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Coordinator, Nurse Clinical Trials - Townpark
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Kennesaw, GA Kennesaw, Georgia |
About this job
Description: Under the direction of the Clinical Trials Manager and the Clinical Trials Site Supervisor, assists in ensuring the integrity and quality of the clinical trial(s) are maintained and conducted in accordance with federal, state, and local regulations, Institutional Review Board (IRB) approvals, and Kaiser Permanente (KP) policies and procedures. With the direction of the Principal Investigator (PI), this position coordinates research activities as outlined in the Major Responsibilities below. Serves as the first point of contact by telephone and mail with the study participants for recruitment, scheduling of visits, protocol adherence and retention. Travels to other medical office buildings. This position is also responsible for protecting the health, safety, and welfare of clinical trial participants.
Essential Responsibilities:
Study Implementation. Utilizes nursing skills to coordinate research-related activities (e.g., scheduling study visits, assisting with nursing assessments of participants, adverse events, and data collection including laboratory and diagnostic studies).
Manages visits with the sponsoring companies and assists in the initiation of clinical trials.
With direction, participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development in the conduct of clinical trials.
With supervision and direction by PI and/or designee, plan recruitment procedures for potential participants.
Assist in the determination of eligibility of candidates for study participation.
Assist in the enrollment of subjects into the trial (screening, randomization, and data collection) and any study-related procedures as required by the protocol.
Participate in the ongoing informed consent process with the PI to ensure the research participants and their families have their questions answered.
Assist with the study completion, resolution of data queries, data lock, study closeout, and archiving of study files.
Provide regulatory support to ensure proper maintenance and storage of critical documents required to be maintained and provided to the sponsor during the conduct of the trial.
Support the effective financial management of the clinical trial.
Perform nursing procedures required in the protocol in accordance with the scope of practice and the Georgia State Board of Nursing Standards.
Coordinate and perform packaging and shipping of protocol specimens to the sponsor lab in accordance with IATA/DOT regulations and sponsor shipping guidelines, if applicable.
Serves as liaison between the site, PI, study participant and study sponsor for assistance with questions, adverse events and communicating information.
Report all protocol violations/deviations and adverse events to the PI in a timely manner to ensure the health, safety and welfare of the participants.
Performs accurate data collection, management and reporting including timely communication of study-related changes and serious adverse events with the sponsor and Kaiser Permanente's Institutional Review Board (IRB).
With supervision, utilize and document the nursing procedures to plan, deliver, and evaluate research care for non-complex medical conditions and, with appropriate assistance, for complex medical conditions.
Performs timely completion of data entry on the case report forms (CRF) and query response.
Accurately and completely record information in the source documents in a timely manner.
Leadership and Communication. With guidance from the PI, communicates with and educates the research participant about study activities and requirements as needed.
When applicable and with supervision, coordinate IRB communications (e.g., new protocols, amendments, modifications, continuing review applications, protocol violations, and adverse events) in accordance with institutional and departmental policies and procedures.
Education and Training. With direction, participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development as a clinical trials nurse participating in the conduct of clinical trials. Work with an assigned mentor on a regular basis for training and resource questions.
Participate as a member of the clinical trials team and attend meetings, as requested.
Attend meetings for protocol training initiated by KP and the Sponsor, as requested.
Compliance. Support and comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct).
With guidance, assist with ensuring compliance with KPGA IRB approved protocols.
Adhere to Guideline for Good Clinical Practice (GCP), federal, state, and local regulations, and KP policies and procedures.
Assists with any internal/external compliance monitoring and/or audits and inspections to protect research participants, assure operational effectiveness of the program and to reduce risks to the organization.
Ensures the clinical trials records and files are maintained in an audit readiness manner and are in compliance with federal and FDA regulations, guidelines to Good Clinical Practice (GCP) and Kaiser Permanente's policies and procedures.
Assists with the maintenance of systems and resources for the effective communication and submission of required documentation to the IRB.
Adhere to departmental policies and procedures to ensure confidentiality, privacy and security of clinical research interactions and participant information, and responsible use of operational research databases in compliance with KP policies.
Adhere to departmental policies and procedures to support high-quality implementation and conduct of trials, and assure maintenance of research activities and documentation in compliance with the protocols and KP policies and procedures.
