Job Description

Employment Status:
Full time
Job Function:
Business Professional
Department:
314102 Clinical Research-MRMC-Tech
Shift Hours / Days:
Mon - Fri 8am - 5pm, some flexibility, some wknds/holidays
Hours / Pay Period:
80

Clinical Research Specialist

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.

Minimum Qualifications:

  • 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 research experience

  • Certification through SoCRA, ACRP, or other reputable entity within 3 years

  • Basic Life Support training 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.

Essential Physical Requirements:

  • Lifting up to 10 lbs

  • Prolonged standing, sitting, walking

  • Prolonged eye strain through work, concentration, or focusing

  • Ability to perform fine manipulation (keyboard)

  • Good visual acuity, acute hearing and ability to identify different colors are required

  • Push/pull of light objects, ie. carts

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.

#LI-RM1