwork.
Certified Clinical Research Coordinator
Investigative Clinical Research
Annapolis, MD
05.2018 - 09.2020
- High Enroller for Two large Gastroenterology Studies.
- Ensured study documents are tracked, file, maintained, and archived in audit-ready condition
- Aided facilitation of study monitoring visits
- Built relationships with investigators and site staff
- Participated in Investigator and other external or internal meetings as required
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Gathered, processed, and shipped lab specimens.
- Followed informed consent processes and maintained records.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Reviewed referral information and kept track of intakes from various referral sources.
- Complied with research protocols by providing ongoing quality control audits.
- Collected, evaluated, and modeled collected data.
- Prepare visits for next day, ensuring accuracy of source documents and assessments
- Filing of lab results, EKG results, and other communication in designated charts
- Timely completion of data entry for all e-Case Report Forms as well as paper CRF completion and transmission.
- Documented and conducted appropriate correspondence regarding adverse events, including severe adverse events
Clinical Research Coordinator
Anne Arundel Medical Center (Now Luminus Health)
Annapolis, MD
05.2016 - 04.2018
- Maintained working knowledge of and ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures.
- High Enroller for Pulmonary Embolism D-Dimer Study and others.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Gathered, processed, and shipped lab specimens.
- Followed informed consent processes and maintained records.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Monitored unit budget to meet financial objectives for spend rate and funding.
- Reviewed referral information and kept track of intakes from various referral sources.
- Complied with research protocols by providing ongoing quality control audits.
- Expertly conducted full range of patient and protocol assessments, including safety and efficacy, vital signs and EKGs.
- Maintenance of study regulator documents, including screening and enrollment logs, drug accountability logs, subject identification logs, site signature logs
- Coordinate and oversee clinical assessments of clients participating in clinical trial studies of vascular, hypertension and diabetes.
Clinical Research Coordinator
The Center For Sexual Wellness
Annapolis, MD
06.2013 - 05.2016
- The ONLY clinical research coordinator at this site.
- Reviewed referral information and kept track of intakes from various referral sources.
- Monitored unit budget to meet financial objectives for spend rate and funding.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Complied with research protocols by providing ongoing quality control audits.
- Gathered, processed, and shipped lab specimens.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Conducted gynecological studies with Dr. Andrew Goldstein.
Clinical Research Coordinator
Burke Internal Medicine
Burke, VA
01.2011 - 06.2013
- Followed informed consent processes and maintained records.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Gathered, processed, and shipped lab specimens.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Complied with research protocols by providing ongoing quality control audits.
- Conducted osteoarthritis,gout, diabetes and hypertension studies.
Clinical Research Coordinator (temporary)
Metropolitan Liver Disease/Gastroenterology Center
Fairfax, VA
08.2010 - 10.2010
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Followed informed consent processes and maintained records.
- Conducted Hepatitis C trials.
Clinical Research Coordinator
Anne Arundel Medical Center Research Institute
Annapolis, MD
09.2007 - 10.2009
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Conducted Oncology and Anticoagulant Studies.
Clinical Research Coordinator
DuPont Clinical Research
Rockville, MD
10.2001 - 09.2007
- High Enroller for 2 research studies on Major Depressive Disorder.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Gathered, processed, and shipped lab specimens.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Monitored unit budget to meet financial objectives for spend rate and funding.
- Conducted Central nervous system trials, and women's health.
Education
Master of Arts - Social Work
University of Maryland At Baltimore
Baltimore, MD, United StatesBachelor of Arts - Psychology
University of Maryland At Baltimore County
Catonsville, MD, United StatesSkills
- Outstanding Communication Skills
- Extreme Attention to Detail
- Multitasking and Organization
- Strong Work Ethic
- Team Collaboration
- Documentation & Reporting
- Electronic Medical Records
- Study Start Up
- Strong Knowledge of Medical Terminology
- Quality Control
- Adaptable
- Time Management
- Spreadsheet Tracking
- Telephone Etiquette
- Microsoft Office Suite
- Google Suite
Certification
Association Clinical Research Professionals Certified every 2 years since 2004.
Good Clinical Practice and ICH training every 2 years since 2001.
Cardiopulmonary Resuscitation (CPR)
Health Insurance Portability and Accountability Act (HIPAA)
Blood Borne Pathogens Certification
Phlebotomy Training
Timeline
Remote Clinical Research Coordinator II
Science 37
12.2020 - Current
Certified Clinical Research Coordinator
Investigative Clinical Research
05.2018 - 09.2020
Clinical Research Coordinator
Anne Arundel Medical Center (Now Luminus Health)
05.2016 - 04.2018
Clinical Research Coordinator
The Center For Sexual Wellness
06.2013 - 05.2016
Clinical Research Coordinator
Burke Internal Medicine
01.2011 - 06.2013
Clinical Research Coordinator (temporary)
Metropolitan Liver Disease/Gastroenterology Center
08.2010 - 10.2010
Clinical Research Coordinator
Anne Arundel Medical Center Research Institute
09.2007 - 10.2009
Clinical Research Coordinator
DuPont Clinical Research
10.2001 - 09.2007
Master of Arts - Social Work
University of Maryland At Baltimore
Bachelor of Arts - Psychology
University of Maryland At Baltimore County
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