Donelly Ike
Houston
Summary
Knowledgeable background in clinical research with experience being in the field for 6 years. Official certification of experience with ACRP. Experienced with numerous therapeutic areas of research including oncology, psychology, cardiovascular and infectious diseases.
Overview
9
9
years of professional experience
Work History
Clinical Research Associate
Auris Health
01.2023 - 05.2025
- Authored and reviewed visit reports, trip notes, and follow-ups with 100% on-time documentation submissions.
- Monitored early phase (phase 1 & II) studies in medical devices involving operating room devices
- Study start-up and study conduct activities including drafting ICF study specific templates, study IRB submissions, and drafting TMF documentation plans
- Assessed safety reporting requirements for each study, ensuring proper documentation and notification procedures were followed per adverse event or device deficiency
- Lead meetings for cross-functional team to coordinate and implement processes for team site evaluation visits, site communications, device setup, install, and device accountability.
Clinical Research Associate
Icon plc
06.2020 - 01.2023
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to project team and with guidance develops action plans
- Conducted more than 100 on-site monitoring visits for studies in therapeutic areas such as IVD for early detection of colorectal cancer, CAR-T cell therapy for T cell receptor modification targeting cancer cells, portable ekg devices for early indication of stroke, phase III studies for hyperlipidemia etc
- May perform investigational product (IP) inventory, reconciliation , IP accountability, and reviews storage and security
- Verifies IP has been dispensed and administered to subjects/patients according to protocol
- Verifies issues or risks associated with blinded or randomized information related to IP
- Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labeled, imported and released/returned
- Reconciles contents of ISF with electronic Trial Master File (eTMF)
- Ensures investigator/physician site is aware of requirement of archiving essential documents in accordance with local guidelines and regulations
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan
Clinical Research Coordinator
Austin Regional Clinic, WCG
01.2020 - 06.2020
- Unblinded coordinator for Covid-19 vaccine studies
- Prepared IP by following IP manual procedures while also administering vaccine or placebo for double-blinded studies.
- Randomize subjects via IRT and update eCRFs with every subject enrolled
- Engage in virtual meetings with unblinded monitors for updates on inventory and IP accountability.
Clinical Research Coordinator
Baylor University Medical Center
08.2017 - 01.2020
- Maintain essential documents on investigator site level
- Gathered, processed, and shipped lab specimens such
- Prepare documents for ICF of subjects and ensure ICF is up to date
- Ensure compliance of protocol for oncology studies at site level
- Record AE's and escalated report per regulatory guidelines if AE is serious
- Assess inclusion and exclusion criteria with subjects with PI oversight.
- Followed informed consent processes and maintained record in subject files.
Research Associate Intern
Urgent Care Clinical Trials
03.2016 - 08.2017
- Builded foundation on knowing what clinical trials are
- Gain knowledge in clinical research terminology
- Familiarize roles and responsibilities of each role in clinical research
- Perform quality checks to ensure all documents in charts are completed and signed
Education
Certification - CCRC
ACRP
Austin, TX03.2021
Bachelor of Science - Biology
The University of Texas At Arlington
Arlington, TX12.2015
Skills
- Informed Consent
- Good Clinical Practice
- Study Monitoring
- Trip Reports
- eTMF upload and review
- Data Collection
- Action Planning
- Database Locking
- Specimen Collection
- Reporting Adverse Events and Device Deficiencies
Timeline
Clinical Research Associate
Auris Health
01.2023 - 05.2025
Clinical Research Associate
Icon plc
06.2020 - 01.2023
Clinical Research Coordinator
Austin Regional Clinic, WCG
01.2020 - 06.2020
Clinical Research Coordinator
Baylor University Medical Center
08.2017 - 01.2020
Research Associate Intern
Urgent Care Clinical Trials
03.2016 - 08.2017
Certification - CCRC
ACRP
Bachelor of Science - Biology
The University of Texas At Arlington
Similar Profiles
Shravani MedakShravani Medak
SAP PP/MM HANA Consultant at AURIS HEALTHSAP PP/MM HANA Consultant at AURIS HEALTH
Margaret LaBarberaMargaret LaBarbera
Senior Director Marketing Communications at Eko Health Inc.Senior Director Marketing Communications at Eko Health Inc.
MOHAMMAD JASIM ALAMMOHAMMAD JASIM ALAM
Front office associate at AURIS BOUTIQUE HOTEL APARTMENTSFront office associate at AURIS BOUTIQUE HOTEL APARTMENTS
Jennifer PickardJennifer Pickard
Purchasing and Operations Coordinator at Grace InstrumentPurchasing and Operations Coordinator at Grace Instrument
Anish RaghavanAnish Raghavan
Marketing Intern at TULU ltdMarketing Intern at TULU ltd