Overview:
Rocky Mountain Cancer Centers, Colorado’s largest and most comprehensive provider of cancer care has an exciting opportunity for a Trial Eligibility Specialist supporting the Research Department at our Midtown locaton in Denver, Colorado
We realize that it sounds cliché but it is true - taking care of cancer patients is a calling. It’s much more than a job. Each of us has a unique story that brought us to Rocky Mountain Cancer Centers (RMCC), but those stories usually share common themes of care, compassion, and commitment.
No matter the role each RMCC team member serves in, the goal is the same: to provide the best care possible for each and every one of our patients. Whether we are a nurse holding our patient’s hand, or a scheduler on the phone finding an appointment that fits into a patient’s schedule, we are deeply connected to our patients and do what we can to help.
If this sounds like you, we’d love to have you join our team.
Under general supervision, provides professional nursing care for patients adhering to national and company standards and guidelines for specialty regulations. Demonstrates knowledge of physiological, psychological, and developmental and age specific differences in the patient population including late adolescence, adulthood, middle age, and the elderly. Collaborates with the interdisciplinary team to provide for assessment and therapeutic management of patient/family needs. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.
Salary Range: $36.00-46.00
Pay is based on several factors including but not limited to education, work experience, certification, etc. As of the date of this posting, in addition to your salary, RMCC offer the following benefits for this position, subject to eligibility requirements: Health, dental, and vision plans; wellness program; health savings account; flexible spending accounts; 401(k) retirement plan; life insurance, short-term disability insurance; long-term disability insurance, Employee Assistance Program; PTO, holiday pay, tuition reimbursement, and employee paid critical illness and accident insurance.
Nurses with OCN certification are eligible for OCN Incentive Pay after 90 days of employment or upon obtainment of certification.

Responsibilities:

• Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials. Responsible for review of consents to ensure proper execution of the informed consent process for study subjects.
• Coordinates patient care in compliance with protocol requirements. Disburses investigational drug and provide patient teaching regarding administration and other patient educational needs. Maintains investigational drug accountability. Oversees the preparation of orders by physicians to assure that protocol compliance is maintained.
• Working independently, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents and reports all findings to physician and care team. Enters orders to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting Provide clinical services as required including patient assessments.
• Responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel. Responsible for compiling and reporting protocol activity, accrual data, and research financials to practice administration and physicians. May be responsible for the development of practice research budgets.
• Maintains regulatory documents in accordance with USOR SOP and applicable regulations. Participate in scheduling monitoring and auditing visits. Interacts with the monitors/auditors while onsite. Provide input in determining, and implementing improvements to policies/processes. Works with clinic staff to solve complex issues around patient trial participation. Develops SOPs in collaboration with research and clinical teams.

• Due to expertise in subject matter, functions in a lead role as a resource for research staff. Conduct protocol-specific training for study personnel to include training of staff in preparation for study activities Review protocols and provide input on study activities in relation to areas of responsibility. May work with SRL to determine study recruitment and enrollment goals. Oversees subject recruitment and study enrollment to meet goals. Leads efforts to find effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials Assists SRL in feasibility assessments and study selection.

  Trial Eligibility Review Specialist Job Responsibilities:

• Responsible for the review of all patient records and study assessments to determine eligibility for clinical trial participation

• Works closely with RMCC providers and clinical staff to ensure required records and documents are present in the EMR and other study-specific systems
• Maintains access to hospital records systems and all sponsor systems required to review records and assessments required for eligibility
• Provides ongoing reporting to management on trends or eligibility concerns identified in during regular participant reviews
• Provides review of previous study enrollments to support audit readiness in an ongoing manner.
• Works with management team on ongoing projects to support audit readiness, ongoing education of team members, development of appropriate SOP’s and work instructions to support same.

Qualifications:

MINIMUM JOB QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES):

Education/Training –
Graduate from an accredited program for professional nursing education, BSN preferred.
RN state license and current registration with the State Board of Nursing in practicing state.
Must maintain continuing education requirements.

BUSINESS EXPERIENCE –

3-5 years nursing experience in research preferred.

SPECIALIZED KNOWLEDGE/SKILLS –

Oncology and research experience preferred.

Responsibilities:

• Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials. Responsible for review of consents to ensure proper execution of the informed consent process for study subjects.
• Coordinates patient care in compliance with protocol requirements. Disburses investigational drug and provide patient teaching regarding administration and other patient educational needs. Maintains investigational drug accountability. Oversees the preparation of orders by physicians to assure that protocol compliance is maintained.
• Working independently, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents and reports all findings to physician and care team. Enters orders to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting Provide clinical services as required including patient assessments.
• Responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel. Responsible for compiling and reporting protocol activity, accrual data, and research financials to practice administration and physicians. May be responsible for the development of practice research budgets.
• Maintains regulatory documents in accordance with USOR SOP and applicable regulations. Participate in scheduling monitoring and auditing visits. Interacts with the monitors/auditors while onsite. Provide input in determining, and implementing improvements to policies/processes. Works with clinic staff to solve complex issues around patient trial participation. Develops SOPs in collaboration with research and clinical teams.
• Due to expertise in subject matter, functions in a lead role as a resource for research staff. Conduct protocol-specific training for study personnel to include training of staff in preparation for study activities Review protocols and provide input on study activities in relation to areas of responsibility. May work with SRL to determine study recruitment and enrollment goals. Oversees subject recruitment and study enrollment to meet goals. Leads efforts to find effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials Assists SRL in feasibility assessments and study selection

Trial Eligibility Review Specialist Job Responsibilities:

• Responsible for the review of all patient records and study assessments to determine eligibility for clinical trial participation
• Works closely with RMCC providers and clinical staff to ensure required records and documents are present in the EMR and other study-specific systems
• Maintains access to hospital records systems and all sponsor systems required to review records and assessments required for eligibility
• Provides ongoing reporting to management on trends or eligibility concerns identified in during regular participant reviews
• Provides review of previous study enrollments to support audit readiness in an ongoing manner.
• Works with management team on ongoing projects to support audit readiness, ongoing education of team members, development of appropriate SOP’s and work instructions to support same