Sr. Quality Specialist, Clinical Quality Job at Baptist Health (Florida) (Jacksonville Beach)

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

New

Sr. Clinical Lab Scientist Specialist

The Senior Clinical Laboratory Scientist (CLS) Specialist independently performs...

Location

United States , San Diego

Salary:

128976.00 - 169984.00 USD / Year ▼

UC San Diego

Expiration Date

May 25, 2026

Requirements

Graduation from college with a major in an appropriate scientific field
possession of a clinical Laboratory Scientist’s license or a similar license of equal or higher level issued by the State Department of Health
four years of experience as a licensed Clinical Laboratory Scientist within the designated subspecialty
or an equivalent combination of education and experience
knowledge and abilities essential to the successful performance of the duties assigned to the position
Current California Clinical Laboratory Scientist license or appropriate subspecialty license issued by the California Department of Public Health
excellent verbal and written communication skills
able to articulate complex ideas to diverse audiences

Job Responsibility

Developing and modifying test procedures
conducting technical review and monitoring of existing procedures
coordinating quality control, quality assurance, and proficiency testing activities
identifying staff training needs
evaluating competency of testing personnel
serving as a technical consultant and resource for laboratory staff, the medical enterprise, and the community

Fulltime

Sr Clinical Research Data Specialist

Works in partnership with the primary point of contact to provide high quality, ...

Location

United States of America , Rochester

Salary:

24.91 - 34.87 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor’s degree Required
2 years of relevant experience Required
or equivalent combination of education and experience Required
Skill in completing assignments accurately and with attention to detail Required
Ability to understand and follow standard research protocols and procedures Required
Ability to process and handle confidential information with discretion Required
Possesses a working knowledge of key processes that encompass clinical trials (e.g., Regulatory and Finance), and how these processes are impacted by clinical trial data Required
Commitment to the University’s core values Required
Ability to work independently and/or in a collaborative environment Required
Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and Good Documentation Practices (GDP) Required

Job Responsibility

Assists in conducting quality checks of data accuracy with data source records as assigned
Perform data entry and verification tasks
Provides custom programming, statistical analysis, reporting and presentation graphics
Prepare and transfer data for analysis
Supports the implementation of custom, research project-specific data workflow solutions for data collection, management, reporting and analytics
Adheres to defined application development life-cycle practices
Consults with user departments and sites to assess data preparation and management needs, program design and testing
package selection and use of systems, software and equipment
Partners with the primary point of contact to provide data status reports and ensures protocol data objectives are scheduled appropriately
Answers a broad range of data clarifications for each study

Parttime

Process and Procedural Document Specialist, Sr. Manager

Parexel FSP is hiring a Process and Procedural Document Specialist, Sr. Manager ...

Location

Argentina; Brazil; Mexico , Remote; Remote; Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

A minimum of a BA or BS is required, advanced degree in relevant field desirable. Degree or professional certification in process design or change management, or equivalent experience
A minimum 5-8 years of experience in design and documentation of pharmaceutical business processes (safety, regulatory, medical and/or clinical). Demonstrated process development expertise
Ability to manage multi-phase moderately complex projects with multiple contributors/collaborators, facilitate cross functional global or enterprise teams, optimize subject matter involvement, and interacts at all levels in a matrix environment. Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines
strong planning and multi-tasking skills
Ability to lead by example, demonstrating the sponsor’ values and effectively implement strategies through influence and persuasion
Demonstrate ability to adapt to changing situations and work well under pressure
Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project)
tools for process design and mapping
and systems for document management, publishing, communication, and learning management
Understanding of the fundamentals of electronic publishing of procedural documents

Job Responsibility

Lead a matrix team comprised of global and/or local subject matter experts, business process owners, and key stakeholders, with minimal assistance, in the development, revision, process mapping, process enhancements, implementation and maintenance of process quality standards and procedural documentation (policies, SOPs and associated documents) for approximately 10,000 colleagues across the sponsor’ clinical, medical, safety, regulatory and enterprise quality management system global processes
Function as a key subject matter expert in the document management model, quality management system, and quality standards. Providing advice and recommendations to global and local colleagues on process enhancement and continuous improvement project teams. provide strategic recommendations regarding process design, documentation development, change management and supporting systems by understanding the business, organization and associated responsible roles
Plan and manage process development projects to address the full life cycle: requirements and policy setting
process design, documentation and training development and delivery
change management planning and deployment
and transition to an oversight system that incorporates performance monitoring and continuous improvement once the new/revised process is fully operational
Applies knowledge and understanding of global regulations in a GxP environment and produces processes and related documentation that meets regulatory requirements, supports corporate compliance, is inspection ready and is designed with operational effectiveness in mind and contains measurable controls where applicable
Identifies areas of training focus and collaborate closely with training developers on training strategies and plans
Contribute to compliance and audit/inspection readiness strategies and plans
Participate in regulatory inspections, external PV license partner audits, and other internal audits by being the liaison for documentation requests and responding to findings

