Clinical Research Associate Specialist 2 Job at MillenniumSoft Inc (Irvine)

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Senior Clinical Research Associate/Clinical Research Associate II - Oncology

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

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
Preferred therapeutic experience in Oncology
Global clinical trial experience preferred
Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Must be fluent in English and in the native language(s) of the country they will work in
Travel (60-80%) within area is required
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

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor 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

What we offer

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

Fulltime

Clinical Research Specialist

The Cardiovascular (CV) Research Program has quickly grown over the past 3 years...

Location

United States , Phoenix

Salary:

24.33 - 36.19 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Associates Other in related field or an equivalent combination of relevant education and/ or job-related experience in lieu of degree and Minimum 2 years related experience, upon hire
Bachelors Other in related field and 3+ years clinical experience, upon hire (preferred)

Job Responsibility

Lead and manage complex clinical research
Collaborate with Principal Investigators to ensure protocol adherence and scientific integrity
Contribute to study design and methodology
Oversee data collection, management, and quality control
Analyze data, prepare detailed reports, and contribute to presentations and publications
Coordinates and schedules subject study visits
Provides study specific, individualized education to study subjects and families
Ensures all appropriate subject consents are obtained
Collects and processes protocol required specimens
Acts as a liaison between Sponsor, Investigator, and Study Subject

What we offer

Medical, prescription drug, dental, vision plans, life insurance, paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually), tuition reimbursement, retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings

Fulltime

Senior Clinical Research Associate

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

Location

Argentina

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 3 years relevant experience in clinical research site monitoring (preferably 2 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

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

Human Subject Research Specialist I

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

Location

United States of America , Rochester

Salary:

21.36 - 29.90 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelors’ Degree Required
Or equivalent combination of education and experience Required
1- 2 years’ experience in clinical research coordination or technology research Preferred
Ability to perform and analyze basic statistical information
Knowledge of Microsoft Word, Excel and Powerpoint
Strong attention to detail and excellent interpersonal and communication skills, including writing ability

Job Responsibility

Plans, coordinates and conducts/implements all research activities associated with the development of patient and caregiver reported outcome measures, longitudinal studies and instrument translations/cultural validations
Interprets research data at the completion of each phase of instrument development and at completion of study milestones creates written summaries with tables and figures for distribution to study sponsors and for presentation at various industry events
Under the direction of the Principal Investigator, assists in the conduct of research studies beginning with the preparation of IRB materials
Coordinates subject recruitment, conducts patient interviews, programs data instrument in REDCap, implements REDCap surveys, monitors data collection within REDCap
Conducts analysis and interpretation of collected data from research studies in anticipation of validating patient and caregiver reported outcome measures
Research grant opportunities and assists with preparation of grant application materials
Assists with the preparation of study proposals for potential collaborators
Prepares grant and study sponsor milestone reports
Presents data to grant-making organizations or study sponsors as requested
Disseminates research findings by drafting abstracts, presentations, and publications for peer review and industry forums

Fulltime

Human Subject Research Specialist I

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

Location

United States of America , Rochester

Salary:

21.36 - 29.90 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelors’ Degree required
Or equivalent combination of education and experience required
1- 2 years’ experience in clinical research coordination or technology research preferred
Ability to perform and analyze basic statistical information
Knowledge of Microsoft Word, Excel and Powerpoint
Strong attention to detail and excellent interpersonal and communication skills, including writing ability

Job Responsibility

Plans, coordinates and conducts/implements all research activities associated with the development of patient and caregiver reported outcome measures, longitudinal studies and instrument translations/cultural validations
Interprets research data at the completion of each phase of instrument development and at completion of study milestones creates written summaries with tables and figures for distribution to study sponsors and for presentation at various industry events
Under the direction of the Principal Investigator, assists in the conduct of research studies beginning with the preparation of IRB materials through the following activities, all within scope of approved protocol: coordinates subject recruitment, conducts patient interviews, programs data instrument in REDCap, implements REDCap surveys, monitors data collection within REDCap
Conducts analysis and interpretation of collected data from research studies in anticipation of validating patient and caregiver reported outcome measures
Researches grant opportunities and assists with preparation of grant application materials
Assists with the preparation of study proposals for potential collaborators
Prepares grant and study sponsor milestone reports
Presents data to grant-making organizations or study sponsors as requested
Disseminates research findings by drafting abstracts, presentations, and publications for peer review and industry forums
Participates in professional associations/organizations dedicated to the neurologic diseases addressed in our research

Fulltime

Clinical Nurse Specialist

Position will include Magnet Program project management as organization prepares...

