Job Description

Employment Status:
Full time
Job Function:
Clinical Professional
Department:
314402 Clinical Research-WRMC-Tech
Shift Hours / Days:
Monday- Friday, 8:00am - 5:00pm
Hours / Pay Period:
80

We Fight Cancer: Care That Never Quits®

Cancer Treatment Centers of America® (CTCA®) delivers an extraordinary patient experience we call Patient Empowered Care®. We deliver state-of-the-art, high quality care through an integrative model where a team of experts puts patients at the center of their own care. Every day, you will help patients win the fight against cancer. Every day is challenging and rewarding beyond your imagination.

A Culture of Teamwork, Empowerment & Development

CTCA provides Stakeholders with exceptional support and easy access to a wide range of tools and resources they need to bring the best of themselves, every day. Our benefits, wellness, and compensation programs lead the market. We provide extensive training and career development opportunities that encourage professional and personal growth—it is a point of pride. We empower our Stakeholders to deliver the highest standard of care, which we call the Mother Standard®.

Job Summary/Purpose:

Under direct supervision of the Director, Clinical Research and/or Research (Nurse) Manager, the incumbent will coordinate phase I through III oncology research studies and be responsible for maintaining and assuring protocol compliance for all research subjects. This role is responsible for regulatory and compliance documentation including protocol training for the clinic staff, imaging department and infusion center, test article accountability, and IRB transactions. Additional responsibilities include establishing relationships with outside providers for required tests not available in-house. The Specialist, Clinical Research must demonstrate an in-depth knowledge of applicable federal regulations, institutional guidance documents and SOPs for the conduct of clinical trials to ensure human subject protection, compliance with protocol and regulatory requirements and the thorough collection, recording and maintenance of data and source documentation.

The Specialist, Clinical Research collaborates with physicians/investigators in review of potential protocols and in research subjects’ recruitment and screening for protocol eligibility and is responsible for developing an individualized strategy for identifying potentially eligible patients for each study.  The Specialist, Clinical Research presents trial concepts and details to the research subjects, participates in the informed consent process, enrolls and coordinates care of subjects in compliance with protocol requirements.  The Specialist, Clinical Research may provide teaching on investigational agents/devices to research subjects and maintains test article accountability. In collaboration with physicians/investigators, the Specialist, Clinical Research monitors subjects for changes in condition, adverse events, concomitant medication use, protocol compliance, response/reactions to test articles, and thoroughly documents all findings. The Specialist, Clinical Research is responsible for accurate and timely data collection, documentation, and reporting and entering all patient data in CTMS. The Specialist, Clinical Research is responsible for identifying research charges on patient bills. The Specialist, Clinical Research schedules and/or participates in off-site investigator meetings, pre-site selection visits, site-initiation visits, site-assessments, monitoring visits, and auditing activities as delegated by the Research (Nurse) Manager and/or Director, Clinical Research. The Specialist, Clinical Research may be responsible for and/or assist with completion and maintenance of regulatory documents in accordance with regulations, hospital and organizational policies and Standard Work Instructions. The Specialist, Clinical Research will participate in required training and education programs, provide clinical research education to local clinic staff, and ensure site research quality by practicing in compliance with policies, SWIs, principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. The Specialist, Clinical Research may develop or assist with development of study tools including source documents and eligibility checklists and criteria cards and may be involved in the collection, processing, and shipping of protocol required lab specimens. The Specialist, Clinical Research maintains adequate supplies to conduct the studies and orders replacements as needed, maintains the equipment inventory (per protocol) and has appropriate certifications as required by protocol activities e.g., IATA certification). The Specialist, Clinical Research assists clinicians (LPNs, MAs, and/or RNs) as needed to ensure that protocol-required specimen collections, electrocardiograms, vital signs, study drugs and customary usual care medications, IV start and IV discontinuation as well as follow-up observations are performed per protocol (as applicable).  The Specialist, Clinical Research may work in collaboration with Regulatory Coordinators, Data Coordinators, and Clinical Research Nurses as scope of work and project demands dictate.

Job Responsibilities:

Study Management:

  • Collaborate with physicians/investigators in review of potential protocols

  • Schedule and participate in site qualification, initiation and monitoring visits, audit activities

  • Provide clinical research education to local stakeholders

  • Direct ancillary department staff, non-medical staff, and fellows in study execution

  • Coordinate activities between departments, outlying facilities, research personnel

  • Develop study tools, source documents, eligibility checklists, criteria cards

  • Act as a liaison between Investigators, primary care providers, alternative therapy providers, clinical staff and the IRB and sponsors to ensure priorities are clearly communicated and resources are allocated appropriately across multiple ongoing projects.

