Ruth Jay
Indianapolis,IN
Summary
Experienced CRA III who has performed monitoring and site management activities in several therapeutic areas, adept at recognizing clinical values and abstract data from source documents, monitoring progress of clinical projects at assigned investigative/physician sites, ensuring clinical projects are conducted, recorded and reported in accordance with the protocol, company and sponsors standard operating procedures (SOPs) & ICH-GCP.
Overview
12
12
years of professional experience
Work History
CRA III
PRA Health Sciences
Raleigh, NC
05.2019 - Current
- Performs study initiation activities, Interim and study close-out visits while reviewing regulatory documents, as well as provide training on completion of the eCRF to site staffs.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site and remote monitoring visits.
- Performs study close-out visits per the study specific Clinical Monitoring Plan, including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
- Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and on-site source verification, while working with sites to resolve data queries.
- Identified adverse events and reports per protocol guidelines. Assisted in the planning and design of source documents for study protocols as required.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS).
- Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor, while also performing investigational product inventory by ensuring the return of unused materials to designated location or verify their destruction as required by the sponsor.
- Facilitates effective communication between investigative sites, the client company and the project team through written, oral and/or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Contributes to other project work and initiatives for process improvement, as required.
- Monitoring Visit Report (MVR) review, management, resolution and escalation as required.
CRA II
DP Clinical
Rockville, MD
01.2017 - 05.2019
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Ensured sites are familiar and proficient with protocol and study procedures.
- Executed site close-out monitor and archived all procedure files and data results at each site according to SOP and GCP requirements.
- Executed site training, including protocol, study SOPs, site files and records, database and date entry requirements, and tested workflow training.
- Monitored site proficiency testing and pre-study testing.
- Ensured sites are familiar and proficient with protocol and study procedures.
- Understood and applied knowledge regarding local, state, and country regulations and industry guidelines.
- Knowledge of electronic systems e.g., e-CRF, electronic Trial File Master (e-TMF), and Clinical Trial Management System (CTMS).
- Was responsible for attending all required training, study-specific training, and assisting in training of other co-workers.
CRA I
DP Clinical
Rockville, MD
03.2015 - 07.2017
- Presents trial information at Site Initiation Visits or Investigators meetings.
- Assists in the preparation and follow-up of in-house and on-site sponsored quality audits, as well as regulatory authority inspections.
- Coordinates project meetings and assists in the support or maintenance of clinical trial timelines.
- Managed and monitored studies involving multiple vendors and coordinated data verification and query resolution across all vendors.
- Identified clinical-study aberrations (primarily severe and/or unexpected health issue volunteers experienced) and ensured the timely and accurate documentation, follow-up, and reporting.
- Monitored studies utilizing various EDC systems (Medidata Rave, RDC, Inform) and various reporting systems such as Impact my sites and CTMS.
- Assists with development/review of study documents, including clinical trial protocols, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and lab manuals.
- Conducts data review to ensure a clean and complete clinical database.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
Clinical Research Coordinator
IUPUI
Indianapolis, IN
01.2013 - 03.2015
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- 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.
- Offered friendly and efficient service to customers, handled challenging situations with ease.
Education
Bachelor of Science - Economics
University of Ibadan
Therapeutic Summary
Oncology: (5 years) Lung 5 Phase III, Multiple Myeloma 3 Phase I/II, Lymphoma 3 Phase I/III, Multiple solid tumors dose finding and Escalation Phase II
Ophthalmology: Glaucoma Phase I/II,Diabetic Retinopathy Phase III.
Neurology/CNS: Schizophrenia Phase I/II, Huntington Disease Phase I/II, Parkinson Disease phase III
Infectious Diseases: (3 years) Flu Phase III, (2 years) Cystic Fibrosis Phase III
Medical Devices. (10years) Heart value, CGDM, EMR, EER, IVD, REDCap
Cardiovascular (4.5years) Hypertension, Myocardial Infraction
Timeline
CRA III
PRA Health Sciences
05.2019 - Current
CRA II
DP Clinical
01.2017 - 05.2019
CRA I
DP Clinical
03.2015 - 07.2017
Clinical Research Coordinator
IUPUI
01.2013 - 03.2015
Bachelor of Science - Economics
University of Ibadan