Clinical Studies Coordinator III Job at Advocate Health Care (Winston Salem)

Clinical Research Coordinator III

The Clinical Research Coordinator III, as a certified research professional, han...

Location

United States , Los Angeles

Salary:

75712.00 - 129792.00 USD / Year

Children's Hospital Los Angeles

Expiration Date

Until further notice

Requirements

5+ year experience in clinical trial coordination
2+ years pediatric clinical trials experience
Oncology experience preferred
Pediatrics experience preferred
Study start up experience preferred
Bachelor’s degree or associates degree in related scientific field
ACRP Certified Clinical Research Coordinator (CCRC) or SOCRA Certified Clinical Research Professional (CCRP)
Candidates with a medical degree are exempt from certification requirement

Job Responsibility

Handles clinical trial administration for all protocol phases
Serves as a resource for study team members and principal investigators
Assists with subject recruitment, data collection, scheduling of study-related activities and follow-up with enrolled subjects
Works with faculty in development of investigator-initiated studies
Assists in quality assurance/control of data resulting from studies
Provides cross-coverage for other CRCs within the department
Trains new staff
Develops procedures related to clinical trial coordination
Manages submission of regulatory documents in accordance with IRB, federal, industry, and institutional guidelines and requirements

What we offer

Competitive compensation package
Robust benefits program

Fulltime

Administrative Coordinator III

With minimum direction and considerable latitude for independent judgment, works...

Location

United States of America , Rochester

Salary:

18.65 - 26.11 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

College graduation or an equivalent combination of experience and training
1 year of relevant administrative experience
Proficient in MS Word, MS PowerPoint, MS Outlook, MS Excel, and Windows 7
Proficient in navigating through internet and, in general, a technophile that can easily learn to use new technological platforms as the program needs dictate
Knowledge of MS SharePoint
Knowledge and proficiency of Kentico (U of R website program)
Knowledge of UR Student
Knowledge of Procure to Pay
Responsible, self-directed, and customer service-oriented, with strong organizational skills and capability to triage operations-related situations
Capable of drafting communications that are grammatically correct, properly proofread, and effective, as well as professional and welcoming in tone

Job Responsibility

Works with faculty and administrative staff in an academic setting to support activities and events related to the graduate and post-graduate level programs of the Marriage and Family Therapy Training Program
Family Therapy Programs’ Recruitment: Review applications in Slate for program suitability and review applicant files with the Director
Send weekly or more frequent updates to the Director during the recruitment period
Extend invitations to appropriate applicants for Interview Days and handle all logistics for their visit
For those unable to attend, arrange for virtual interviews
Prepare a concise grid of the applicants' brief bios
prepare interview schedule
arrange lunch with invitations to current students who would like to answer questions posed by applicants
Masters in Marriage and Family Therapy Student Education: Oversee student registration within UR Student system
Manage working reports and class schedules

Fulltime

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

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

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 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

Rn Med Policy Development/Research Specialist (Um Experience)

Perform medical technology research to support the Medical Director Staff and Me...

Location

United States , Phoenix

Salary:

Not provided

Blue Cross Blue Shield of Arizona

Expiration Date

Until further notice

Requirements

2 year(s) of experience in clinical field of practice, health insurance, or other health care related field (All Levels)
1 year(s) of experience in medical policy and technology research field (Applies to Level 2)
2 year(s) of experience in medical policy and technology research field (Applies to Level 3)
Associate’s Degree in general field of study or Post High School Nursing Diploma or Certification (LPN only) from an approved program (Applies to All Levels)
Active, current, and unrestricted license to practice in the State of Arizona as a health professional, including RN, LPN, LPT, LBSW, LMSW, or LCSW. (Applies to All Levels)
Intermediate PC proficiency
Intermediate Adobe PDF Standard proficiency
Intermediate word processing, spreadsheet and presentation software proficiency (Applies to All Levels)
Maintain confidentiality and privacy
Advanced clinical knowledge

Job Responsibility

Perform medical technology research to support the Medical Director Staff and Medical Policy Panel with decisions to ensure that medical policies are consistent with the standards of accepted medical practice in the community
Perform medical technology research related to coverage guidelines and new technology and provide evaluation and summarization to Medical Director Staff and/or Medical Policy Panel
Perform medical technology research as requested by other areas of BCBSAZ thru the Medical Policy Referral Form
Develop and revise coverage guidelines and criteria as requested by management, Medical Director staff or Medical Policy Panel
Communicate medical policy information in protocol format to all areas of BCBSAZ requiring this information
Participate as a contributing member on the Medical Policy Panel providing medical policy issues for discussion and, as required, on the Clinical Coding Governance Committee (CCGC)
Maintain a thorough knowledge of all BCBSAZ medical coverage guidelines and other policies, such as BCBS Association Medical Policy Reference Manual, MCG care guidelines and/or Change Healthcare InterQual, and eviCore criteria
From the direction of management, Medical Director staff or Medical Policy Panel, facilitate external consultant reviews concerning a coverage guideline or new technology
Communicate medical policy information in protocol format to healthcare providers upon request
With moderate assistance and review by management, perform basic level of code review

Fulltime

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Clinical Studies Coordinator III

Job Description

Job Responsibility

Requirements

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