Oncology Research Coordinator, Levine Cancer Center

United States·Charlottemid

OtherResearch Coordinator

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Quick Summary

Key Responsibilities

Coordinates clinical and regulatory document submissions for clinical trial start-up, consent development and amendment, protocol amendment, continuing review, closure to accrual, action letter,

Requirements Summary

Advocate

Technical Tools

OtherResearch Coordinator

Department:

37294 Carolinas Medical Center - LC: Biostatistics and Data Sciences: Morehead

Status:

Full time

Benefits Eligible:

Yes

Hours Per Week:

Schedule Details/Additional Information:

8 AM-5PM Weekdays (Monday-Friday)

$28.55 - $42.85

Job Summary

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. This position is responsible for developing and managing the Myeloma Oncology REDCap database for Levine Cancer Institute. This database provides prospective and retrospective data on Myeloma oncology patients seen at LCI. The data is used for clinical and research projects which generate conference presentations, manuscripts, and grant proposals.

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.

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.

Requirements

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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:

What We Offer

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✓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

✓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

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.