SAED ALSHAWABKEH
Metairie,LA
Summary
Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Supervisor Clinical Research Biospecimen and Core Research Laboratory
Ochsner (Baptist, Main campus Lafayette and Baton rouge)
2022.10 - Current
- Leader of clinical research team for execution of clinical studies according to ICH/GCP Guidelines
- Supervised various cancer clinical research studies ( biotechnology)
- Direct liaison with CRO's, pharmaceutical and biotech companies for execution of clinical studies
- Business manager, implementing accounting practices, cost, invoicing, and expenses for unit
- Designs clinical studies, including writing ICFs, protocols, CRFs, and patient facing materials
- Oversees clinical research operations and project management for low/high volume enrollment
- Cross-functional team leadership with various Ochsner, CRO and sponsor collaborators
- Oversees study start-up, including feasibility, contract initiation, budget negotiations, operations
- Manages core research processing/sendout laboratory according to standard laboratory practices and IATA shipping guidelines for clinical trials
- Collaborates with physician scientists to design and implement investigator initiated clinical studies
- Writes/designs standard operating procedures for centralization of clinical research and laboratory practices according to GCP, institutional policies, and standard laboratory practices
- Participates in Institutional Review Board review of clinical studies to be implemented by the team.
- Monitored workflow to improve employee time management and increase productivity.
- Observed packing operations to verify conformance to specifications.
- Maintained compliance with company policies, objectives, and communication goals.
- Resolved conflicts among team members promptly, maintaining a harmonious working environment conducive to productivity.
- Established performance metrics for the team, consistently tracking progress towards goals and making adjustments as needed.
- Collected, arranged, and input information into database system.
- Conducted performance evaluations for staff members, identifying areas of improvement and guiding professional development plans.
Clinical Research Coordinator
Med-pharma's (Now Velocity
2022.07 - 2022.09
- Obtain medical and concomitant medication history
- Take and record vital signs
- Perform ECGs and fibroscans
- Discuss and obtain informed consent with patient
- Collect, process, and ship specimen samples
- Make CRF entries, corrections, and manage queries
- Investigational product accountability.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Evaluated the efficacy of investigational products using rigorous statistical analysis techniques, informing critical decisions regarding product development or discontinuation.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Collected, evaluated, and modeled collected data.
- Gathered, processed, and shipped lab specimens.
- Complied with research protocols by providing ongoing quality control audits.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Followed informed consent processes and maintained records.
- Directed site initiation visits, establishing key partnerships with local healthcare providers to facilitate successful trial implementation.
Clinical Research Coordinator
Metropolitan Gastroenterology Associates dba GI Alliance, Metairie, LA (Now GI Alliance)
2020.12 - 2022.07
- Obtain medical and concomitant medication history
- Take and record vital signs
- Perform ECGs and fibroscans
- Discuss and obtain informed consent with patient
- Collect, process, and ship specimen samples
- Make CRF entries, corrections, and manage queries
- Investigational product accountability.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Collected, evaluated, and modeled collected data.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Conducted thorough literature reviews supporting the development of innovative study designs and methodologies.
General Practitioner/ Research Asscoiate)
"Dar Al Sheffa"Urgent Care Medical Comolex, Jordan
2012.11
- Diagnose and treat diseases and injuries in general practice
- Order or execute various tests, analyses, and diagnostic images
- Analyze reports and findings of tests and examinations
- Refer patients to medical specialists or other practitioners for specialized treatment.
Medical Assistant
Lakeview Family Medicine Care, Chicago Ridge, IL
2015.09 - 2019.09
- Provide care based on educational, physical, and social criteria
- Communicate patient needs to families and other staff members
- Complete documentation of patient related tasks.
Physician Internship
Royal Medical Services, Jordan
2010.02 - 2012.02
- Perform supervised duties in the following departments: General Internal Medicine, Pediatrics, General Surgery, and Gynecology and Obstetrics.
Education
MS Health Management -
Louisiana State University
Shreveport, LAMBBS (MD) -
Liaquat University of Medical and Health Sciences
01.2009
Skills
- Abnormality and Disease Detection
- Quality Improvement
- Care Plan Development
- Physical examination
- Medical chart documentation
- Patient examinations
- Electronic Medical Record Software
- Clinical Diagnosis
- Patient Assessments
- Staff Collaboration
- Medical record-keeping
- Medical Research
- Laboratory Testing
Licensure Certification
- 12/01/2020, Good Clinical Practice
- 06/15/2021, Fibroscan
- CPR
Clinical Research Experience
- 2019, Present, Gastroenterology (GI) and Hepatology Phases 2 - 4
- 2020, 2021, Study Clinical Research Coordinator, V-280, 280CLD, A Prospective, Randomized, Multi-center, Double-Blinded, Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Placebo, for the Treatment of Chronic Idiopathic Constipation
- 2022, Study Clinical Research Coordinator, Prelude, Prometheus Bioscience's, Inc, PRl00-105, A Study to Assess the Genotype of Subjects with Diagnosis of Ulcerative Colitis or Crohn's Disease
- 2021, 2022, Clinical Research Coordinator, Danube, FRENM-003, Freenome Holdings, Inc, Multi-Cancer and Comorbidity Blood Sample Collection for CrossReactivity Analysis for a Multiomics. CRC Screening Test
- 2022, Study Clinical Research Coordinator, NASH, 337HNAS20011, lnventiva S.A., A randomized, double-blind, placebo-controlled, multicenter, Phase 3 study evaluating long-term efficacy and safety of lamifiban in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) AND FIBROSIS 2 (F2) Fibrosis3(f3) stage of liver fibrosis.
- 2021, Clinical Research Coordinator, AMUC-2023, Salix, A phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC).
Certification
Good clinical practice
Languages
Arabic
Native or Bilingual
Timeline
Supervisor Clinical Research Biospecimen and Core Research Laboratory
Ochsner (Baptist, Main campus Lafayette and Baton rouge)
2022.10 - Current
Clinical Research Coordinator
Med-pharma's (Now Velocity
2022.07 - 2022.09
Clinical Research Coordinator
Metropolitan Gastroenterology Associates dba GI Alliance, Metairie, LA (Now GI Alliance)
2020.12 - 2022.07
Medical Assistant
Lakeview Family Medicine Care, Chicago Ridge, IL
2015.09 - 2019.09
General Practitioner/ Research Asscoiate)
"Dar Al Sheffa"Urgent Care Medical Comolex, Jordan
2012.11
Physician Internship
Royal Medical Services, Jordan
2010.02 - 2012.02
MS Health Management -
Louisiana State University
MBBS (MD) -
Liaquat University of Medical and Health Sciences
Good clinical practice
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