Clinical Research Coordinator III Job at Children's Hospital Los Angeles (Los Angeles)

Clinical Research Coordinator IV

PURPOSE AND SCOPE: Works under the supervision of the Principal Investigator (PI...

Location

United States of America , Denver

Salary:

Not provided

Fresenius Kidney Care Eupora

Expiration Date

Until further notice

Requirements

Bachelor’s Degree
Advanced Degree preferred or an equivalent combination of education and experience
Has excelled in the role of Clinical Research Coordinator III or equivalent for 5+ years and demonstrated a mastery of the job role, outstanding performance, and exceptional job performance measures
Clinical research site experience required
Clinical Research Coordinator certification (e.g., CCRC or CCRP) required
Current state licensure, if applicable
Excellent computer skills: Ability to adapt to various electronic systems
proficiency in Microsoft Office applications minimally
Excellent communication and organizational skills
Training/experience in management or other leadership roles is desirable

Job Responsibility

Works under the supervision of the Principal Investigator (PI) to support the conduct and management of a clinical study by facilitating and coordinating the daily study activities
Responsible for the collection, accuracy and validity of clinical research data for assigned clinical studies in accordance with the study protocol and timelines
Performs a variety of complex activities to appropriately compile, document and analyze clinical research data, using the subject’s medical record as source
Negotiates differing priorities with multiple players whilst balancing a multiple number of tasks and timelines under a complex network of rules and regulations
Ensures research studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and Food and Drug Administration (FDA) guidelines
Practices cost containment strategies while ensuring appropriate enrollment of subjects in studies
Complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal regulations
Adheres to Standard Operating Procedures (SOP), GCP, all regulatory practices as established by law, and company policies and procedures
Maintains essential trial documents according to applicable HIPAA and regulatory requirements
Works with dialysis facility manager and/or clinic manager to master standard of care procedures to better advocate on behalf of site research capabilities

What we offer

Healthcare
Continuing Education
Paid Time Off
Collaborative Environment
Additional Perks
401(k) Retirement Saving

Fulltime

Animal Health Clinical Research Associate III

At Argenta, we’re more than a company — we’re a global team, dedicated to health...

Location

United States , Shawnee

Salary:

Not provided

Argenta

Expiration Date

Until further notice

Requirements

8+ years clinical trial monitor experience within a Clinical Research Organization or major Animal Health pharmaceutical company
proven experience in GCP late phase clinical trials in animal health
attention to detail and analytically driven
dependability, flexibility and ability to multitask and manage time effectively
Minimum of 8 years’ experience in an animal health research role, Monitor and Clinical Research Associate positions preferred
Experience in Good Clinical Practice (GCP) data management, quality control, and/or quality assurance preferred
Collaborative working style. Lead and motivate people through influence across all levels and functions of the organization
Ability to look for creative solutions to resolve complex issues
Strong technical writing ability
Results oriented and driven

Job Responsibility

Coordinates and conducts GCP and study protocol training at study sites and assures training is documented
Builds rapport with study site staff to assure compliance with the protocol, applicable regulatory and guidance documents, SOPs, and all study activities
Assists in reviewing the study records and all study notebooks to ensure contents are current and complete
Assists in providing tracking and Quality Control (QC) of data as required and assists with responses to QA audits
Evaluates Investigators and assists with selection of appropriate sites to conduct clinical studies
Collaborates with the study Project Manager to assure study sites selected meet the needs of the study protocol
Monitors assigned study sites through review of electronic data capture (EDC) systems, faxed, emailed, and paper documentation
Serves as the liaison between Argenta US Clinical and study site personnel
Facilitates clarifications, corrections, and data query resolution with study sites or data management personnel
Tracks adverse events (AE’s) encountered in clinical studies and ensures all serious AEs and non-serious AEs are documented and communicated appropriately to the Project Manager and Sponsor

What we offer

strong culture
great benefits
opportunity for growth

Fulltime

Clinical Studies Coordinator III

Under departmental direction, coordinates activities to support multiple researc...

