Site Care Partner Job at Parexel

Senior Clinical Research Associate - Midwest/Central US - FSP

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)
Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
Must be fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver's license and passport required

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's 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
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
Monitor site level adverse events (AEs) and serious adverse events (SAEs)
Submit all required reports, documentation, updates and tracking within required timeframes
Identify and resolve investigator site issues within required timeframes
Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines

Fulltime

New

Clinical Research Associate II/Senior Clinical Research Associate

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)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Must be fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock
Serve as the primary point of contact for assigned investigator sites
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel
Attend investigator meeting when required
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit
Submit all required reports, documentation, updates and tracking within required timeframes
Identify and resolve investigator site issues within required timeframes

What we offer

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

Senior Clinical Research Associate

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

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
Must be fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's 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
Serve as the primary point of contact for assigned investigator sites during study conduct
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel
Provide protocol training to, and address protocol related questions from the investigator site staff
Attend investigator meeting when required (virtual or F2F)
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
Monitor site level adverse events (AEs) and serious adverse events (SAEs)
Submit all required reports, documentation, updates and tracking within required timeframes

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

Fulltime

Senior Clinical Research Associate

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

Location

Canada , Remote

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
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
Must be fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's 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
Serve as the primary point of contact for assigned investigator sites during study conduct
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel
Provide protocol training to, and address protocol related questions from the investigator site staff
Attend investigator meeting when required (virtual or F2F)
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
Monitor site level adverse events (AEs) and serious adverse events (SAEs)
Submit all required reports, documentation, updates and tracking within required timeframes

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

Fulltime

Clinical Research Associate II/Sr. Clinical Research Associate - 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

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
Must be fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's 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
Serve as the primary point of contact for assigned investigator sites
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with Site Care Partner 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
Attend investigator meeting when required (virtual or F2F)
Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
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

What we offer

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

Site Care Partner Lead CRA

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

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Good computer skills and ability to embrace new technologies
Good communication, presentation, and interpersonal skills
Ability to manage required travel
Demonstrated networking and relationship building skills
Demonstrated ability to manage cross functional relationships
Ability to communicate effectively with internal & external stakeholders
Ability to adapt to changing technologies and processes
Knowledge of country requirements for GCP
Effectively overcoming barriers during implementation of new processes and systems

Job Responsibility

Site start-up and activation
Deploys client site strategies by qualifying and activating assigned sites
Supports processes to optimize country & site selection activities
Collaborates with key stakeholders providing country/regional level input to country outreach surveys
Maintains a knowledge of assigned protocols
Conducts study start-up activities at the site level
Ensures all the site initiation activity including training per site activation checklist
Supports country specific ICF review and deployment up to Site Activation
Ensures follow up activities’ completion post Site qualification visit and SIV
Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness

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

Fulltime

Patient Access Liaison

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Denver; Phoenix; Salt Lake City

Salary:

178336.00 - 201298.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of patient services, and/or access and reimbursement, experience
Master's degree and 4 years of patient services, and/or access and reimbursement, experience
Bachelor's degree and 6 years of patient services, and/or access and reimbursement, experience
Scientific background and ability to learn product and disease information
Nursing or other clinical background a plus
Access and reimbursement for buy and bill products
Orphan or Rare disease experience
Familiarity with HIPAA guidelines and FDA requirements
Familiarity with and Adherence to internal and OIG Compliance guidelines a must
Ability to handle difficult patient cases and resolve hurdles

Job Responsibility

Provide logistical, non-medical educational assistance to patients and caregivers as well as office and site of care staff, including physicians, nurses, office managers and executives
Work in highly visible, strong team environment to provide exceptional customer service on all levels
Work with the patient, the physician and the Site of Care to educate on next steps required to gain access to therapy
Work to maintain relationships with patients and families, and by extension physicians and their staff and cross-functional partners to support ongoing compliance with therapy
Work with numerous internal teams, including Market Access, Medical Affairs, Advocacy, Marketing, and Site of Care to facilitate and improve patient access to insurance, medications, financial support, resources and more
Secure written or electronic patient HIPAA for patients in the assigned geography
Develop relationships with patients and caregivers by engaging via phone, text, email, virtual or in person connections
Assess individual needs of the patient and develop an appropriate education and resource plan of action, considering the patient’s family and team of healthcare providers to empower the patient to become their own advocate
Educate the patient on UPLIZNA coverage based on their benefits and the steps needed to gain prior authorization to ensure understanding of the process for medication access
Provide information on co-pay assistance programs, national foundations, and free drug programs by sharing information to patients as appropriate and needed

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Patient Access Liaison

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Baltimore

Salary:

178336.00 - 201298.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of patient services, and/or access and reimbursement, experience
Master's degree and 4 years of patient services, and/or access and reimbursement, experience
Bachelor's degree and 6 years of patient services, and/or access and reimbursement, experience
Scientific background and ability to learn product and disease information
Nursing or other clinical background a plus
Access and reimbursement for buy and bill products
Orphan or Rare disease experience
Familiarity with HIPAA guidelines and FDA requirements
Familiarity with and Adherence to internal and OIG Compliance guidelines a must
Ability to handle difficult patient cases and resolve hurdles

Job Responsibility

Provide logistical, non-medical educational assistance to patients and caregivers as well as office and site of care staff
Provide exceptional customer service on all levels
Work with the patient, the physician and the Site of Care to educate on next steps required to gain access to therapy
Work to maintain relationships with patients and families, and by extension physicians and their staff and cross-functional partners to support ongoing compliance with therapy
Work with numerous internal teams to facilitate and improve patient access to insurance, medications, financial support, resources and more
Secure written or electronic patient HIPAA for patients in the assigned geography
Develop relationships with patients and caregivers by engaging via phone, text, email, virtual or in person connections
Assess individual needs of the patient and develop an appropriate education and resource plan of action
Educate the patient on UPLIZNA coverage based on their benefits and the steps needed to gain prior authorization
Provide information on co-pay assistance programs, national foundations, and free drug programs

What we offer

Total Rewards Plan comprising health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives

Fulltime

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