Clinical Laboratory Specialist Job at Connexion Systems & Engineering, Inc (San Marcos)

Clinical Laboratory QA Specialist

The Clinical Laboratory QA Specialist is responsible for many quality aspects in...

Location

United States , Madison

Salary:

74000.00 - 122000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific major or related field and 2+ years of experience in quality assurance (or quality management system) in a regulated environment
or high school degree/general education diploma and 4+ years of relevant experience with at least 2 years in quality assurance (or quality management system) in a regulated environment in lieu of Bachelor’s degree
Demonstrated ability to collaborate across functions and with both internal and external stakeholders, and to communicate ideas and opinions in a proactive and professional manner
Demonstrated understanding of specific state regulatory requirements for clinical laboratory operations, such as California, New York, Maryland, or Florida
Demonstrated understanding of FDA, CLIA, CAP, HIPAA, or other regulatory body
Proficient in Microsoft Office programs
Demonstrated aptitude for learning new software
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis.

Job Responsibility

Support the monitoring and maintenance of policies and procedures to ensure the clinical laboratory meets respective standards and regulations
Generate laboratory-based metrics to measure efficacy of the quality system and prepare periodic metrics reporting for management oversight
Review and document non-conforming events, conduct investigations, perform root cause analysis, and develop and assist with implementation of corrective and preventive actions
Provide assessment, quality input and guidance, investigational support, and resolution for end-user feedback
Review, investigate, evaluate, and maintain patient medical records
Assist in monitoring effectiveness of the quality management system and provide visibility through data and metric reporting
Interact with representatives from the customer care center for follow-up and assist in gathering documentation to support feedback escalations
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
Support and comply with the company’s Quality Management System policies and procedures
Maintain regular and reliable attendance

What we offer

Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Bonus eligibility.

Fulltime

Clinical Laboratory Compliance Specialist

Department: 60947 Wake Forest Baptist Medical Center - Lab: Compliance POC Q & S...

Location

United States , Winston Salem

Salary:

24.10 - 46.05 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Bachelor's degree in clinical laboratory science from an accredited institution or a bachelor's degree in a Chemical, Physical, or Biological Science required
Five years' clinical laboratory experience required
ASCP preferred
Specialty certification preferred
Master's degree (MBA, MHA, Masters in a Chemical, Physical, or Biological Science) preferred

Job Responsibility

Assists with the coordination, development, implementation, and evaluation of a compliant laboratory program for all entities of Wake Forest Baptist Health
Develops policies and procedures to address regulatory requirements
Works collaboratively with lab and hospital leadership
Develops and coordinates required training and competency assessments
Provides assistance to areas with CMS-116 CLIA notification forms
Provides consultative support regarding interpretation and implementation of regulatory standards
Monitors all ECRI and Recall alerts pertaining to the laboratory
Monitors Quality Assurance (QA) activities for testing sites
Provides consultative support for Proficiency Testing needs
Prepares for and participates in all applicable accreditation inspections

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program
Opportunity for annual increases based on performance
Premium pay such as shift, on call, and more
Incentive pay for select positions

Fulltime

Clinical Laboratory QC Specialist

The Clinical Laboratory Quality Control (QC) Specialist I performs and functions...

Location

United States , Madison

Salary:

76000.00 - 125000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in chemical, biological, or clinical laboratory sciences or medical technology from an accredited institution
For a degree not one of those listed above: 90 semester hours which must include 16 semester hours in chemistry (6 of which must be in inorganic chemistry)
16 semester hours in biology courses and 3 semester hours of math
2+ years of experience in a laboratory setting
1+ years of experience performing, reviewing and understanding quality control on a routine basis
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Authorization to work in the United States without sponsorship

Job Responsibility

All assigned job duties are performed following laboratory policies and procedures
Responsible for running daily QC scripts using statistical software and reviewing generated daily QC data
Responsible for identifying quality control issues, errors, and trends and promptly informing QC Specialist II and/or other QC team members of issues identified
May be requested to assist QC Specialist II and/or other QC team members in investigation of quality control issues, errors, and trends
May be requested to assist QC Specialist II and/or other QC team members in preparation of monthly quality control reports
Responsible for performing validations, verifications, and studies under the guidance of the QC Specialist II and/or other QC team members
Responsible for obtaining validation, verification, and study data for review
May be requested to assist in review of validation, verification, and study data
Assists QC Supervisor, QC Lead, and other QC team members in ensuring that all section turn-around times are maintained
Assists the QC Supervisor, QC Lead, and other QC team members by escalating concerns and answering technical questions from laboratory staff and others in Exact Sciences labs, as appropriate

What we offer

paid time off (including days for vacation, holidays, volunteering, and personal time)
paid leave for parents and caregivers
a retirement savings plan
wellness support
health benefits including medical, prescription drug, dental, and vision coverage
bonus eligible

Fulltime

Clinical Support Specialist

We are looking for a detail-oriented Clinical Support Specialist to support pati...

