JOB TITLE: Clinical Research Coordinator RN
POSITION STATUS: Exempt
GENERAL STATEMENT OF DUTIES: A Clinical Research Coordinator RN is responsible for all aspects of clinical treatment trials in accordance with HOA policies and procedures, federal and international regulations regarding the conduct of research involving human subjects, including but not limited to: study evaluation and initiation, subject screening and recruitment, timely and accurate data collection and submission.
Responsible for protocol evaluation and feasibility, including budget evaluation and trial preparation involving the planning, development and evaluation of patient information and patient recruitment materials. Prepares for and participates in study visits with clinical trial monitor, sponsor, and auditors.
Responsible for preparation of required forms and materials for initial and continuing Institutional Review Board (IRB) review, tracks and completes all regulatory-related processes, including reporting of adverse events on assigned studies.
Provides professional nursing care for Hematology-Oncology Associates' patients participating in clinical trials following established standards and practices.
JOB REQUIREMENTS: Strong verbal and written communication skills
Strong interpersonal skills; enjoys collaboration; works well with patients and colleagues
Ability to work in teams
Ability to work autonomously
Strong critical thinking and problem solving skills
Strong organizational skills
Attention to detail
Ability to set priorities and reprioritize quickly
Advanced computer skills/high comfort level with technology/electronic medical records
SUPERVISION RECEIVED: Reports directly to Lead Research RN
SUPERVISION EXERCISED: None
TYPICAL PHYSICAL DEMANDS: Requires full range of body motion including handling and lifting patients, manual and finger dexterity and eye-hand coordination. Requires standing and walking for extensive periods of time. Requires corrected vision that allows for accessing computer data, and hearing must be in the normal range for telephone contacts. Work may require sitting for long periods of time; also stooping, bending and stretching for files and supplies. Occasionally lifting files or paper weighing up to 30 pounds. Requires manual dexterity sufficient to operate a keyboard, type at 30 wpm, operate a calculator, fax machine, telephone, copier, and such other office equipment as necessary. It is necessary to view and type on computer screens for long periods. May be asked to travel between sites on a daily basis; must have own transportation.
TYPICAL WORKING CONDITIONS: Requires working under stressful conditions or working irregular hours. Exposure to communicable diseases, bodily fluids, toxic substances, ionizing radiation, medicinal preparations and other conditions common to a clinic environment.
EXAMPLES OF DUTIES: (This list may not include all of the duties assigned).
- Provides general nursing care to patients as needed/related to participation in clinical trial(s)
- Prepares equipment and aids physician during treatment, examination, and testing of patients participating in clinical trials
- Dispenses study and study-related medication as appropriate; provide “3rd” check” in pharmacy by initialing the (Drug Accountability Reconciliation Form) DARF
- Responds to and refers incoming telephone calls; instructs patient and family regarding study protocol, medications/interventions and protocol treatment instructions
- Recognize normal and abnormal laboratory findings and the pathology involved
- Maintain source documents; documents and maintains accurate information in OncoEMR and OncoTrials
- Performs patient teaching as required
- Reviews new consult patient charts via OncoTrials for potential clinical trial eligibility in designated disease-site areas
- Coordinates appointments (labs, imaging, vascular access etc.,) per protocol with advanced practice staff and physicians
- Reviews consent document with patients and family; including potential side effects of study medication/treatment interventions and answers any questions about the protocol
- Maintains close contact with physician and team to ensure protocol therapy is administered at the correct dose and frequency, dose modifications are implemented when indicated, and adherence to protocol testing requirements is maintained
- Assists physician/AP staff with entering orders for protocol therapy and oversees protocol guidelines for pre-medication and other supportive medications used for symptom management
- Assists the Infusion Center nursing staff, physicians and AP staff in evaluation toxicities using Common Toxicity Criteria for Adverse Events (CTCAE)
- Assist physician, and advanced practice in determining protocol required dose modifications
- Educates staff on investigational agents, proper administration of medication and potential side effects
- Promotes and educates nursing and advance practice staff on new protocols as appropriate/requested
- Evaluates patient’s compliance to protocol therapy on an ongoing basis
- Reporting and completing required documentation of adverse events/drug reactions according to CTEP-AERS designated procedures
- Assists non clinical research staff with interpretation of operative and pathology reports, reviewing medication, and medical information involving concomitant disease
- Register protocol patients with the appropriate statistical center/sponsor EDC
- Initiation and updating of patient calendars using electronic chart and/or Microsoft excel
- Log data submission date onto Excel spread sheet (on the follow up list)
- Construct, revise, edit and “run” weekly report (pod list) with scheduled clinical trials patients and distribute to research staff
- Provides ongoing support and education of staff as needed
- Participates in the selection process and orientation of new staff.
