Focused Clinical Research Professional, well-versed in study protocols, standard operating procedures and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring more than10 years of related experience to a challenging new role.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Research Affiliation
Elligo Health
01.2023 - Current
Clinical Research Site Manager
Michigan Clinical Research Institute PC
06.2018 - Current
CTA and budgeting negotiation with sponsors
IRB Submission
Built successful workable environment through good communication and ensures coordinated workflow in study site.
Expanded 2 research sites and created 1 new site within 4 months of hire.
Increased revenue growth in 3 sites by increasing number of studies and improving recruitment metrics within 6 months of hire.
Responsible for managing day to day activity operations of clinical trials including scheduling study visits (SSV, SIV, IM, IMV, COV), Vendor Selection and providing oversight to research sites.
Participated in initiation visits and investigator meetings, implemented trials in accordance with study timelines and budgets.
Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
Performed IP shipment accountability and reconciliation and submit data change request when needed.
Monitored unit budget to meet financial objectives for spend rate and funding.
Maintained compliance with protocols covering patient care and clinical trial operations.
Collected data and followed research protocols, operations manuals and case report form requirements.
Created and Maintained ISF and worked with sponsor to keep up to date TMF
Followed informed consent processes and maintained records.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Gathered, processed and shipped lab specimens.
Led projects and analyzed data to identify opportunities for improvement and presenting recruitment metrics to management monthly.
Developed Standard Operating Procedures and maintained courteous and effective working relationships.
Resolved problems, improved operations and provided exceptional service.
Learned new skills and applied to daily tasks to improve efficiency and productivity.
Used coordination and planning skills to achieve results according to schedule.
Received and processed stock into inventory management system while ensuring each site has adequate supplies.
Collaborated with regulatory department to ensure submission timelines are met.
Managed team of employees, overseeing hiring, training and professional growth of employees.
Clinical Research Associate
ClinServ International
04.2017 - 08.2018
Site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out.
Partnering with the CTA to ensure overall site management while performing trial related activities for assigned protocols.
May contribute to process improvement and training
Assign clinical sites for a trial on diabetes
Train teams to comply with GCP principles
Conduct SAE reporting to sponsor CRO and IRB
Complete peer reviews of other CRAs to optimize performance
Report directly to the Clinical Project Manager for guidance
LQPPV (REMOTE)
Arriello S.r.o
04.2016 - 06.2018
Operating according to approved procedures (SOPs) and according to trainings by client.
Local literature screening.
Maintaining on ongoing basis an up-to-date and thorough understanding of the local regulatory and PV requirements as relevant to comply fully with the local PV obligations.
Notify clients with any change to the local pharmacovigilance requirements/legislation in timely fashion.
Receiving, archive and Following up on ADRs from the territory as required by local regulations guidelines and applicable SOPs.
Forwarding ADRs and any safety info to determined addresses, fax numbers or emails as pre agreed on with the sponsor.
Senior Clinical Research Coordinator)
PharmaquestJo
01.2014 - 03.2016
Served as a liaison between site personnel, investigators, and sponsors to ensure clear communication throughout the trial process.
Increased patient retention rates by establishing strong relationships with participants through effective communication and followup.
Implemented quality control measures across all areas of the study process to ensure accurate, reliable data collection and analysis.
Managed budgetary aspects of clinical trials, negotiating contracts with vendors and ensuring cost-effective resource allocation.
Senior Clinical Research Coordinator
ACDIMA BioCenter
04.2006 - 01.2014
Supervise Phase I and Bioequivalence unit studies
Contributed to the successful completion of numerous studies by coordinating all aspects of trial initiation, execution, and close-out activities.
Managed budgetary aspects of clinical trials, negotiating contracts with vendors and ensuring cost-effective resource allocation.
Served as a liaison between site personnel, investigators, and sponsors to ensure clear communication throughout the trial process.
Collaborated with investigators to develop innovative clinical trial designs, optimizing data collection methods for better results.
Education
Master of Science - Biology
Mutah University
Karak, Jordan
08.2005
Bachelor of Science - Animal Science
Mutah University
Jordan, Karak
08.2001
Skills
Multiple therapeutic expertise
Good communication and interpersonal skills
Reporting SAE and AEs
IATA trained (Local and Central lab sample processing)
Microsoft Office
Study protocols and ICF
Good Clinical Practices
Data Management (CTMS, EDC, EMR, ISF, TMF, IVRS)
Analytical and Critical Thinking
Multitasking Abilities
Problem-Solving
Vendor Management
CRO management
IP reconciliation and Accountability
Develop operating procedures (SOP ) and ensure that the entire research team follows those procedures
Certification
Certified Clinical Research Professional, Society of Clinical Research Associates (SOCRA)
ATA certificate GCP certificate
International Computer Driving License (ICDL)
Microsoft office skills
SPSS & SAS Analysis
Accomplishments
Collaborated with the Central Business Office in the development of quarterly Key Performance Indicators to track site improvements.
Supervised team of over 10 staff members.
Used Microsoft Excel to develop ongoing studies tracking spreadsheets.
Documented and resolved queries timely which led to complete and accurate data collection.
Created Quality Control team to carry out internal audit within the department.