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

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

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. 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. QA Specialist - Ops

The Sr. QA Specialist – Team Lead will work with other departments to ensure the...

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 participate in the management review process

Fulltime

Equity Sr. Research Associate - Biotech

Under general supervision of a Senior Equity Analyst, analyze and interpret clin...

Location

United States , New York

Salary:

80000.00 - 150000.00 USD / Year

Raymond James

Expiration Date

Until further notice

Requirements

Equivalent work experience or Ph.D/Md/PharmD required
Biochemistry, Neuroscience, or other life science focus strongly preferred
Business/Finance grads with some life science career experience also considered
Data analytics/coding skills preferred
Obtain the Series SIE, 86/87, and 63 licenses within one year from start date
General Experience - 6 to 10 years
Doctor of Medicine (MD) or MBBS (Required)
Doctor of Philosophy (PhD) or similar Doctorate Degree (Required)
Master's: Business Administration (Required)
Securities Industry Essentials Exam (SIE) - Financial Industry Regulatory Authority (FINRA)

Job Responsibility

Develops expertise on the biotechnology industry and individual biotech companies to assess the impact of clinical data readouts and other impactful news
Prepare and coordinate the completion of various data and analytics reports, including financial models for revenue and income forecasts, cash flow analysis, balance sheet, and quarterly projections
Assembles and analyzes clinical, scientific and other data to help inform investment ideas/ views on market outlook
Explores and develops a basic understanding of external developments or emerging issues and contribute to the evaluation of their potential impact on an investment recommendation
Build effective working relationships within the internal client organization, delivering high-quality professional services with guidance from senior colleagues
Develop own capabilities by participating in assessment and development activities as well as formal and informal training and coaching
gain or maintain external professional accreditation, where relevant, to improve performance and fulfill personal potential
Maintain an understanding of relevant technology, external regulation, and industry best practices through ongoing education, conferences, and reading specialist media

Fulltime

New

Ikea food

In the restaurant area, we ensure that our customers have several options, incre...

Location

Portugal , Almancil, Faro

Salary:

Not provided

IKEA

Expiration Date

Until further notice

Requirements

I like working in restaurants, in a team in a dynamic and collaborative way
I like customer contact and the desire to offer a good service that gives our customers a reason to return to IKEA more often
Ability to manage stress, sense of responsibility and ability to establish priorities and organize one's work efficiently
Flexible and receptive approach to change, with a proactive and entrepreneurial spirit, looking for new ways of doing things and improving the customer experience

Job Responsibility

Ensure a clean, organized and inviting work space
Work in the kitchen preparing and cooking dishes
Provide service in the customer restaurant, actively approaching the customer
Work in the co-workers restaurant
Work in the Bistro preparing delicacies and providing customer service
Work in the Swedish Grocery store providing customer service and managing the sales space
Contribute to safety, efficiency and good operational practices in accordance with current routines and food safety standards (HACCP)

What we offer

Co-workers Restaurant with diverse and healthy options at an affordable price
Schedules communicated in advance
Social and psychological support through the CÖNTIGO program
Annual bonus
Discounts and benefits in partnerships: gyms, technology, cosmetics, hotels, travel, etc.
Opportunities for ongoing online, in-class and on-the-job training

Parttime

New

Sales associate

The sales associate plays a key role in achieving high standards. You will be wo...

Location

Netherlands , Amstelveen

Salary:

Not provided

Calvin Klein

Expiration Date

Until further notice

Requirements

Previous experience within hospitality/retail
Good communication skills with the ability to build relationships easily
Team player who recognizes and celebrates the contributions and achievements of others
Ability to handle change, adapt quickly, and work with pace
Energetic and authentic with a clear presence on the shop floor
Approach problems with a 'can do' attitude and act with initiative to find solutions in the store
Hardworking
Interest in Fashion/Retail
Ability to work in a fast paced environment with ability to multi task in high pressure environments
Passionate to drive sales using digital platforms

Job Responsibility

Ensure high customer satisfaction through excellent service
First point of contact for authorizing discounts and resolving customer questions
Be a brand ambassador with in-depth product knowledge
Build and maintain professional relationships with customers
Put together outfits for customers and make further product recommendations
Assess customer needs and provide help and information on product features
Drive store KPIs and suggest improvements
Ensure shop and stock room maintenance, presentation and organization issues are addressed appropriately
Demonstrate in-depth product knowledge and possess successful link selling skills to drive business
Hold the ability to outfit build for customers

What we offer

Competitive and comprehensive benefits program that offers protection, peace of mind and flexibility
Commitment to fostering an inclusive and diverse community of associates with a strong sense of belonging

Parttime

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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