Quality Improvement. With direction, perform routine quality control activities and assist with quality improvement initiatives.
General. May perform other duties as assigned by appropriate management.
Travel to the Regional office and other medical office buildings required for education/training, participant recruitment, participant study visits, and meetings.
Basic Qualifications:
Experience
Minimum two (2) years of recent clinical nursing experience in a hospital, clinic or similar health care setting required. Education
Associate's degreeOR two (2) years of experience in a directly related field.
High School Diploma or General Education Development (GED) required. License, Certification, Registration
Current licensure as a Registered Professional Nurse in the State of Georgia or able to obtain prior to date of hire.
Additional Requirements:
Effective listening, verbal, and written communication skills.
Local travel between KP clinical sites as required. Travel out of state as requested.
Must be proficient in electronic health systems and databases used in research environment, or willingness to learn and demonstrate proficiency within six months of hire.
Demonstrate effective written, verbal, and interpersonal communication skills.
Attention to detail and accuracy.
Ability to manage multiple tasks with time deadlines.
Demonstrate prioritization and organizational skills.
Proficient in medical terminology.
Demonstrate basic drug calculation skills.
Demonstrate problem-solving skills.
Demonstrate nursing competency skills per scope of practice (i.e., phlebotomy, performing vital signs, nursing assessments, urine dipstick reading, pregnancy test reading, performing EKG, etc.) with certification if applicable. Other (specific to relevant therapeutic area).
Knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures.
Experience with FDA-regulated clinical trials is required.
Ambulatory care experience.
Medication management experience.
Clinical Research involving human subjects.
Data entry and reporting on a computer.
Prior data collection experience (chart abstraction).
Certification in Human Subjects Protection (post hire).
Preferred Qualifications:
Minimum two (2) years of research related experience in clinical trials.
Bachelor's degree in Nursing.
Primary Location: Georgia,Kennesaw,Town Park Medical Offices I 750 Townpark Ln. Scheduled Weekly Hours: 40 Shift: Day Workdays: Mon-Fri Working Hours Start: 8:00 AM Working Hours End: 4:00 PM Job Schedule: Full-time Job Type: Standard Employee Status: Regular Employee Group/Union Affiliation: Salaried, Non-Union, Exempt Job Level: Entry Level Job Category: Research and Development Department: KPGA Center for Clinical & Outcomes Research Travel: Yes, 15 % of the Time
Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with federal and state laws, as well as applicable local ordinances, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.
Click here for additional requirements >
Essential Responsibilities:
Study Implementation. Utilizes nursing skills to coordinate research-related activities (e.g., scheduling study visits, assisting with nursing assessments of participants, adverse events, and data collection including laboratory and diagnostic studies).
Manages visits with the sponsoring companies and assists in the initiation of clinical trials.
With direction, participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development in the conduct of clinical trials.
With supervision and direction by PI and/or designee, plan recruitment procedures for potential participants.
Assist in the determination of eligibility of candidates for study participation.
Assist in the enrollment of subjects into the trial (screening, randomization, and data collection) and any study-related procedures as required by the protocol.
Participate in the ongoing informed consent process with the PI to ensure the research participants and their families have their questions answered.
Assist with the study completion, resolution of data queries, data lock, study closeout, and archiving of study files.
Provide regulatory support to ensure proper maintenance and storage of critical documents required to be maintained and provided to the sponsor during the conduct of the trial.
Support the effective financial management of the clinical trial.
Perform nursing procedures required in the protocol in accordance with the scope of practice and the Georgia State Board of Nursing Standards.
Coordinate and perform packaging and shipping of protocol specimens to the sponsor lab in accordance with IATA/DOT regulations and sponsor shipping guidelines, if applicable.
Serves as liaison between the site, PI, study participant and study sponsor for assistance with questions, adverse events and communicating information.
Report all protocol violations/deviations and adverse events to the PI in a timely manner to ensure the health, safety and welfare of the participants.
Performs accurate data collection, management and reporting including timely communication of study-related changes and serious adverse events with the sponsor and Kaiser Permanente's Institutional Review Board (IRB).
With supervision, utilize and document the nursing procedures to plan, deliver, and evaluate research care for non-complex medical conditions and, with appropriate assistance, for complex medical conditions.
