Clinical Trial Management
Hi, I’m
Jamie Steed
Clinical Research Specialist
Raleigh,NC
There is a powerful driving force inside every human being that, once unleashed, can make any vision, dream, or desire a reality.
Tony Robbins
Summary
Result-driven clinical research professional with 7 years of extensive experience providing research support, coordination, and leadership for studies that involve NIH sponsored, investigator-initiated, and industry-sponsored Phase II and III clinical trials. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
7
years of professional experience
Work History
UNC-CH School of Medicine-Department of Psychiatry Research
Research Specialist
06.2021 - Current
Job overview
- Assisted Principal Investigators in the coordination and implementation of monitoring visits and study close-out visits
- Provided appropriate training and tools for study team members (new hires)
- Maintained the accuracy of DOA logs
- Documented date of training and signatures of study personnel trained on study-specific training logs
- Assisted PI to ensuring that all key personnel or persons 'engaged' in the research project have met training requirements in accordance with federal regulations and university policies and procedures.
- Established partnerships with external organizations to facilitate collaborative research recruitment efforts.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Maximized operational efficiency by developing and maintaining SOPs for various aspects of the clinical research process.
- Increased patient retention rates within studies by fostering strong relationships with participants and addressing their concerns promptly.
- Improved minority patient enrollment rates by effectively communicating the benefits and risks associated with participating in clinical trials.
- Managed enrollment timelines for multiple concurrent studies, ensuring recruitment is aligned with project goals.
- Facilitated effective communication between clinical monitors and sponsors ensuring timely resolution of issues that arose during trial execution.
- Reduced study deviations by implementing strict quality control measures and providing continuous feedback to clinical team.
- Conducted trials to evaluate the efficacy of drug treatments for depression.
- Developed and maintained courteous and effective working relationships.
- Acted as a team leader in group projects, delegating tasks and providing feedback.
- Identified issues, analyzed information and provided solutions to problems.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Developed strong communication and organizational skills through working on group projects.
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Exercised leadership capabilities by successfully motivating and inspiring others.
UNC Chapel Hill Department Of Psychiatry
Social/Clinical Research Coordinator
04.2017 - 06.2021
Job overview
- Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Streamlined data collection processes for increased efficiency and accuracy in study results.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Improved recruitment rates by developing and implementing effective patient outreach strategies.
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
- Reviewed referral information and kept track of intakes from various referral sources.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Gathered, processed, and shipped lab specimens.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Followed informed consent processes and maintained records.
- Skilled at working independently and collaboratively in a team environment.
- Resolved problems, improved operations and provided exceptional service.
- Worked flexible hours across night, weekend, and holiday shifts.
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Demonstrated respect, friendliness and willingness to help wherever needed.
Education
North Carolina Central UniversityDurham, NC
Bachelor of Science (BS) in Community Public Health Education
05.2016
Skills
- Research quality assurance
- Data entry and collection
- Regulatory compliance
- Project management
- Protocol adherence
- Knowledge of GCP and ICH Guidelines
- Submission of IRB and regulatory documents
- Drug maintenance and accountability
- Ensuring Informed consent process
- Entry of CRF data and verification of source data/documents (SDV)
- Use of electronic data capture (EDC) systems
- Reporting of serious adverse event (SAE)
- Facilitation and assistance with monitor SIVs and close-out visits
- Proficiency in scheduling
- Management of records
- Detailed documentation
- Understanding of research SOPs
- Subject recruitment and screening
- Strategies for recruitment and retention of subjects
- Compliance with patient safety and HIPAA regulations
- Organizational Skills
- Proficiency in Microsoft applications
- Phlebotomy skills
- Self-driven and motivated
- Attention to detail
- Adherence to deadlines
- Excellent time management skills
- Multitasking abilities
- Training and mentoring
- Analytical and Critical Thinking
- Troubleshooting skills
- Strong interpersonal and collaborative abilities
- Self-directed work style
Computer Technical
- Microsoft Office (Word, Excel, PowerPoint)
- Microsoft (365, One Drive, SharePoint, DropBox
- Outlook
- Trello
- EPIC
- Qualtrics
- ResearchforMe platform
Data Management Software
- ERT
- EDC
- IMedidata
- IRT
- Site Vault
- Qualtrics
- REDCap
- Medavante platforms
Additional Information
I have a list of ongoing and completed clinical trials which are mentioned below:
1. Personalized Integrated Chronotherapy for Perinatal Depression: PI- Dr. Samantha Meltzer-Brody November, 2020-present
2. Depression, Aging Stress and Heart Health Study (DASHH): PI- Dr. Margo Nathan, November 2022-present
3. Skylark Study (SAGE-217-PPD-301), Phase 3: PI- Dr.Meltzer-Brody February, 2021-May 2022
4. Robin Study (SAGE-217-PPD-201), Phase 2: PI- Dr. Meltzer-Brody, March 2018-March 2019
5. Chickadee Study (SAGE-547-PPD-304), Phase 3: PI- Dr. Meltzer-Brody, January 2020-May 2021
6. Hummingbird Study (SAGE-547-202B and 202C), Phase 3: PI- Dr. Meltzer-Brody, June 2017-September 2017
These trials are conducted to evaluate the safety and efficacy of various treatments for postpartum depression in women, including personalized integrated chronotherapy, Zuranolone, and SAGE 547. The trials are being conducted with the aim of improving the health and well-being of women suffering from postpartum depression.
Availability
See my work availability
Not Available
Available
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Affiliations
- ACRP
Interests
Clinical Research Associate Positions
Prevention Research
Cancer Research
Cardiology
Neurology
Diabetes
Infectious Diseases
Drug Trials
Device Trials
Accomplishments
- Achieved FDA approval for Zulresso infusion in the treatment of women with moderate to severe postpartum depression by completing SAGE-547 phase II and III clinical trials with team accuracy and efficiency.
- Achieved FDA approval for Zuranolone oral drug in the treatment of women with moderate to severe postpartum depression by completing SAGE-217 phase II and III clinical trials with team accuracy and efficiency.
Software
EDC
IRT
Medidata
ERT
Microsoft Applications
REDCap
Site Vault
OnCore
Qualtrics
Timeline
Research Specialist
UNC-CH School of Medicine-Department of Psychiatry Research
06.2021 - Current
Social/Clinical Research Coordinator
UNC Chapel Hill Department Of Psychiatry
04.2017 - 06.2021
North Carolina Central University
Bachelor of Science (BS) in Community Public Health Education