  • Assist Investigators and clinical staff in the identification, recruitment and enrollment strategies of research subjects to meet recruitment goals and contract obligations.

  • Assist Investigators in organizing study data for progress reports/ analyses, conference presentations and publications.

Protect Human Subjects:

  • Recruit, screen prospective subjects to determine eligibility and enroll eligible subjects in clinical trials

  • Execute informed consent process including appropriate discussions to: educate subjects about the study protocol and test article(s); explain the rights of research subjects; answer subjects’ questions; and obtain written documentation of voluntary consent

  • Coordinate research subject care (clinic appointments, laboratory schedules, procedures, etc.) to ensure protocol compliance

  • Monitor subjects for adverse events through analysis of clinical reports, laboratory and imaging results, and subject interviews

  • Act as a liaison between Investigators, primary care providers, alternative therapy providers, and clinical staff to ensure subject enrollment and research activities (ongoing study visits) comply with the established protocols, regulatory and monitoring agency standards, and sponsor guidelines

  • Observe clinic procedures, review laboratory and diagnostic testing results for data collection, appropriate reporting, and protocol compliance

  • Perform research required activities within scope of technical expertise and training including vital signs, blood draws, collection, processing and shipping of biospecimens, subject and rater surveys, and clinical observations

  • Identify and inform physicians, clinical staff, affiliates and sponsors of adverse events, deviations and protocol modifications, including their impact on the clinical research and locally enrolled subjects.

Prepare and maintain research regulatory compliance and documentation:

  • Perform timely and accurate IRB reporting, (protocol, ICF, amendments, IND safety reports, etc)

  • Coordinate the activation and maintenance of clinical protocols, including review and completion of submissions, amendments, and adverse event reports as required by the IRB Sponsors.

  • Create and maintain regulatory files for all required documents including IRB Registration, IRB Roster, IRB Letter of Assurance/FWA Number, test article accountability, gathering and maintaining laboratory normal and certifications, staff training logs, and monitoring visits.

Preserve the integrity of clinical research data:

  • Document and report adverse and unanticipated events to the investigator, regulatory specialist, sponsor, and the IRB as appropriate

  • Ensure data collection and data entry into CRFs.

  • Performs timely and accurate data edits and query resolution

Participate in departmental administrative activities:

  • Orient and train new Stakeholders

  • IIT data collection and analysis for publication, abstracts, presentation, professional meetings

Minimum Qualifications:

Required:

  • Bachelor's degree in a healthcare or business-related field with healthcare experience (Business Administration, Health Care Administration, clinical field (science, health, medicine, pharmacy, nursing), OR equivalent experience
  • Minimum of 2 years of research experience
  • Minimum of 2 years clinical experience
  • Certification through SoCRA, ACRP, or other reputable entity within 3 years
  • Basic Life Support (American Heart Association) Certification within 6 months
  • Human Subjects Protection training/certification within 90 days
  • Availability for off hours coverage and occasional travel
  • Basic Oncology class within 1 year of employment.

Preferred:

  • 3+ years of research experience
  • 3+ years of clinical oncology experience
  • Master’s degree in a healthcare or business-related field with healthcare experience (Business Administration, Health Care Administration, clinical field (science, health, medicine, pharmacy, nursing)
  • Certification through Society of Clinical Research Associates, Association of Clinical Research Professionals, or other reputable entity
  • Phase I clinical research experience

The Best Place to Work

We call ourselves Stakeholders because we all have a stake in the care and success of every patient. Today, CTCA Stakeholders deliver healing and hope to patients fighting complex and advanced cancer in Atlanta, GA, Chicago, IL, Philadelphia, PA, Phoenix, AZ and Tulsa, OK.  Each of our hospitals earned a Best Place to Work distinction and receives numerous accreditations that celebrate our culture of clinical quality, innovation, high performance and wellness.

Beyond The Resume, What We Look For

We select people with talent—people who thrive in an environment of continuous improvement. We are creative and resourceful problem solvers. We are inventors and innovators. As a CTCA Stakeholder, you make the difference in the life of a patient.

Do you see yourself working with a passionate team in a dynamic, high growth environment?  Visit www.cancercenter.com/careers  to begin your journey.