Performs timely completion of data entry on the case report forms (CRF) and query response.
Accurately and completely record information in the source documents in a timely manner.
Leadership and Communication. With guidance from the PI, communicates with and educates the research participant about study activities and requirements as needed.
When applicable and with supervision, coordinate IRB communications (e.g., new protocols, amendments, modifications, continuing review applications, protocol violations, and adverse events) in accordance with institutional and departmental policies and procedures.
Education and Training. With direction, participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development as a clinical trials nurse participating in the conduct of clinical trials. Work with an assigned mentor on a regular basis for training and resource questions.
Participate as a member of the clinical trials team and attend meetings, as requested.
Attend meetings for protocol training initiated by KP and the Sponsor, as requested.
Compliance. Support and comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct).
With guidance, assist with ensuring compliance with KPGA IRB approved protocols.
Adhere to Guideline for Good Clinical Practice (GCP), federal, state, and local regulations, and KP policies and procedures.
Assists with any internal/external compliance monitoring and/or audits and inspections to protect research participants, assure operational effectiveness of the program and to reduce risks to the organization.
Ensures the clinical trials records and files are maintained in an audit readiness manner and are in compliance with federal and FDA regulations, guidelines to Good Clinical Practice (GCP) and Kaiser Permanente's policies and procedures.
Assists with the maintenance of systems and resources for the effective communication and submission of required documentation to the IRB.
Adhere to departmental policies and procedures to ensure confidentiality, privacy and security of clinical research interactions and participant information, and responsible use of operational research databases in compliance with KP policies.
Adhere to departmental policies and procedures to support high-quality implementation and conduct of trials, and assure maintenance of research activities and documentation in compliance with the protocols and KP policies and procedures.
Quality Improvement. With direction, perform routine quality control activities and assist with quality improvement initiatives.
General. May perform other duties as assigned by appropriate management.
Travel to the Regional office and other medical office buildings required for education/training, participant recruitment, participant study visits, and meetings.
Basic Qualifications:
Experience
Minimum two (2) years of recent clinical nursing experience in a hospital, clinic or similar health care setting required. Education
Associate's degreeOR two (2) years of experience in a directly related field.
High School Diploma or General Education Development (GED) required. License, Certification, Registration
Current licensure as a Registered Professional Nurse in the State of Georgia or able to obtain prior to date of hire.
Additional Requirements:
Effective listening, verbal, and written communication skills.
Local travel between KP clinical sites as required. Travel out of state as requested.
Must be proficient in electronic health systems and databases used in research environment, or willingness to learn and demonstrate proficiency within six months of hire.
Demonstrate effective written, verbal, and interpersonal communication skills.
Attention to detail and accuracy.
Ability to manage multiple tasks with time deadlines.
Demonstrate prioritization and organizational skills.
Proficient in medical terminology.
Demonstrate basic drug calculation skills.
Demonstrate problem-solving skills.
Demonstrate nursing competency skills per scope of practice (i.e., phlebotomy, performing vital signs, nursing assessments, urine dipstick reading, pregnancy test reading, performing EKG, etc.) with certification if applicable. Other (specific to relevant therapeutic area).
Knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures.
Experience with FDA-regulated clinical trials is required.
Ambulatory care experience.
Medication management experience.
Clinical Research involving human subjects.
Data entry and reporting on a computer.
Prior data collection experience (chart abstraction).
Certification in Human Subjects Protection (post hire).
Preferred Qualifications:
Minimum two (2) years of research related experience in clinical trials.
Bachelor's degree in Nursing.
Primary Location: Georgia,Kennesaw,Town Park Medical Offices I 750 Townpark Ln. Scheduled Weekly Hours: 40 Shift: Day Workdays: Mon-Fri Working Hours Start: 8:00 AM Working Hours End: 4:00 PM Job Schedule: Full-time Job Type: Standard Employee Status: Regular Employee Group/Union Affiliation: Salaried, Non-Union, Exempt Job Level: Entry Level Job Category: Research and Development Department: KPGA Center for Clinical & Outcomes Research Travel: Yes, 15 % of the Time
Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with federal and state laws, as well as applicable local ordinances, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.
Click here for additional requirements >