- Reviews all charts for treatment patients for adherence to protocol prior to infusion
- Attends required meetings and participates in committees as requested
- Participates in professional development activities and maintains professional affiliations
- Maintains patient confidentiality
- Request or provide final eligibility check with, CRC, physician, or AP staff
- Verify documented institutional review board approval prior to consenting a patient to protocol
- Ascertain eligibility requirements of protocol have been met including informed
consent prior to registration
- Document in patient’s electronic chart a record of patient consenting process on the day that consent occurs
- Assists with coordinating various site visits and audits
- Distributes/administers and/or collects patient questionnaires, assuring accurate completion of
- Communicates with patients at appropriate intervals in accordance with established protocol
- Create new protocol notification
- Initiate insurance review letters
- Prepares “separation of allowable charges” document for new protocols
- Monitor and respond to Research Inbox throughout the day and respond in a timely manner
- Assess all patients on clinical trials at study visit when feasible to assess for adverse events. When not possible, MD, NP or staff RN may assess pt for adverse events using CTCAE criteria
- Assists with organization of clinical trial-related lab kits/materials and ensure proper specimens are obtained, processed and shipped per assigned protocol.
- Assists with submission of all required documents to appropriate IRB for approval
- Follows IRB specific reporting requirements
- Maintains records of all submission, correspondence and actions taken at the IRB in the regulatory files
- Provides sponsors/cooperative groups with IRB approvals and correspondence to and from the IRB as requested/required
- Submits serious adverse events/IND safety reports, protocol deviations, permanent protocol closure notices to IRB per FDA/IRB guidelines
- Submits local serious adverse events to IRB for assigned protocols
- Responds to IRB inquires and makes revisions if requested by the IRB for assigned protocols
- Communicates effectively with research personnel, pharmacy, clinical staff, physicians to inform them of changes to protocols, consents, safety issues, or other changes effecting study administration
- Carries out any pharmaceutical start-up tasks, including assisting with site surveys and budget negotiations
- Assists with central IRB documentation and submits reports, etc to central IRB’s as required
- Assists with updates to OncoEMR, OncoTrials, internal databases, and intranet with updated protocol/consent information, and IRB approval dates.
- Attends local IRB meetings as requested and presents items for review and answers questions with/without principal investigator/sub-investigator .
- Assists with submission of new protocols and consents (modified as required by IRB guidelines) to IRB for review and approval
- Assists with preparation of continuing review reports for approved protocols according to IRB guidelines
- Assists with preparation of updates, amendments, revisions to IRB for review and approval according to cooperative group/sponsor/IRB guidelines
Knowledge, Skills, & Abilities:
- Demonstrates knowledge of professional nursing theory and practice to give and evaluate patient care
- Demonstrates knowledge of organizational policies, regulations and procedures to administer patient care
- Demonstrates knowledge of medical equipment and instruments to administer patient care.
- Demonstrates knowledge of common safety hazards and precautions to establish a safe work environment.
- Demonstrates skill in applying and modifying the principles, methods, and techniques of professional nursing to provide on-going patient care.
- Demonstrates skill in identifying problems and recommending solutions.
- Demonstrates skill in preparing and maintaining records, writing reports, and responding to correspondence
- Demonstrates advanced computer skills/high comfort level with technology/electronic medical records
- Demonstrates skill in developing and maintaining department quality assurance
- Demonstrates skill in establishing and maintaining effective working relationships with patients, medical staff, and the public
- Demonstrates ability to maintain quality control standards
- Demonstrates ability to react calmly and effectively in emergency situations
- Demonstrates ability to interpret, adapt and apply guidelines and procedures.
- Ability to communicate clearly.
Education: Graduate of an accredited school of nursing
Experience: Five years of professional nursing experience in hospital or oncology practice setting preferred.
Certificate/License: Possession of a New York State Registered Nurse license.
BLS Certification required
ACLS certification recommended
Certified Clinical Research Associate (CCRA) or Certified Clinical Research Coordinator (CCRC) desirable at time of hire; must obtain within three years of employment
OCN certification required within five years of employment.
ALTERNATIVE TO MINIMUM QUALIFICATIONS: None