We are, a freestanding, physician-owned, comprehensive cancer center based in Albuquerque, NM with a satellite clinic in Gallup, New Mexico. We are an Oncology Medical Home, with a focus on early intervention for patient symptoms, resulting in low hospitalization rates. Our Physicians have won Top 10 Docs in the city of Albuquerque multiple times.
As a successful Medical oncology and Radiation oncology practice, we have expanded our medical practice to include Survivorship, Palliative Care, Primary Care, Rheumatology, Pulmonary, Urology, Breast Surgery and Neurology.
Make a difference in the lives of patients by joining a physician-led, partnership organization with a patient-centered and evidenced-based medicine approach. You will have the tools, resources, and professional freedom you need to deliver outstanding patient care.
POSITION SUMMARY:
Reporting to the Clinical Research Manager, NMOHC’s research coordinator will be primarily responsible for ensuring that clinical trials are conducted according to the investigational plan and all applicable regulations while protecting the rights, safety and welfare of research patients under their care. The position arranges and oversees all clinical trial activities and plays a key role in assisting the Principal Investigator (PI) in recruiting patients for clinical studies. The position works closely with the Principal Investigator, NMOHC, members of the department, study sponsors and monitors, to support and provide protocol execution exercising Good Clinical Practices and observing compliance with FDA and ICH guidelines. Performs additional support activities as assigned. Working collaboratively with other Clinical Research Coordinator’s and Clinical Research Manager.
SPECIFIC RESPONSIBILITIES:
- Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
- Schedules study participant appointments and serves as the patient liaison to the PI and other participating physicians and medical services required by the protocol.
- Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
- Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment.
- Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) in order to be able to answer all questions pertaining to the study posed during the informed consent process.
- Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits.
- Completes case report forms. Extracts data from patient charts in a timely manner.
- Responds to data clarification requests in a timely manner.
- May attend Investigator meetings requiring travel and report pertinent information back to research team members.
- Coordinates with PIs and NMOHC to help ensure that clinical research and related activities are performed in accordance with Federal regulations, BFS and sponsoring agency policies and procedures.
- Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan.
- Maintains records and other documentation of training.
- Maintains subject screening logs and protocol deviation logs.
- Maintains a spreadsheet tracking updates to database of all subjects enrolled on clinical trials.
- Coordinates and facilitates monitoring and auditing visits. Notifies appropriate network officials of external audits by IRB’s, Regulatory agencies, CRO’s and sponsors.
- Collaborates with PI and NMOHC to respond to any audit findings and implement-approved recommendations.
- Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis.
- Ensures that all materials for each clinical trial protocol are available for subject enrollment.
- Works collaboratively with the other members of the clinical research team and the clinical and NMOHC to ensure all protocols are followed and that there is timely documentation and submission of study data.
- Performs specimen processing and shipment of biological specimen duties.
- Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
- Establishes and organizes study files, including but not limited to, site regulatory binders, study specific source documentation and other materials as required.
- Develop a recruiting program within the clinics associated with the site
- Assist with the development and design of data collection forms/tools (checklists, calendars, tracking logs etc.) in accordance with the study protocol and established clinical and data management standards
- Perform QA and QC review of data, identify quality and performance improvement opportunities and collaborate with research team in the development of action plans to improve quality
- Responsible for ordering and maintaining research supplies, compiling research charts, preparing source documents and assisting in the investigational drug accountability process
- Participate in required training and education programs
- Maintain research records in a confidential manner according to practice policies, sponsor confidentiality agreements, HIPAA guidelines, and any other applicable regulations
ADDITIONAL RESPONSIBILITIES:
- Performs other duties as assigned
- Works efficiently and conscientiously as part of a team in a fast-paced, stressful environment
EDUCATION AND EXPERIENCE:
- High School Diploma or GED
- Preferred: Two to three years clinical research experience
- Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.
- To be certified by Association of Clinical Research Professionals or agree to work toward certification upon eligibility.
- Knowledge of medical terminology.
- Knowledge of GCP/ICH, FDA, OHRP, HIPAA policies
- PC and Microsoft Office skills
- Must have excellent written and verbal communication skills and the ability to maintain confidentiality
- Previous work with CRFs and EDC.
- Excellent organizational skills to independently manage workflow.
- Ability to prioritize quickly and appropriately.
- Ability to multi-task.
- Meticulous attention to detail
Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Paid time off
- Retirement plan
- Vision insurance
Application Question(s):
- Are you currently on a STEM Program Visa?
Work Location: In person