Sr. Practice Manager

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

28.50 - 37.06 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Associate's degree preferably with coursework in business administration or health care administration required
3 years administrative experience required
2 years management experience in healthcare or an equivalent combination of education and experience
Electronic Medical Record (EMR) skills with expert proficiency in all aspects, including Master Scheduling and Billing knowledge required
Advanced knowledge of medical practices, terminology, and reimbursement policies required
Intermediate Microsoft Outlook email skills (open new, to, cc, send) required
Intermediate electronic filing skills (name a file, save file, save as) required
Advanced typing skills required
Advanced proficiency with Microsoft Word and Excel required
Travel to office sites required

Job Responsibility

Oversees the operational components of the 7 procedure rooms in the Cardiac Catheterization and Electrophysiology Lab and the 17 exam rooms in the Paul Yu Heart Center
In conjunction with clinical leadership, promotes operational efficiency, high quality, outstanding patient experience, and strong financial performance
Directs staff using the ICARE framework, promoting a collaborative, diverse, and professional team
Responsible for performance management of all non-clinical staff in the practice
Operations Management: Supervises the operation and implement procedures for enhancing levels of service and quality and enforces medical office policies and procedures for the Cardiac Cath and EP Lab and the Paul Yu Heart Center
Develop guidelines for prioritizing and assigning work activities, evaluating effectiveness and modifying processes as necessary
Establishes and maintains efficient and responsive patient flow system
Ensure proper registration and insurance pre-verification management processes are followed including warm transfers to centralized functions
Manages insurance prior authorization for procedures scheduled in the lab
Manages the hospital transfers from area hospitals to the lab and back to transferring hospital

Fulltime

Sr RCM Specialist

As the Senior RCM Specialist, you will partner with business leaders to improve ...

Location

United States

Salary:

24.93 - 31.17 USD / Hour

ATI Physical Therapy

Expiration Date

Until further notice

Requirements

High School Diploma, GED, or suitable equivalent
5 years of healthcare experience in clinical or office setting
3 years of healthcare revenue cycle experience
Offshore revenue cycle vendor experience
Excellent in Microsoft Office applications, capable of creating detailed analyses using pivot tables and other formulas/features within Excel
Strong attention to detail
Ability to prioritize and manage multiple tasks simultaneously
Excellent interpersonal and communication skills
Must have excellent organizational skills and ability to prioritize and coordinate workload

Job Responsibility

Partner with business leaders to improve and deliver positive change throughout all revenue cycle processes
Collaborate with the RCM supervisor, RCM Sr. Mgr./Mgr. to review the quality, efficiency, and productivity of vendor partners
Work to improve the accuracy and effectiveness of revenue cycle processes through leading account audits, data analysis, training sessions, and team/vendor meetings
Maintain ATI’s policies and procedures as it relates to focused area within the revenue cycle
Assist in the summarizing of audit data to identify process improvement opportunities and creating Service Level Agreement (SLA) quality reporting
Provide ongoing monitoring of standards by conducting audits
Perform timely reviews of patient accounts and remittances for denials to determine root cause
Provide subject matter guidance to ATI team members and offshore vendor partner teams
Prepare, schedule, and lead collaboration/training sessions
Monitor KPI & SLA metrics

Fulltime

Sr. Etrif Specialist

As a Trial Master File (TMF) Specialist II at ICON, you will ensure the accuracy...

Location

United States , Raleigh

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences, healthcare, or a related field
2+ years of experience in clinical trial operations or document management, with a focus on Trial Master File processes
Strong attention to detail and organizational skills
Excellent communication and interpersonal skills
Proficiency in electronic document management systems and an understanding of regulatory requirements related to TMF
Willingness to travel as required (approximately 5%)

Job Responsibility

Managing the quality and integrity of the TMF by ensuring timely and accurate document uploads and metadata management
Collaborating with cross-functional teams to identify and resolve discrepancies in TMF documentation
Conducting regular audits of the TMF to ensure compliance with regulatory requirements and internal procedures
Providing training and support to team members on TMF best practices and document management systems
Generating reports and metrics to track TMF status and provide insights for continuous improvement

What we offer

Various annual leave entitlements
A range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Fulltime

Sr. QA Specialist - Ops

The Sr. QA Specialist – External Operations will work with other departments to ...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

7-9 years of pharmaceutical or biotech industry
4+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Bachelor’s Degree in a relevant scientific discipline preferred
Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Ability to Travel 10%

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review process

Fulltime

Sr. Quality Specialist, Clinical Quality

Baptist Health (Florida)

Location:
United States , Jacksonville Beach

Category:
Health and Beauty

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 07, 2026

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