Location

United States , Winston Salem

Salary:

30.70 - 46.05 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Bachelor's degree with four years' experience as a clinical research coordinator
or an equivalent combination of experience and education
Master's degree preferred
SOCRA or ACRP Certification preferred
Must complete the CITI certification for Human Subject Research
All additional required WakeOne training for research coordinators
EPIC/WakeOne proficiency to include appropriate documentation of research notes
Good interpersonal and communication skills (verbal, non-verbal, and listening skills)
Proficient in the use of OnCore/WISER Clinical Trial Management System
Basic computer skills required

Job Responsibility

Coordinates activities to support multiple research studies of all phases and all levels of complexity
Serves as the principal administrative liaison for assigned studies and as a technical resource for the department
Develops and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations
Attends clinic as needed to perform activities including recruitment, administering questionnaires
Responsible for the compilation, registration and submission of data, as required by the Sponsor
Mentors and supports new and less experienced staff
Works under the direction of the Study Investigators or Clinical Research Nurse Manager with minimal supervision
Plays an active role in recruitment of patients to study
Performs protocol specific duties required per the research protocol
Obtains or assists the Principal Investigator in obtaining informed consent from subjects

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
Premium pay such as shift, on call, and more
Incentive pay for select positions
Opportunity for annual increases based on performance

Fulltime

Clinical Research Associate

CRA II, Home-based in Australia. ICON plc is a world-leading healthcare intellig...

Location

Australia , Sydney

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

18 months+ of monitoring experience in phase I-III trials as a CRA
Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data
Excellent written and verbal communication in English
Ability to produce accurate work to tight deadlines within a pressurized environment
Ability to travel at least 60% of the time (international and domestic -fly and drive)
Possess a valid driving license

Job Responsibility

Working independently and actively to coordinate activities to set up and monitor a study
Completing accurate study status reports and maintaining study documentation
Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested
Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required
Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness
Dependent on level of experience you may assist in training and mentoring less expert CRA's and/or lead CRA's working on international projects

What we offer

Competitive compensation package
Open and friendly work environment
Opportunities to develop long term career
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Program director iii oncology clinical trials office

The Program Director III has leadership responsibility for setting strategy, goa...

Location

United States , Winston Salem

Salary:

54.90 - 82.35 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Master’s degree with five years of progressive and applicable experience in the area served required
or an equivalent combination of education and experience
Significant experience and documented success in setting strategic directions and delivering on objectives is required
Excellent oral and written communication skills
Thorough knowledge and understanding of clinical research
Strong project and process management skills
Knowledge of program/project management techniques and methods
Excellent organizational and leadership skills
Highly self-motivated professional with ability to work under pressure with tight deadlines
Ability to achieve results with a high level of accuracy and attention to detail

Job Responsibility

Responsible for the overall administration and coordination of the day-to-day delivery of program services
Makes strategic decisions based on analysis and goals and objectives of assigned program
This includes managing all patient recruitment, screening, eligibility determination, and data generation according to each study’s protocols
Continuously analyzes systems and processes
Develops and implements best practices and appropriate changes to improve outcomes in a timely manner
Creates evaluation strategies to monitor performance and determines the need for improvements
Initiates and sets goals for programs according to the strategic objectives of the organization and leadership
Assists leadership in defining goals and strategic plans
Assists leader with budget development and planning
Ensures areas of responsibility meet fiscal requirements and monitors expenditures

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

Fulltime

Program director iii, oncology clinical trials office

The Program Director III has leadership responsibility for setting strategy, goa...

Location

United States , Winston Salem

Salary:

54.90 - 82.35 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Master’s degree with five years of progressive and applicable experience in the area served required
or an equivalent combination of education and experience
Significant experience and documented success in setting strategic directions and delivering on objectives is required
Excellent oral and written communication skills
Thorough knowledge and understanding of clinical research
Strong project and process management skills
Knowledge of program/project management techniques and methods
Excellent organizational and leadership skills
Highly self-motivated professional with ability to work under pressure with tight deadlines
Ability to achieve results with a high level of accuracy and attention to detail

Job Responsibility

Responsible for the overall administration and coordination of the day-to-day delivery of program services
Makes strategic decisions based on analysis and goals and objectives of assigned program
This includes managing all patient recruitment, screening, eligibility determination, and data generation according to each study’s protocols
Continuously analyzes systems and processes
Develops and implements best practices and appropriate changes to improve outcomes in a timely manner
Creates evaluation strategies to monitor performance and determines the need for improvements
Initiates and sets goals for programs according to the strategic objectives of the organization and leadership
Assists leadership in defining goals and strategic plans
Assists leader with budget development and planning
Ensures areas of responsibility meet fiscal requirements and monitors expenditures

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

Fulltime

Clinical Project Manager III

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelo...

