Clinical Research Project Coordinator II or Senior - Intermountain Health
Atlanta, GA
About the Job
Job Description:
The Clinical Research Project Coordinator II (Phase I & CAR-T) Or Senior level coordinator role plays a pivotal role in supporting research projects across various departments, ensuring timely activation and successful completion of research initiatives. The Clinical Research Project Coordinator II is responsible for managing routine to moderately complex projects across multiple departments, providing expert coordination and project management. This role involves meticulous communication and documentation to meet the specific needs of research departments.
NOTE: We will hire at Coordinator II or Senior level - see minimum requirement details & starting salary rates below.
Essential Functions
+ Advanced Research Support: Provide expert support for various complex clinical research studies and departments across the Intermountain system, ensuring high-quality execution and compliance.
+ Project Planning & Execution: Define, develop, and execute sophisticated clinical research project plans, including detailed work plans and schedules, and resource allocation. Manage more complex project plans and identify needed resources, roles, and responsibilities for assigned studies. Facilitate feedback from key participants and lead project teams as needed.
+ Budget & Scope Management: Develop and manage comprehensive budget and scope documents for clinical research studies. Track expenses, forecast financial needs, and assist with business case and proposal development. Create and oversee budgets, track expenses, and forecast financial needs for the clinical research project. Utilize advanced project management tools to monitor budget, plans, and expenses.
+ Compliance & Quality Assurance: Ensure compliance with study requirements, sponsor guidelines, and regulatory standards. Lead quality assurance initiatives, document deliverables, and prepare comprehensive reports and presentations. Communicate impacts on existing studies to internal and external stakeholders. Implement cost-effective methods to facilitate study execution while meeting functional and regulatory requirements. Support research billing by reviewing research accounts and reconciling invoices.
+ Study Lifecycle Management: Oversee study startup, maintenance, and closeout activities. Provide expert backup and support as a Clinical Research Coordinator (CRC) and act as a source expert and liaison.
+ Medicare Coverage Analysis: Lead the development and review of Medicare Coverage Analysis for clinical trials, ensuring correct billing and compliance with reimbursement guidelines.
+ Training & Mentorship: Train and mentor research staff on regulatory requirements, procedures, and best practices. Develop and update Standard Operating Procedures (SOPs) and provide advanced education on federal policies and regulations.
+ Communication & Stakeholder Liaison: Communicate effectively with high-level stakeholders, including PIs, sponsors, regulatory authorities, study sites, regulatory bodies, researchers, study teams, IRBs, sponsors, CROs, and other third parties to obtain necessary approvals and documentation. Act as a senior liaison between the research team and regulatory bodies. Professionally manage research relationships with collaborating institutions, investigators, sponsors, and monitors.
Skills
+ Budget Monitoring
+ Organization
+ Verbal and Written Communication
+ Teamwork
+ Financial Negotiation
+ Mult-tasking
+ Prioritization
+ Process Improvement
+ Critical Thinking
+ Technical Proficiency
Minimum Qualifications (Coordinator II - starting $29.66/hr)
+ Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills; Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.
+ Demonstrated experience working in a collaborative team environment.
+ Experience using word processing, spreadsheet, database, internet, e-mail, and scheduling applications.
+ Ability to travel within the Intermountain system and work from different locations as assigned. Occasional overnight travel may be required.
+ Clinical licensure, experience or certification may be required due to grant funding requirements.
+ Three (3) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures.
Minimum Qualifications (Senior level - starting at $36.22/hr)
+ Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills; Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.
+ Demonstrated experience working in a collaborative team environment.
+ Experience using word processing, spreadsheet, database, internet and e-mail and scheduling applications.
+ Ability to travel within the Intermountain system and work from different locations as assigned. Occasional overnight travel may be required.
Preferred Qualifications
+ Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A degree must be obtained through an accredited institution. Education is verified.
+ Four (4) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures.
+ Basic knowledge and ability to interpret Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs).
+ Experience in clinical research setting, including relevant study management experience.
+ Experience in a healthcare or hospital setting.
Physical Requirements:
Physical Requirements
+ Ongoing need for employee to see and read information, labels, monitors, etc. and to see to identify equipment and supplies and to utilize a wide variety of information including organizing and completing documentation and forms, accessing and entering computer information, and identifying needs and urgent issues.
+ Frequent interactions with providers, colleagues, customers, patients/clients, and visitors that require employee to verbally communicate as well as hear and understand spoken information, needs, and issues quickly and accurately.
+ Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy. This includes frequent computer use and typing for documenting patient interactions, accessing needed information, operating telephones and other office equipment, including manipulating paper - requiring the ability to move fingers and hands.
+ Expected to bend, lift, and carry patient files, documents, equipment, and supplies.
+ Remain sitting or standing for long periods of time while interacting with others or to perform work on a computer, telephone, or other equipment.
+ For roles requiring driving: Expected to drive a vehicle which requires sitting, seeing and reading signs, traffic signals, and other vehicles.
Location:
LDS Hospital
Work City:
Salt Lake City
Work State:
Utah
Scheduled Weekly Hours:
40
The hourly range for this position is listed below. Actual hourly rate dependent upon experience.
$29.66 - $46.72
We care about your well-being – mind, body, and spirit – which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged.
Learn more about our comprehensive benefits packages for our Idaho, Nevada, and Utah based caregivers (https://intermountainhealthcare.org/careers/working-for-intermountain/employee-benefits/) , and for our Colorado, Montana, and Kansas based caregivers (http://www.sclhealthbenefits.org) ; and our commitment to diversity, equity, and inclusion (https://intermountainhealthcare.org/careers/working-for-intermountain/diversity/) .
Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
All positions subject to close without notice.
The Clinical Research Project Coordinator II (Phase I & CAR-T) Or Senior level coordinator role plays a pivotal role in supporting research projects across various departments, ensuring timely activation and successful completion of research initiatives. The Clinical Research Project Coordinator II is responsible for managing routine to moderately complex projects across multiple departments, providing expert coordination and project management. This role involves meticulous communication and documentation to meet the specific needs of research departments.
NOTE: We will hire at Coordinator II or Senior level - see minimum requirement details & starting salary rates below.
Essential Functions
+ Advanced Research Support: Provide expert support for various complex clinical research studies and departments across the Intermountain system, ensuring high-quality execution and compliance.
+ Project Planning & Execution: Define, develop, and execute sophisticated clinical research project plans, including detailed work plans and schedules, and resource allocation. Manage more complex project plans and identify needed resources, roles, and responsibilities for assigned studies. Facilitate feedback from key participants and lead project teams as needed.
+ Budget & Scope Management: Develop and manage comprehensive budget and scope documents for clinical research studies. Track expenses, forecast financial needs, and assist with business case and proposal development. Create and oversee budgets, track expenses, and forecast financial needs for the clinical research project. Utilize advanced project management tools to monitor budget, plans, and expenses.
+ Compliance & Quality Assurance: Ensure compliance with study requirements, sponsor guidelines, and regulatory standards. Lead quality assurance initiatives, document deliverables, and prepare comprehensive reports and presentations. Communicate impacts on existing studies to internal and external stakeholders. Implement cost-effective methods to facilitate study execution while meeting functional and regulatory requirements. Support research billing by reviewing research accounts and reconciling invoices.
+ Study Lifecycle Management: Oversee study startup, maintenance, and closeout activities. Provide expert backup and support as a Clinical Research Coordinator (CRC) and act as a source expert and liaison.
+ Medicare Coverage Analysis: Lead the development and review of Medicare Coverage Analysis for clinical trials, ensuring correct billing and compliance with reimbursement guidelines.
+ Training & Mentorship: Train and mentor research staff on regulatory requirements, procedures, and best practices. Develop and update Standard Operating Procedures (SOPs) and provide advanced education on federal policies and regulations.
+ Communication & Stakeholder Liaison: Communicate effectively with high-level stakeholders, including PIs, sponsors, regulatory authorities, study sites, regulatory bodies, researchers, study teams, IRBs, sponsors, CROs, and other third parties to obtain necessary approvals and documentation. Act as a senior liaison between the research team and regulatory bodies. Professionally manage research relationships with collaborating institutions, investigators, sponsors, and monitors.
Skills
+ Budget Monitoring
+ Organization
+ Verbal and Written Communication
+ Teamwork
+ Financial Negotiation
+ Mult-tasking
+ Prioritization
+ Process Improvement
+ Critical Thinking
+ Technical Proficiency
Minimum Qualifications (Coordinator II - starting $29.66/hr)
+ Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills; Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.
+ Demonstrated experience working in a collaborative team environment.
+ Experience using word processing, spreadsheet, database, internet, e-mail, and scheduling applications.
+ Ability to travel within the Intermountain system and work from different locations as assigned. Occasional overnight travel may be required.
+ Clinical licensure, experience or certification may be required due to grant funding requirements.
+ Three (3) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures.
Minimum Qualifications (Senior level - starting at $36.22/hr)
+ Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills; Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.
+ Demonstrated experience working in a collaborative team environment.
+ Experience using word processing, spreadsheet, database, internet and e-mail and scheduling applications.
+ Ability to travel within the Intermountain system and work from different locations as assigned. Occasional overnight travel may be required.
Preferred Qualifications
+ Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A degree must be obtained through an accredited institution. Education is verified.
+ Four (4) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures.
+ Basic knowledge and ability to interpret Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs).
+ Experience in clinical research setting, including relevant study management experience.
+ Experience in a healthcare or hospital setting.
Physical Requirements:
Physical Requirements
+ Ongoing need for employee to see and read information, labels, monitors, etc. and to see to identify equipment and supplies and to utilize a wide variety of information including organizing and completing documentation and forms, accessing and entering computer information, and identifying needs and urgent issues.
+ Frequent interactions with providers, colleagues, customers, patients/clients, and visitors that require employee to verbally communicate as well as hear and understand spoken information, needs, and issues quickly and accurately.
+ Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy. This includes frequent computer use and typing for documenting patient interactions, accessing needed information, operating telephones and other office equipment, including manipulating paper - requiring the ability to move fingers and hands.
+ Expected to bend, lift, and carry patient files, documents, equipment, and supplies.
+ Remain sitting or standing for long periods of time while interacting with others or to perform work on a computer, telephone, or other equipment.
+ For roles requiring driving: Expected to drive a vehicle which requires sitting, seeing and reading signs, traffic signals, and other vehicles.
Location:
LDS Hospital
Work City:
Salt Lake City
Work State:
Utah
Scheduled Weekly Hours:
40
The hourly range for this position is listed below. Actual hourly rate dependent upon experience.
$29.66 - $46.72
We care about your well-being – mind, body, and spirit – which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged.
Learn more about our comprehensive benefits packages for our Idaho, Nevada, and Utah based caregivers (https://intermountainhealthcare.org/careers/working-for-intermountain/employee-benefits/) , and for our Colorado, Montana, and Kansas based caregivers (http://www.sclhealthbenefits.org) ; and our commitment to diversity, equity, and inclusion (https://intermountainhealthcare.org/careers/working-for-intermountain/diversity/) .
Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
All positions subject to close without notice.
Source : Intermountain Health