Carida Erwin
Newnan,United States
Summary
I am a highly skilled Clinical Research professional with 7 years of extensive experience in the United States.
My expertise encompasses all aspects of clinical research, from on-site and remote monitoring to supporting Phase II and III trials across diverse therapeutic areas. I have a proven track record of excelling in various types of visits, including SSV, SIV, IMV, and COV.
I possess a strong background in start-up activities, including facilitating feasibility, establishing site IRB approval, and collecting essential documents for regulatory filings. My dedication to advancing the field of clinical research and my desire to achieve new goals drive me to consistently deliver exceptional results and seek opportunities for professional growth.
Overview
8
8
years of professional experience
Work History
Clinical Research Associate
Accelsiors CRO
05.2022 - Current
- Provides regular status reports to the CTM according to study procedures, escalates sites and monitoring specific issues to CTM in a timely manner
- Maintains regular contact, via phone and/or email, with the sites to follow up study progress and support as required for all matters
- Documents and files these contacts into TMF
- Ensures investigator's compliance to protocol and initiates corrective action to resolve issues (with CTM input as needed)
- Attends regular internal project team meetings and external (e.g., client meetings) as required
- Performs regular site Interim Monitoring Visits (IMVs) according to Clinical Monitoring Plan and/or CTM/PM instruction and completes the site visit report and follow up letter within required timeframe
- Review investigational drug (IP) supply, storage, accountability, and destruction on site as applicable, throughout the duration of the study
- Ensure timely queries resolution with sites, in close collaboration with CTM and/or data management.
Clinical Research Associate/Clinical Trial Associate (Contract)
Nexus-Dx
01.2021 - 04.2022
- Assist the Project Manager and team by providing project control systems (e-TMF, enrollment tracking), delivery of Contract administration services, reporting to the client and participating in sponsor teleconferences, and Regulatory reporting and site updates on a regular basis
- Collaborate with monitors in the field for the tracking and managing of study documents for completeness and accuracy
- Prepare and maintain the Trial Master File (paper or electronic)
- Ensure that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCPs, and all applicable regulatory requirements for multiple sites
- Attentively manage study timelines
- Trustingly organize PSV, SQV, SIV, IMV and COV with sites.
Clinical Research Coordinator II
Atlanta Center for Medical Research
01.2020 - 01.2021
- Coordinate with Principal Investigator to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures
- Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study, while maintain documentation of training
- Assist Principal Investigator to assure that all key personnel or persons 'engaged' in the research project have met training requirements in accordance with federal regulations and sponsoring agency policies and procedures
- Prepare other study materials as requested by the PI
- These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs
- Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
Clinical Research Coordinator/RA
MedaPhase, Inc.
01.2020 - 09.2020
- Conduct or participate in the informed consent process, including answering any questions related to the study
- Obtains appropriate signatures and dates on forms in appropriate places
- Assures that amended consent forms are appropriately implemented and signed
- Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion
- Coordinate participant tests and procedures
- Collect data as required by the protocol
- Assures timely completion of Case Report Forms
- Coordinate with Principal Investigator to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures
- Attend investigator meetings as required or requested by the PI.
Clinical Research Coordinator I/II
Southern Clinical Research Associates
01.2017 - 01.2019
- Coordinate with Principal Investigator to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures
- Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study, while maintain documentation of training
- Collect data as required by the protocol
- Assures timely completion of Case Report Forms
- Maintain adequate inventory of study supplies, drugs, and devices
- Prepare other study materials as requested by the PI
- These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs
- Conduct or participate in the informed consent process, including answering any questions related to the study
- Obtains appropriate signatures and dates on forms in appropriate places
- Assures that amended consent forms are appropriately implemented and signed.
Clinical Research Coordinator
Women Under Study, LLC/NOLA Research Works
01.2016 - 01.2017
- Coordinate with Principal Investigator to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures
- Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study, while maintain documentation of training
- Establish and organize study files, including but not limited to, regulatory binders, study specific source documentation and other materials
- Assist Principal Investigator to assure that all key personnel or persons 'engaged' in the research project have met training requirements in accordance with federal regulations and sponsoring agency policies and procedures
- Prepare other study materials as requested by the PI
- These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs
- Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
Education
BA -
Southern New Hampshire University
01.2023
AS -
University of West Georgia, United States
01.2019
Skills
- Developing Study Tools
- Patient Recruitment Strategies
- Clinical Research Monitoring
- Data Evaluation
- Database Locking
- Quality Control
- Protocol Adherence
Therapeutic Experience
- Rare Disease: Dermatomyositis and Polymyositis
- Oncology: Breast cancer
- Hematology: Anemia
- Infectious Diseases: Sepsis
- Urology: Overactive Bladder
- Women's Health: Fibroids, Endometriosis, Contraception, Menopause and BV
- Gastroenterology: Ulcerative Colitis and Crohn's Disease
Timeline
Clinical Research Associate
Accelsiors CRO
05.2022 - Current
Clinical Research Associate/Clinical Trial Associate (Contract)
Nexus-Dx
01.2021 - 04.2022
Clinical Research Coordinator/RA
MedaPhase, Inc.
01.2020 - 09.2020
Clinical Research Coordinator II
Atlanta Center for Medical Research
01.2020 - 01.2021
Clinical Research Coordinator I/II
Southern Clinical Research Associates
01.2017 - 01.2019
Clinical Research Coordinator
Women Under Study, LLC/NOLA Research Works
01.2016 - 01.2017
BA -
Southern New Hampshire University
AS -
University of West Georgia, United States
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