Location

United States , Bedford

Salary:

135000.00 - 155000.00 USD / Year

werfen

Expiration Date

Until further notice

Requirements

Medical Technologist degree or BS in STEM is preferred
Minimum of 4 years experience in clinical project or research management
Minimum of 2 years' experience leading CRAs
Experience in design and development of medical instrumentation
Clinical Research Associate (CRA) certification or equivalent certification in project management is desired
Working knowledge of Good Clinical Practice (GCP) / Good Study Practice (GSP) as described by US Food and Drug Administration (FDA), World Health Organization (WHO), International Conference on Harmonization (ICH), and International Standards Organization (ISO)
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement
Problem solving, conflict management, listening, managing and measuring work
Strong project management skill set and familiarity with project management tools and techniques
Team player, self-motivated, perseverance

Job Responsibility

Provide technical and team leadership to one or more small clinical project team(s), including planning, scheduling, and technical leadership within the project area. Coordinate roles and responsibilities within the clinical project team
Responsible for clinical project planning and scheduling, utilizing deliverable milestone methods and critical path scheduling, and developing task and project estimates. At the Program Manager's, Clinical Research managers, or Clinical Director's request provide a schedule and budget forecast for the project
Responsible for conducting regular clinical project team status meetings and reviews. Plan and schedule technical reviews at appropriate clinical project milestones. Ensures deliverables are completed and documented according to Good Clinical Practice and per design control
Responsible for coordination of clinical project resources to identify the root cause(s) of clinical project issues, and develop and manage a plan to fix, test, and implement an appropriate solution through completion. If needed, coordinate with cross-functional team resources to support root cause initiatives
Responsible for insuring clinical project risks, both technical risks and management risks, are identified and appropriate risk mitigation plans are developed and executed. Track and respond to risk triggers. Regularly assess and report the status of overall clinical project risk to the development project team and Clinical Research Manager
Creates and maintains Trial Master File(s) and corresponding Design Control files to current study ensuring accuracy
Responsible for communication within clinical project team, development project team, and to clinical program management and department management. Develop and implement a project communication plan
Coordinates with study sites and internal service suppliers (i.e., Biobanking, Field Service Engineers, etc.) to ensure project deliverables are completed correctly and on time or that services are provided in accordance with the project plan
Able to identify and obtain support to resolve project team conflict. As necessary, work with development project leader to resolve cross-team conflicts. Able to remove oneself from the problem. Fosters creative, professional climate that will maximize the contributions of the multi-disciplinary clinical project team members
Participates in activities focused on improving the efficiency and effectiveness of the product development processes and procedures

What we offer

medical insurance
dental insurance
vision insurance
401k plan retirement benefits with an employer match
paid vacation
paid sick leave

Fulltime

Physician Support Rep III-Imaging Scheduling Operations

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

Location

United States , Rochester

Salary:

19.62 - 26.49 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

High School diploma and 2 years of relevant experience required
Or equivalent combination of education and experience

Job Responsibility

Performs complex secretarial and administrative duties in a fast-paced environment supporting clinical, educational, and academic programs
Responsible for all clinic preparations, including but not limited to providers' time and calendar management while optimizing provider-patient schedule, coordination of patient care, and information/data support
Serves as primary contact for provider(s)
Manages provider(s) calendar and prioritizes appointments and meetings based on provider preferences
Chooses and recommends among competing demands
Examines the clinical schedule(s) on a continuous basis to identify opportunities for optimizing the time and effort of providers
Finds missing orders and sends them for review and approval
Anticipates needs of insurance companies by gathering all necessary information for referrals and prior authorizations
Applies provider preferences and protocols in selecting multiple possibilities to execute and/or delegate follow-up actions based on the provider’s patient notes
Composes, edits, and obtains signatures for non-routine letters of correspondence related to appeals on denied claims, including compiling all necessary information and drafts for provider signature

Fulltime

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Clinical Research Coordinator III

Job Description

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Requirements

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