Location

United States , Sheboygan County

Salary:

51.05 - 76.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Registered Nurse license issued by the state in which the team member practices
Clinical Nurse Specialist (CNS) certification issued by the American Nurses Credentialing Center (ANCC) needs to be obtained within 2 years
Critical Care Registered Nurse (CCRN) certification issued by the American Association of Critical-Care Nurses (AACN) needs to be obtained within 2 years
Advanced Oncology Certified Clinical Nurse Specialist (AOCNS) certification issued by the Oncology Nursing Certification Corporation (ONCC) needs to be obtained within 2 years
Orthopedic Clinical Nurse Specialist - Certified (OCNS-C) certification issued by the Orthopaedic Nurses Certification Board (ONCB) needs to be obtained within 2 years
Nursing certification in one or more specialty-specific areas issued by the American Nurses Credentialing Center (ANCC) or other approved national governing body
Basic Life Support (BLS) for Healthcare Providers certification issued by the American Heart Association (AHA) needs to be obtained within 6 months unless department leader has determined it is not required
Master's Degree in Nursing
Typically requires 2 years of experience in nursing or clinical specialty area
Must also complete 500 clinical hours in a clinical nurse specialist program

Job Responsibility

Advances nursing practice through innovative evidence-based interventions, best practice guidelines, research, and modifications of professional standards and organizational policies that direct the care of nursing staff and other providers to improve outcomes
Provides leadership and expertise in designing, implementing, and evaluating innovative individual and/or population-based programs of care to achieve desired quality, cost-effective, nurse-sensitive outcomes
Provides input, direction and expertise in the assessment/development, implementation and evaluation of orientation, annual competency assessment, and specialty or expertise related continuing education programs
Collaborates with other leadership, and provides consultation and clinical resources to staff, management, administration, and external agencies and organizations related to area of expertise as well as the value of nursing care within the organization
Collaborates with the Manager, staff, healthcare providers and other disciplines to monitor and ensure compliance with local, state, federal, and other regulatory agencies
Establishes and monitors care standards and facilitates change(s) in area of clinical practice. Initiates change for nursing practices and patient plans of care based on data analyses
In collaboration with other healthcare practitioners, contributes to the achievement of service and clinical quality goals
Coaches clinical nurses in the professional development model and mentors patient care managers, coaches, and other professional peer review team members in the process where applicable
Promotes research and evidence-based practice through the review, interpretation, and implementation of research findings. Facilitates development of abstracts, research proposals and conduction of research. Coaches and mentors clinical caregivers to participate in research opportunities. Role models the use of research and evidence based findings
Must be able to demonstrate knowledge and skills necessary to provide care appropriate to the age of the patients served. Must demonstrate knowledge of the principles of growth and development over the life span and possess the ability to assess data reflective of the patient's status and interpret the appropriate information needed to identify each patient's requirements relative to his/her age-specific needs, and to provide the care needed as described in the department's policies and procedures

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 based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance

Fulltime

Clinical Nurse Specialist

Location

United States , Park Ridge

Salary:

51.05 - 76.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Masters of Nursing Degree as APRN-CNS
2 years RN experience preferred
1 year APRN-CNS experience in the relevant setting preferred
Well-developed interpersonal and communication skills
Proficiency with an Electronic Medical Record
National certification as a CNS from an accredited body
Current Illinois APRN License
Current Illinois Registered Nurse license
Current Illinois Controlled Substance License within 6 months of hire
Eligible for DEA registration

Job Responsibility

Completes and documents accurate comprehensive, episodic history and physical assessments
Performs ordering, conducting, supervising, and interpreting diagnostic laboratory and imaging studies
Prescribes treatments, and therapies not limited to medications, diet, supplies, prosthetic devices, and equipment
Implements primary and secondary prevention strategies and management of acute and chronic health problems
Provides clear, concise, accurate, and legible information regarding patient care in the record
Formulates a comprehensive plan of care in collaborating with the patient and interdisciplinary team
Fulfills billing and productivity metrics requirements where appropriate and maintains relevant documentation
Provides other clinical duties as appropriate
Works with interdisciplinary team to develop resource conscious care delivery strategies
Provides education to patients, families, staff and significant others using established education materials and assists patient and families in making healthcare decisions

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 based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance

Fulltime

Clinical Nurse Specialist Cardiac and Heart Failure

Location

United States

Salary:

51.05 - 76.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Masters of Nursing Degree as APRN-CNS or must be currently enrolled
2 years RN experience preferred
1 year APRN-CNS experience in the relevant setting preferred
Well-developed interpersonal and communication skills
Proficiency with an Electronic Medical Record
National certification as a CNS from an accredited body
Current Illinois APRN License
Current Illinois Registered Nurse license
Current Illinois Controlled Substance License within 6 months of hire
Eligible for DEA registration

Job Responsibility

Completes and documents accurate comprehensive, episodic history and physical assessments
Performs ordering, conducting, supervising, and interpreting diagnostic laboratory and imaging studies
Prescribes treatments, and therapies not limited to medications, diet, supplies, prosthetic devices, and equipment
Implements primary and secondary prevention strategies and management of acute and chronic health problems
Provides clear, concise, accurate, and legible information regarding patient care in the record
Formulates a comprehensive plan of care in collaborating with the patient and interdisciplinary team
Fulfills billing and productivity metrics requirements where appropriate and maintains relevant documentation
Provides other clinical duties as appropriate
Works with interdisciplinary team to develop resource conscious care delivery strategies
Provides education to patients, families, staff and significant others using established education materials and assists patient and families in making healthcare decisions

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

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Clinical Research Associate Specialist 2

Job Description

Job Responsibility

Requirements

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