Clinical Research Coordinator Job at University of Kansas Medical Center
Department:
SOM KC Neurology - Neuromuscular
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Neuromuscular Staff
Position Title:
Clinical Research Coordinator
Job Family Group:
Professional Staff
Job Description Summary:
This position is responsible for working collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The Clinical Research Coordinator will manage clinical research studies by coordinating and participating in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Monitor participants' progress including documenting and reporting adverse events. Participate in periodic quality assurance audits of protocols.
Job Description:
This position is responsible for recruiting, evaluating, and educating patients regarding clinical trials related to neuromuscular disease. This position coordinates all aspects of assigned research studies including recruitment, study visit activities according to protocol, maintenance of the investigator site file, data entry, and other various tasks.
The Clinical Research Coordinator collaborates with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. This position manages assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Monitors study participants' progress including documenting and reporting adverse events. Participates in periodic quality assurance audits of protocols.
This position will be or become familiar with neuromuscular disease and conducting research according to ICH GCP guidelines.
The position requires an individual with exceptional communication skills and the ability to multi-task to work collegially with members of the neuromuscular research team to ensure research studies are being conducted according to protocol.
Job Duties
Recruits, evaluates, and educates patients regarding clinical trials related to neuromuscular disease
Conducts Informed Consent Interview with participant and caregiver following Neuromuscular Program Standard Operating Procedures (SOP) for obtaining consent from cognitively normal and cognitively impaired individuals. Follows SOP for determination of when use of a Surrogate consent form is necessary, due to extent of cognitive impairment.
Documents trial related activities per regulatory requirements in a timely and accurate manner.
Coordinates of all aspects of study visit activities for patients and families, including scheduling of hospital-based procedures such as MRI and PET, and other procedures to include clinical study visit interviews and assessments, ECG, lab draws, IV infusions, lumbar punctures, and dispensation of study medication.
Gathers accurate medical history and concomitant medication information and ensures that medical conditions and medications meet trial specifications.
Probes patient/ caregiver for any changes in health throughout clinical trial intervention and monitors for potential adverse events. Obtains complete reports of new symptoms/changes in health conditions and reviews with clinician/principal investigator. Based on principal investigator's determination of adverse event (AE) qualification, prepares formal AE report for sponsor and for IRB, when applicable per regulations. If AE meets criteria of Serious Adverse Event (SAE), prepares full FDA MedWatch or sponsor-provided Safety Report and submits to regulatory authorities within 24 hours of learning of event.
Assists physician in cerebrospinal fluid (CSF) collection for clinical trials by educating patient / caregiver regarding the lumbar puncture procedure, preparing lumbar puncture supplies, providing supplies to physician during procedure while maintaining sterile field, aliquoting CSF by protocol-specified amounts into separate vials for storage and transport, instructing patient/caregiver in post-lumbar puncture care and expectations, conducting follow -up phone call to determine if any adverse events were experienced.
Prepares local and central lab requisition forms to ensure proper testing is conducted on CSF, blood, and urine samples.
Prepares and ships biological specimens to central labs per protocol and regulatory requirements.
Conducts interviews with patient and/or caregiver regarding mood, anxiety, neurobehavioral symptoms, and functional abilities.
Ensures all study staff completes required training for proper conduct of the trial
Ensures investigator's timely review of lab tests, EMG/ECG/MRI/PET results and communicates clinically relevant information to patient and patient's primary care doctor as appropriate.
Ensures availability of medical records, updated subject records and updated protocols.
Updates and maintains regulatory binders.
Prepares adverse event reports and protocol deviation reports for submission to IRB.
Assists the Research Institute regulatory project manager in preparation of IRB submissions, including review of consent forms, new study and continuing review applications, and protocol amendments.
Ensures all study data is entered into sponsor-provided and/or internal KU databases per sponsor requirements, typically within 3 business days following data collection.
Required Qualifications
Bachelor's degree in basic science or health related field. Experience may substitute for degree on a year for year basis.
