Senior Clinical Research Specialist Job at Imricor Medical Systems (Burnsville)

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

Senior Contract Specialist, Clinical Research Agreement

The Clinical Research Agreements team manages the contract negotiation of indust...

Location

United States , Boston

Salary:

69888.00 - 111831.20 USD / Year

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

Bachelor's degree
2+ years of relevant experience
ability to effectively negotiate with peer level department heads and/or with external agencies/facilities on issues and programs that impact department as well as several other large departments/divisions

Job Responsibility

Drafts and negotiates written clinical research related agreements with corporate sponsors and other outside entities
Conducts negotiation of complex clinical research agreements and attends to relevant terms
Assures timely completion of negotiation proceedings
Acquires and maintains knowledge of Hospital’s policies and procedures applicable to clinical sponsored research
Develops functional understanding of the business needs of the hospital administrative and research staff
Evaluates and makes recommendations for systems, policies and procedures
Advises faculty on BCH and sponsor requirements for clinical corporate sponsored research agreements
Responsible for overseeing pre award administration of clinical research agreements
Supports strategies for marketing the hospital’s research capabilities and clinical trial resources to industry
Advises on quality improvement efforts

What we offer

flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement
cell phone plan discounts
discounted rates on T-passes

Fulltime

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

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

Senior Clinical Trial Specialist

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

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree or certification in a relevant field such as life sciences, healthcare, or clinical research
Extensive experience in a clinical trial support role, with a solid understanding of clinical trial processes and regulatory requirements
Strong organizational and multitasking skills, with the ability to manage multiple tasks and projects effectively
Proficiency in clinical trial management systems and relevant software, with a keen eye for detail in documentation and data management
Excellent communication, interpersonal, and problem-solving skills, with the ability to work collaboratively with diverse teams and stakeholders

Job Responsibility

Providing administrative support for clinical trials, including managing documentation, coordinating meetings, and maintaining trial-related records
Assisting in the preparation and submission of regulatory documents and ensuring compliance with study protocols and regulatory requirements
Collaborating with cross-functional teams to support trial operations and resolve any issues that arise during the course of the study
Monitoring and tracking trial progress, including managing site communications and ensuring timely delivery of study materials
Building and maintaining strong relationships with site staff and other stakeholders to facilitate smooth trial operations and support overall project success

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

Senior Clinical Trial Specialist

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

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree or certification in a relevant field such as life sciences, healthcare, or clinical research
Extensive experience in a clinical trial support role, with a solid understanding of clinical trial processes and regulatory requirements
Strong organizational and multitasking skills, with the ability to manage multiple tasks and projects effectively
Proficiency in clinical trial management systems and relevant software, with a keen eye for detail in documentation and data management
Excellent communication, interpersonal, and problem-solving skills, with the ability to work collaboratively with diverse teams and stakeholders

Job Responsibility

Providing administrative support for clinical trials, including managing documentation, coordinating meetings, and maintaining trial-related records
Assisting in the preparation and submission of regulatory documents and ensuring compliance with study protocols and regulatory requirements
Collaborating with cross-functional teams to support trial operations and resolve any issues that arise during the course of the study
Monitoring and tracking trial progress, including managing site communications and ensuring timely delivery of study materials
Building and maintaining strong relationships with site staff and other stakeholders to facilitate smooth trial operations and support overall project success

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

Environmental Research Safety Specialist, Senior

Manage and oversee portions of the Accreditation Environment of Care (TJC), and/...

Location

United States , Charlotte; Winston Salem

Salary:

44.15 - 66.25 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Bachelor’s Degree Environmental Health and Safety
Minimum 5 years of experience in related discipline required (safety and/or facilities management that includes experience in emergency management, environmental safety, and life safety)
Must have the ability to clearly communicate verbally, in person, and in writing with patients, families/agencies and the health care team
Must possess a sense of urgency and make sound decisions
Responsible for setting a strong example of safety by working safely and utilizing personal protective equipment (PPE) appropriately
Critical thinking and independent decision making and is solution oriented
Ability to operate computer and computer software programs
This position requires travel, therefore, will be exposed to weather and road conditions
Travel to other facilities in a personal vehicle is required
Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders, and twist frequently throughout the workday

Job Responsibility

Manage and oversee portions of the Accreditation Environment of Care (TJC), and/or Physical Environment (DNV) Safety programs for multiple Advocate facilities
Act as liaison for all chapters (Safety, Security, Hazardous Materials/Waste, Clinical Engineering, Fire Safety and Utilities) within the program
Coordinate and chair the Environment of Care or Physical Environment Committee, maintain committee agendas and minutes, communicate safety updates to committee
Assists with, Occupational Health and Safety (OSHA), Environmental Compliance (EPA), Construction Safety, and Operations activities to maintain constant readiness for surveys and inspections
serves as a safety point of contact during federal, state, local and organizational surveys, and inspections
Supports regulatory agency personnel during compliance inspections
Interfaces with Advocate Facility Administration and Department Leadership to oversee special projects as directed by Safety Leadership and Facility Administration
Presents safety programs, safety updates, and/or training to leadership, physicians, vendors/contractors, and teammates
Discuss safety and risk assessment impacts to operational changes that has effect on patient safety, teammate safety, visitor safety, and life safety
Initiate and disseminate PCRA (Pre-Construction Risk Assessment), ICRA (Infection Control Risk Assessment) and ILSM (Interim Life Safety Measures) documentation for projects at multiple facilities

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

Environmental Research Safety Specialist, Senior

Manage and oversee portions of the Accreditation Environment of Care (TJC), and/...

Location

United States , Charlotte; Winston Salem

Salary:

44.15 - 66.25 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Bachelor’s Degree Environmental Health and Safety
Minimum 5 years of experience in related discipline required (safety and/or facilities management that includes experience in emergency management, environmental safety, and life safety)
Must have the ability to clearly communicate verbally, in person, and in writing with patients, families/agencies and the health care team
Must possess a sense of urgency and make sound decisions
Responsible for setting a strong example of safety by working safely and utilizing personal protective equipment (PPE) appropriately
Critical thinking and independent decision making and is solution oriented
Ability to operate computer and computer software programs
This position requires travel, therefore, will be exposed to weather and road conditions
Travel to other facilities in a personal vehicle is required
Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders, and twist frequently throughout the workday

Job Responsibility

Manage and oversee portions of the Accreditation Environment of Care (TJC), and/or Physical Environment (DNV) Safety programs for multiple Advocate facilities
Act as liaison for all chapters (Safety, Security, Hazardous Materials/Waste, Clinical Engineering, Fire Safety and Utilities) within the program
Coordinate and chair the Environment of Care or Physical Environment Committee, maintain committee agendas and minutes, communicate safety updates to committee
Assists with, Occupational Health and Safety (OSHA), Environmental Compliance (EPA), Construction Safety, and Operations activities to maintain constant readiness for surveys and inspections
serves as a safety point of contact during federal, state, local and organizational surveys, and inspections
Supports regulatory agency personnel during compliance inspections
Interfaces with Advocate Facility Administration and Department Leadership to oversee special projects as directed by Safety Leadership and Facility Administration
Presents safety programs, safety updates, and/or training to leadership, physicians, vendors/contractors, and teammates
Discuss safety and risk assessment impacts to operational changes that has effect on patient safety, teammate safety, visitor safety, and life safety
Initiate and disseminate PCRA (Pre-Construction Risk Assessment), ICRA (Infection Control Risk Assessment) and ILSM (Interim Life Safety Measures) documentation for projects at multiple facilities

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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Senior Clinical Research Specialist

Job Description

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Requirements

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