Atrium Health
Oncology Research Coordinator - Study Start Up (SSU) Atrium Health
Atrium Health, Charlotte, North Carolina, United States, 28245
Job Information
Department:
80096 Carolinas Medical Center - LC: Clinical Trials: Morehead
Status:
Full time
Benefits Eligible:
Yes
Hours Per Week:
40
Schedule Details/Additional Information:
This role will support the CTMS (OnCore) calendar build process to ensure calendar builds are properly aligned with protocol requirements.
Other Skills
Able to manage multiple tasks producing high quality work
Able to work across multiple teams within the Clinical Trials Office and other interdisciplinary teams
Self-starter and results driven
Strong attention to details
Strong organizational skills
Good communication skills
Proficiency with standard computer software applications (i.e., MS Word, Excel, PowerPoint, Outlook, internet navigation), ability to quickly learn project-specific computer applications as required
Remote / hybrid, M-F (8am - 5pm)
Pay Range $28.05 - $42.10
Essential Functions
Fulfills the job responsibilities of the Oncology Research Specialist, and:
Coordinates clinical and regulatory document submissions for clinical trial start-up, consent development and amendment, protocol amendment, continuing review, closure to accrual, action letter, suspension, termination and other reportable regulatory information.
Assesses patient eligibility through chart reviews and patient/family interviews.
Assists in providing patient education regarding the nature of their disease and the benefits/risks of participating in a clinical drug trial.
Collaborates with regulatory team, Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO/monitor and other internal/external customers; coordinates documentation/submissions. Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required.
Presents and obtains patient informed consent.
Coordinates accurate data collection and record keeping by reviewing documents and processes for quality assurance and ensures timely and accurate submission of data.
Coordinates and prepares for internal and external audits.
Participates in sponsor study start-up and follow-up meetings as appropriate.
Develops study calendars.
Collaborates on billing and financial activity with Research Finance (budgets and billing compliance).
Coordinates scheduling of patient visits, labs, and diagnostic procedures.
Coordinates drug shipments, storage, and accountability with IDS/Pharmacy.
Assists in the development, improvement and review of Standard Operating Procedures and processes.
Provides educational and technical assistance to research staff including orientation and mentoring of new research teammates.
Physical Requirements Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in LCI clinical trials.
Education, Experience and Certifications Bachelor's Degree and 1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master's Degree and 0-1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 3 years clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required with no degree. Health/Science degree preferred. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.
Our Commitment to You Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:
Compensation
Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
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
Benefits and More
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
About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.
Additional Clinical Trials Coordination Coordinates the clinical, regulatory, business, and other research‑related activities and documentation for clinical trials conducted, follows industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH.
#J-18808-Ljbffr
80096 Carolinas Medical Center - LC: Clinical Trials: Morehead
Status:
Full time
Benefits Eligible:
Yes
Hours Per Week:
40
Schedule Details/Additional Information:
This role will support the CTMS (OnCore) calendar build process to ensure calendar builds are properly aligned with protocol requirements.
Other Skills
Able to manage multiple tasks producing high quality work
Able to work across multiple teams within the Clinical Trials Office and other interdisciplinary teams
Self-starter and results driven
Strong attention to details
Strong organizational skills
Good communication skills
Proficiency with standard computer software applications (i.e., MS Word, Excel, PowerPoint, Outlook, internet navigation), ability to quickly learn project-specific computer applications as required
Remote / hybrid, M-F (8am - 5pm)
Pay Range $28.05 - $42.10
Essential Functions
Fulfills the job responsibilities of the Oncology Research Specialist, and:
Coordinates clinical and regulatory document submissions for clinical trial start-up, consent development and amendment, protocol amendment, continuing review, closure to accrual, action letter, suspension, termination and other reportable regulatory information.
Assesses patient eligibility through chart reviews and patient/family interviews.
Assists in providing patient education regarding the nature of their disease and the benefits/risks of participating in a clinical drug trial.
Collaborates with regulatory team, Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO/monitor and other internal/external customers; coordinates documentation/submissions. Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required.
Presents and obtains patient informed consent.
Coordinates accurate data collection and record keeping by reviewing documents and processes for quality assurance and ensures timely and accurate submission of data.
Coordinates and prepares for internal and external audits.
Participates in sponsor study start-up and follow-up meetings as appropriate.
Develops study calendars.
Collaborates on billing and financial activity with Research Finance (budgets and billing compliance).
Coordinates scheduling of patient visits, labs, and diagnostic procedures.
Coordinates drug shipments, storage, and accountability with IDS/Pharmacy.
Assists in the development, improvement and review of Standard Operating Procedures and processes.
Provides educational and technical assistance to research staff including orientation and mentoring of new research teammates.
Physical Requirements Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in LCI clinical trials.
Education, Experience and Certifications Bachelor's Degree and 1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master's Degree and 0-1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 3 years clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required with no degree. Health/Science degree preferred. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.
Our Commitment to You Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:
Compensation
Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
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
Benefits and More
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
About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.
Additional Clinical Trials Coordination Coordinates the clinical, regulatory, business, and other research‑related activities and documentation for clinical trials conducted, follows industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH.
#J-18808-Ljbffr