Proficiency in computer software, systems, and programs
Attention to detail, time-management skills, strong work-ethic, self-motivated, willing to learn, good interpersonal skills. Ability to interact with multidisciplinary teams including patients, families, physicians, and administrative staff.
Ability to manage multiple tasks and set priorities and meet deadlines
Excellent written and verbal communication skills
Periodic travel to attend national meetings
Preferred Qualifications
Prior health care and/or research experience.
Familiarity with electronic medical records.
Experience in Neurology and/or Neuromuscular research.
SOCRA CCRP certification
Employee Type:
Regular
Time Type:
Full time
Rate Type:
Salary
Pay Range:
$58,000.00 - $86,000.00
Minimum
$58,000.00
Midpoint
$72,000.00
Maximum
$86,000.00
Application Instructions:
To learn more and apply online, please visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Kansas-City-Metro-Area/Clinical-Research-Coordinator_JR005056 or go to https://careers.kumc.edu/ and search for position number JR005056.
Applications must be submitted directly through the KU Medical Center website to be considered for this position. Any applications submitted via email or this website will NOT be reviewed or considered.
About KU Medical Center:
The University of Kansas Medical Centers mission is to educate exceptional health care professionals through a full range of undergraduate, graduate, professional, postdoctoral and continuing education programs in the schools of Medicine, Nursing and Health Professions. KU Medical Center also advances the health sciences through world-class research programs; provides compassionate and state-of-the-art patient care in an academic medical center environment; and works with communities in every Kansas county to improve the health of Kansans. Learn more at www.kumc.edu .
Benefits:
KUMC offers a range of great benefits that support employees and eligible family members. Our health insurance benefits begin on hire date and KUMC offers other exciting benefits such as paid parental leave, generous employer retirement contributions and other resources to improve health and well-being. For more information, please visit https://www.kumc.edu/human-resources/benefits.html
Can you also include the following EEO statement on all of our advertising locations: KU is an EO/AAE. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, genetic information or protected Veteran status. http://policy.ku.edu/IOA/nondiscrimination
jeid-7b511d0968efdb4386f6871a35ce580e
Please Note :
epokagency.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, epokagency.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
SOM KC Neurology - Neuromuscular
-----
Neuromuscular Staff
Position Title:
Clinical Research Coordinator
Job Family Group:
Professional Staff
Job Description Summary:
This position is responsible for working collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The Clinical Research Coordinator will manage clinical research studies by coordinating and participating in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Monitor participants' progress including documenting and reporting adverse events. Participate in periodic quality assurance audits of protocols.
Job Description:
This position is responsible for recruiting, evaluating, and educating patients regarding clinical trials related to neuromuscular disease. This position coordinates all aspects of assigned research studies including recruitment, study visit activities according to protocol, maintenance of the investigator site file, data entry, and other various tasks.
The Clinical Research Coordinator collaborates with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. This position manages assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Monitors study participants' progress including documenting and reporting adverse events. Participates in periodic quality assurance audits of protocols.
This position will be or become familiar with neuromuscular disease and conducting research according to ICH GCP guidelines.
The position requires an individual with exceptional communication skills and the ability to multi-task to work collegially with members of the neuromuscular research team to ensure research studies are being conducted according to protocol.
Job Duties
Recruits, evaluates, and educates patients regarding clinical trials related to neuromuscular disease
Conducts Informed Consent Interview with participant and caregiver following Neuromuscular Program Standard Operating Procedures (SOP) for obtaining consent from cognitively normal and cognitively impaired individuals. Follows SOP for determination of when use of a Surrogate consent form is necessary, due to extent of cognitive impairment.
Documents trial related activities per regulatory requirements in a timely and accurate manner.
Coordinates of all aspects of study visit activities for patients and families, including scheduling of hospital-based procedures such as MRI and PET, and other procedures to include clinical study visit interviews and assessments, ECG, lab draws, IV infusions, lumbar punctures, and dispensation of study medication.
Gathers accurate medical history and concomitant medication information and ensures that medical conditions and medications meet trial specifications.
