Jo Sheloan Jordan
Durham,NC
Summary
With over eight years of increasing experience and responsibilities at Thermo Fisher Clinical Research, I am an accomplished Clinical Research Associate Assistant who excels at improving patient safety, directing site operations, and ensuring quality assurance. Successfully manages site evaluations, initiations, closeouts, regulatory document collection, and in-house monitoring, among other tasks. Experienced in oncology and neurological study trials, as well as pharmacovigilance and clinical research coordination. Diligent in conducting studies in compliance with acceptable clinical practices and study-specific quality standards. My proactive approach and meticulous documentation ensure excellence in all aspects of clinical studies. While advanced planning, problem-solving, and communication skills contributed to my clinical research success.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Assistant Clinical Research Associate
Thermo Fisher Clinical Research
03.2022 - Current
- Serves as the primary study contact for an average 20 Oncology and Neurological studies within US and Canada.
- Maintains site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviews clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducts in-house initiation, monitoring and closeout activities to verify study procedures, regulatory documents and data completion.
- Collaborates with cross-functional teams to successfully meet project timelines and deliverables.
- Implements electronic data capturing systems to adhere with clinical research guidelines and Good Clinical Practices (GCP).
- Trains, monitors progress, and answer queries while providing guidance during the course of a clinical study.
- Oversee consent procedures to comply with local and federal regulations.
- Liaises with clinical project leader to effectively resolve study-related issues.
- Facilitates timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
- Gathers and organizes clinical trial documentation to meet rigorous standards for site approval.
- Conducts meetings with sponsor representatives to discuss clinical study developments.
- Collaborates with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Adheres to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
- Maintained confidentiality of patient information according to HIPAA guidelines while communicating effectively with team members about critical updates.
MEDICAL INFORMATION ASSOCIATE II
Thermo Fisher Clinical Research
04.2021 - 02.2022
- Identified, and triaged adverse events and product complaints tailored by clinical trial information, client-approved resources, medical literature, and procedural requirements.
- Responded accurately and professionally to technical and medical information inquiries received via phone, email, internet, or mail in reference to pharmaceutical or device product complaints and medical adverse events.
- Formulated accurate and concise responses according to client-approved resources, medical literature, clinical trial information and procedural requirements.
- Recorded all inquiries and interactions with subjects, sponsors and site management in appropriate databases according to organizational, client and regulatory guidelines.
- Acquired thorough knowledge of project and corporate policies and procedures including client products, Standard Operations Procedures (SOPs), protocols, Good Clinical Practices (GCPs), and applicable regulatory requirements.
- Managed multiple competing priorities effectively while adhering to deadlines, resulting in consistently high-quality results.
- Facilitated cross-functional communication by serving as a liaison between sponsors, site management, regulatory agencies and company policies.
- Developed expertise in various software applications, such as electronic Trial Master File (eTMF), Clinical Trial Management System (CTMS), and Veeva Vault for versatility and efficiency for good organizational demands.
- Enhanced data accuracy by implementing efficient information management systems and processes.
- Reduced data entry errors by 95% by implementing quality control measures and thorough review processes.
- Ensured compliance with all relevant legal regulations concerning information privacy and protection at all times.
- Trained new Medical Information Associates (MIA), sponsors, project members on company-specific databases, tools, processes and PPD and Client/Sponsor regulatory guidelines.
- Transcribed and entered patient medical information into electronic medical records systems.
- Followed exact procedures for handling transfers and other releases of medical records.
- Provided additional support and follow-up as often to ensure data accuracy and validity.
MEDICAL INFORMATION ASSOCIATE I
Thermo Fisher Clinical Research
10.2015 - 04.2021
- Provided technical and medical information, and/or performed intake of adverse events or product complaints with quality customer service.
- Answered over approximately 25 calls per day while consistently surpassing operational targets and deadlines.
- Contributed to enhanced customer satisfaction by providing accurate, up-to-date information promptly upon request.
- Accelerated ability to train and implement procedures quickly and accurately.
CERTFIED NURSING ASSITANT (CNA) II
MAXIM HEALTHCARE SERVICES
01.2011 - 04.2015
- Reported directly to the Registered Nurse.
- Assisted patients with daily living activities, promoting independence and dignity.
- Monitored patient vitals such as temperature, blood pressure, and blood glucose levels.
- Promoted good oral and personal hygiene by aiding patients with shaving, bathing, teeth brushing and oral suctioning.
- Enhanced patient satisfaction by providing compassionate and attentive care.
- Documented medications and treatment administration on the medication administration record.
- Noted pertinent patient information such as physician contact, care activities and observations in the electronic health record.
- Administrated and regulated oxygen levels through nasal cannula for patients.
- Measured and recorded pressure ulcers while maintaining skin and wound care.
- Aided with sterile methodology.
- Answered call lights and supported patient comfort and safety by adjusting bed rails and equipment.
- Gained intermittent and continuous internal tube feeding experience.
- Delivered individualized patient care by recording vital signs, documenting observations, administering treatments, and evaluating patient needs.
- Provided emotional support for patients during challenging times, fostering a positive healing environment.
- Reduced patient stress levels through effective communication and active listening skills.
- Promoted infection control practices within the facility by adhering to strict hand hygiene procedures and utilizing personal protective equipment when necessary.
- Documented patient information and care activities in electronic health record.
- Assisted nursing staff with completing daily rounds, documenting vital signs and answering calls.
- Helped patients with self-feeding and assisted feeding, based on individual needs.
Education
High School Diploma -
Riverside High School
Durham, NC05.2005
Some College (No Degree) - Journalism
NC A&T State University
Greensboro, NCSkills
- Site Management
- Pharmacovigilance
- Coordinating site operations
- Informed Consent Process
- Adverse event reporting
- Patient Safety
- Report Writing
- Status Reporting
- Clinical Research Coordination
- Records Maintenance
- Good Clinical Practices
- Quality Assurance
- Detailed documentation
- Source Document Verification
- Quality Control
- Medical Writing
- Research SOPs understanding
Affiliations
- Chaplaincy
Certification
- License - [Timeframe]
- Certified Nursing Assistant I & II - 2014
Timeline
Assistant Clinical Research Associate
Thermo Fisher Clinical Research
03.2022 - Current
MEDICAL INFORMATION ASSOCIATE II
Thermo Fisher Clinical Research
04.2021 - 02.2022
MEDICAL INFORMATION ASSOCIATE I
Thermo Fisher Clinical Research
10.2015 - 04.2021
CERTFIED NURSING ASSITANT (CNA) II
MAXIM HEALTHCARE SERVICES
01.2011 - 04.2015
High School Diploma -
Riverside High School
Some College (No Degree) - Journalism
NC A&T State University
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