Oncology Research Coordinator, Levine Cancer Center

American Addiction Centers • Charlotte, NC

4d • $29 - $43 • Onsite

About The Position

Coordinates the clinical, regulatory, business, and other research- related activities and documentation for observational studies 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.

Requirements

• Bachelor's Degree and 3 years of clinical research experience (Oncology research experience preferred) or equivalent experience required; or Master's Degree and 2 years of clinical research experience (Oncology research experience preferred) or equivalent experience required.
• Health/Science degree preferred.
• Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research.
• Must speak and read/write clearly in English.

Nice To Haves

• Oncology research experience preferred
• Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research.

Responsibilities

• Assesses patient eligibility through chart reviews.
• Collaborates with regulatory team, Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO/monitor, and other internal/external customers; coordinates documentation/submissions.
• 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).
• 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.
• Review patient Charts and perform data entry into REDCap database.
• Track patient enrollment in REDCap database (update boards).
• Regularly meet with investigators for quality reviews to ensure data entry is correct.
• Perform periodic data review meetings– create and present reports, discuss and resolve any issues that may arise during data review meetings.
• Is knowledgeable in the disease characteristics, treatments, and outcome measures relevant for your disease site.
• Actively engage the investigators on a regular (preferably weekly or biweekly) basis regarding database.
• Work closely with statisticians and systems engineer regarding needed changes or upcoming projects.
• Be responsive to all requests for data clarification or new data acquisition needs.
• Interacts with all teammates, investigators, and clients in a professional and courteous manner.
• Works closely with investigators, fellows, students, and statisticians regarding data needs, study timelines, and submission deadlines.
• Keeps all stakeholders on track for successful project completion.
• Reminds investigators of upcoming conference or other deadlines and proactively start process for project initiation.
• Assists in completion, maintenance, and distribution of Project Organizer for all new projects.
• Shows initiative for following study from inception to manuscript or other final data disclosure.
• Maintains an active SharePoint and/or Microsoft Teams site for project management.
• Is a proven subject matter expert in the disease site regarding data collected for research.
• Participates in continued learning opportunities through online or in-person classes.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level