Probes patient/ caregiver for any changes in health throughout clinical trial intervention and monitors for potential adverse events. Obtains complete reports of new symptoms/changes in health conditions and reviews with clinician/principal investigator. Based on principal investigator's determination of adverse event (AE) qualification, prepares formal AE report for sponsor and for IRB, when applicable per regulations. If AE meets criteria of Serious Adverse Event (SAE), prepares full FDA MedWatch or sponsor-provided Safety Report and submits to regulatory authorities within 24 hours of learning of event.
Assists physician in cerebrospinal fluid (CSF) collection for clinical trials by educating patient / caregiver regarding the lumbar puncture procedure, preparing lumbar puncture supplies, providing supplies to physician during procedure while maintaining sterile field, aliquoting CSF by protocol-specified amounts into separate vials for storage and transport, instructing patient/caregiver in post-lumbar puncture care and expectations, conducting follow -up phone call to determine if any adverse events were experienced.
Prepares local and central lab requisition forms to ensure proper testing is conducted on CSF, blood, and urine samples.
Prepares and ships biological specimens to central labs per protocol and regulatory requirements.
Conducts interviews with patient and/or caregiver regarding mood, anxiety, neurobehavioral symptoms, and functional abilities.
Ensures all study staff completes required training for proper conduct of the trial
Ensures investigator's timely review of lab tests, EMG/ECG/MRI/PET results and communicates clinically relevant information to patient and patient's primary care doctor as appropriate.
Ensures availability of medical records, updated subject records and updated protocols.
Updates and maintains regulatory binders.
Prepares adverse event reports and protocol deviation reports for submission to IRB.
Assists the Research Institute regulatory project manager in preparation of IRB submissions, including review of consent forms, new study and continuing review applications, and protocol amendments.
Ensures all study data is entered into sponsor-provided and/or internal KU databases per sponsor requirements, typically within 3 business days following data collection.
Required Qualifications
Bachelor's degree in basic science or health related field. Experience may substitute for degree on a year for year basis.
Proficiency in computer software, systems, and programs
Attention to detail, time-management skills, strong work-ethic, self-motivated, willing to learn, good interpersonal skills. Ability to interact with multidisciplinary teams including patients, families, physicians, and administrative staff.
Ability to manage multiple tasks and set priorities and meet deadlines
Excellent written and verbal communication skills
Periodic travel to attend national meetings
Preferred Qualifications
Prior health care and/or research experience.
Familiarity with electronic medical records.
Experience in Neurology and/or Neuromuscular research.
SOCRA CCRP certification
Employee Type:
Regular
Time Type:
Full time
Rate Type:
Salary
Pay Range:
$58,000.00 - $86,000.00
Minimum
$58,000.00
Midpoint
$72,000.00
Maximum
$86,000.00
Application Instructions:
To learn more and apply online, please visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Kansas-City-Metro-Area/Clinical-Research-Coordinator_JR005056 or go to https://careers.kumc.edu/ and search for position number JR005056.
Applications must be submitted directly through the KU Medical Center website to be considered for this position. Any applications submitted via email or this website will NOT be reviewed or considered.
About KU Medical Center:
The University of Kansas Medical Centers mission is to educate exceptional health care professionals through a full range of undergraduate, graduate, professional, postdoctoral and continuing education programs in the schools of Medicine, Nursing and Health Professions. KU Medical Center also advances the health sciences through world-class research programs; provides compassionate and state-of-the-art patient care in an academic medical center environment; and works with communities in every Kansas county to improve the health of Kansans. Learn more at www.kumc.edu .
Benefits:
KUMC offers a range of great benefits that support employees and eligible family members. Our health insurance benefits begin on hire date and KUMC offers other exciting benefits such as paid parental leave, generous employer retirement contributions and other resources to improve health and well-being. For more information, please visit https://www.kumc.edu/human-resources/benefits.html
Can you also include the following EEO statement on all of our advertising locations: KU is an EO/AAE. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, genetic information or protected Veteran status. http://policy.ku.edu/IOA/nondiscrimination
jeid-7b511d0968efdb4386f6871a35ce580e
Please Note :
epokagency.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, epokagency.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.