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Job Description
JOB SUMMARY
The IMMUNOe Registered Nurse Research Coordinator is involved in all medical aspects of clinical trials research including performing infusions, venipuncture, vital signs, ECGs, etc., and includes direct involvement in case management of study participants. Works under the supervision of the Principal Investigator and Site Manager.
ESSENTIAL FUNCTIONS
Review with the Principal Investigator the inclusion/exclusion criteria, overall structure and requirements of each protocol Perform medical procedures within the scope of license including infusions, vitals, phlebotomy, ECGs, injections, etc. Organize, facilitate, and implement research activities across multiple studies of different therapeutic areas and phases Develops an understanding of, and completion of training in ICH/GCP guidelines, HIPAA, Standard Operating Procedures, IATA, and technical skills trainings. Other trainings may be required Develops an understanding of the Investigator and Site responsibilities in regards to FDA, DHHS, and OHRP regulations Develops an understanding of the Drug Development Process (IND to NDA and IDE to PMA, if applicable, and Phase I to Phase IV) Develops an understanding of the elements of the Informed Consent Form in regards to the Declaration of Helsinki and the various aspects of the informed consent process Possess a basic knowledge of Institutional Review Boards Regulations and their role in clinical trials Completes study visits including but not limited to: Successfully recruit and retain patients through appropriate measures Obtain and ensure that the informed consent process has occurred properly prior to any research related procedures being performed Review medical records and inclusion/exclusion criteria with assistance of the Principal Investigator, Sub-Investigator or the Site Manager Perform safety assessments including venipuncture, vital signs, ECG, etc. Assists in creation of source documentation Source Documentation completion Schedule subjects and maintain and document adequate follow-up with study subjects, physicians and sponsors Collaborate with clinical staff to ensure procedures required by the clinical protocol are performed and documented Complete Case Report Forms and manage query resolution in an accurate and timely manner Maintain essential documents in the regulatory binder Recognizes and defines safety events (serious adverse events and adverse events) and promptly notifies appropriate parties, with assistance Prepares, attends and participates in site initiation meetings, as well as interim monitoring and closeout visits Attends sponsor Investigator / Coordinator meetings as needed for assigned protocols Participates in peer review of data quality Adheres to employee policies and procedures per the IMMUNOe handbook Required to follow all protocol guidelines and standard procedures for all areas of research.
MANAGEMENT RESPONSIBILITIES
None
REQUIRED EDUCATION
RN, BSN, NP
REQUIRED EXPERIENCE
At least two years' experience in a clinical setting (e.g. hospital, physician or group practice, etc.) MUST have 2 to 5 years of previous
CLINICAL
Research experience. MUST be a RN with current Colorado License; Experience with Infusions preferred Certification in an applicable field (e.g. CCRC, CCRA, or CCRP) is preferred
REQUIRED SKILLS
• Clinical skills of phlebotomy, basic laboratory testing, intravenous infusion and ECG are required •Expected to possess and maintain current CPR, (BLS or ACLS) training. Strict attention to detail Exceptional organization skills Strong written and communication skills Ability to manage multiple studies simultaneously Basic computer skills Honesty and integrity High level of professionalism Ability to work effectively as part of a high-performance work team A thorough understanding of regulatory requirements including ICH/GCP guidelines, FDA, DHHS, and OHRP regulations
EQUIPMENT USED
Including but not limited to various models of infusion pumps, sphygmomanometer, ECG machine, pulmonary function equipment, various laboratory equipment
PHYSICAL/MENTAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
JOB SUMMARY
The IMMUNOe Registered Nurse Research Coordinator is involved in all medical aspects of clinical trials research including performing infusions, venipuncture, vital signs, ECGs, etc., and includes direct involvement in case management of study participants. Works under the supervision of the Principal Investigator and Site Manager.
ESSENTIAL FUNCTIONS
Review with the Principal Investigator the inclusion/exclusion criteria, overall structure and requirements of each protocol Perform medical procedures within the scope of license including infusions, vitals, phlebotomy, ECGs, injections, etc. Organize, facilitate, and implement research activities across multiple studies of different therapeutic areas and phases Develops an understanding of, and completion of training in ICH/GCP guidelines, HIPAA, Standard Operating Procedures, IATA, and technical skills trainings. Other trainings may be required Develops an understanding of the Investigator and Site responsibilities in regards to FDA, DHHS, and OHRP regulations Develops an understanding of the Drug Development Process (IND to NDA and IDE to PMA, if applicable, and Phase I to Phase IV) Develops an understanding of the elements of the Informed Consent Form in regards to the Declaration of Helsinki and the various aspects of the informed consent process Possess a basic knowledge of Institutional Review Boards Regulations and their role in clinical trials Completes study visits including but not limited to: Successfully recruit and retain patients through appropriate measures Obtain and ensure that the informed consent process has occurred properly prior to any research related procedures being performed Review medical records and inclusion/exclusion criteria with assistance of the Principal Investigator, Sub-Investigator or the Site Manager Perform safety assessments including venipuncture, vital signs, ECG, etc. Assists in creation of source documentation Source Documentation completion Schedule subjects and maintain and document adequate follow-up with study subjects, physicians and sponsors Collaborate with clinical staff to ensure procedures required by the clinical protocol are performed and documented Complete Case Report Forms and manage query resolution in an accurate and timely manner Maintain essential documents in the regulatory binder Recognizes and defines safety events (serious adverse events and adverse events) and promptly notifies appropriate parties, with assistance Prepares, attends and participates in site initiation meetings, as well as interim monitoring and closeout visits Attends sponsor Investigator / Coordinator meetings as needed for assigned protocols Participates in peer review of data quality Adheres to employee policies and procedures per the IMMUNOe handbook Required to follow all protocol guidelines and standard procedures for all areas of research.
MANAGEMENT RESPONSIBILITIES
None
REQUIRED EDUCATION
RN, BSN, NP
REQUIRED EXPERIENCE
At least two years' experience in a clinical setting (e.g. hospital, physician or group practice, etc.) MUST have 2 to 5 years of previous
CLINICAL
Research experience. MUST be a RN with current Colorado License; Experience with Infusions preferred Certification in an applicable field (e.g. CCRC, CCRA, or CCRP) is preferred
REQUIRED SKILLS
• Clinical skills of phlebotomy, basic laboratory testing, intravenous infusion and ECG are required •Expected to possess and maintain current CPR, (BLS or ACLS) training. Strict attention to detail Exceptional organization skills Strong written and communication skills Ability to manage multiple studies simultaneously Basic computer skills Honesty and integrity High level of professionalism Ability to work effectively as part of a high-performance work team A thorough understanding of regulatory requirements including ICH/GCP guidelines, FDA, DHHS, and OHRP regulations
EQUIPMENT USED
Including but not limited to various models of infusion pumps, sphygmomanometer, ECG machine, pulmonary function equipment, various laboratory equipment
PHYSICAL/MENTAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Job Type:
Full-time Pay:
$33.00 - $45.00 per hour
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Life insurance Paid time off Vision insurance