Location

United States , Palo Alto

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Exceptional attention to detail and accuracy
Strong verbal and written communication skills
Ability to manage multiple tasks in a fast-paced environment
Strong customer service and problem-solving abilities
Ability to work independently while maintaining high quality standards

Job Responsibility

Accurately log and process incoming patient samples and test orders
Enter complex laboratory orders into specialized software systems
Provide support and troubleshooting assistance to physicians and healthcare providers regarding test orders
Compile meeting agendas and assist with administrative coordination
Maintain and organize paper-based filing systems and documentation
Ensure data accuracy, completeness, and compliance with established procedures
Handle sensitive patient and healthcare information with confidentiality and professionalism

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

Fulltime

Clinical Study Specialist

Clinical Study Specialist ICON plc is a world-leading healthcare intelligence a...

Location

United States , Basking Ridge

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Must have a Bachelor's Degree
Must have a minimum of 2 years industry related work experience
Experience supporting global trials (NA, LAM, EU, APAC, India)
Experience working in TMF, CTMS, Sharepoint
Excels in written and verbal communications
Self-starter, can work independently with minimal oversight, solution-oriented
ICF review experience
General competency: powerpoint/excel skills, meeting minutes
Vendor management/oversight experience a plus
Must be open to hybrid office/home based in Warren NJ, Armonk NY or Cambridge MA

Job Responsibility

Organizes and delivers analyzable reports and metrics to the clinical study lead
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
Collates data for assessments such as feasibility and site selection and reviews site usability database
Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
Collates materials for training and investigator meetings
Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Clinical Study Specialist

Clinical Study Specialist (office based). ICON plc is a world-leading healthcare...

Location

United States , Boston; Basking Ridge, NJ

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Must have a Bachelor's Degree
Must have a minimum of 2 years industry related work experience
Experience supporting global trials (NA, LAM, EU, APAC, India)
Experience working in TMF, CTMS, Sharepoint
Excels in written and verbal communications
Self-starter, can work independently with minimal oversight, solution-oriented
ICF review experience
General competency: powerpoint/excel skills, meeting minutes
Vendor management/oversight experience a plus
Must be open to hybrid office/home based in Warren NJ, Armonk NY or Cambridge MA

Job Responsibility

Organizes and delivers analyzable reports and metrics to the clinical study lead
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
Collates data for assessments such as feasibility and site selection and reviews site usability database
Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders)
Collates materials for training and investigator meetings
Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Senior Clinical Research Specialist

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

Location

United States of America , Rochester

Salary:

60431.00 - 84603.00 USD / Year

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 3 years of relevant experience required
Ability to effectively manage complex research protocols/procedures required
Fully adheres to applicable safety and/or infection control standards
Proficiency in medical terminology, the clinical research process, and applicable regulatory guidelines, standards preferred
Proficiency in managing multiple and competing priorities/demands
Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, and OSHA guidelines throughout study implementation
Exceptional interpersonal, organizational, and time management skills
highly collaborative, promotes teamwork
Ability to build collaboration among research team members, laboratory staff, patients, and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients)
Proficient in MS Office (e.g., Word, Excel, and PowerPoint), email, and internet

Job Responsibility

Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols
Manages the day-to-day operations of multiple studies, carrying out study coordination duties from protocol development and initiation through to study close-out in accordance with regulatory/sponsor guidelines
Monitors and maximizes adherence to research standards, regulatory guidelines, and approved operational procedures
Works closely with study team members and other study sites to ensure the safety and adherence of study participants to the study protocol
Manages study-related administrative and human resources tasks and facilitates across-the-board flow of information, orchestrating study activities and personnel
Coordinates enrollment of participants
Oversees and facilitates eligibility screening and study recruitment activities
Plans study timelines and schedules appointments and study visits
Manages and organizes case report forms, source documents, and research records
Enters research data into data collection forms and/or study databases

Fulltime

Clinical Study Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , Warren, NJ or Cambridge, MA

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Must have a Bachelor's Degree
Must have a minimum of 2 years industry related work experience
Experience supporting global trials (NA, LAM, EU, APAC, India)
Experience working in TMF, CTMS, Sharepoint
Excels in written and verbal communications
Self-starter, can work independently with minimal oversight, solution-oriented
ICF review experience
General competency: powerpoint/excel skills, meeting minutes

Job Responsibility

Organizes and delivers analyzable reports and metrics to the clinical study lead
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
Collates data for assessments such as feasibility and site selection and reviews site usability database
Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
Collates materials for training and investigator meetings
Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

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Clinical Laboratory Specialist

Job Description

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