Clinical Research Coordinator

Department:
SOM KC The Alzheimer's Disease Center (ADC)

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Clinical Trials Unit
Position Title:
Clinical Research Coordinator
Job Family Group:
Professional Staff
Job Description Summary:
The University of Kansas Alzheimer’s Disease Center (KUADC), located at the University of Kansas Medical Center, is a National Institute of Aging P30-designated national leader in AD research with the vision to impact the lives of every patient and family dealing with Alzheimer’s in the region and across the state of Kansas through our research, education, and clinical care with the goal of finding a cure. We are a comprehensive center at the forefront of clinical trials, lifestyle intervention trials, drug and translational research and basic science research. In addition, we provide a wide variety of both public education and training opportunities for the workforce of tomorrow. Our research enables us to also provide leading edge clinical care and support for dementia caregivers.
This position works with multidisciplinary teams including patients/study participants, families, physicians, and administrative staff to coordinate all aspects of clinical trial activities for trials within the Alzheimer’s Disease Center. Through careful and well-planned methods, this position ensures that study procedures follow the sponsor’s protocol and all applicable regulatory requirements while also ensuring research participants and their families are treated with the utmost respect and concern for their well-being and safety.
Job Description:

Job Duties

• Recruit, evaluate, and educate patients regarding clinical trials related to Alzheimer’s Disease.
• Conduct Informed Consent Interview with participant and caregiver following ADC Standard Operating Procedures (SOP) for obtaining consent from cognitively normal and cognitively impaired individuals. Follow SOP for determination of when to use of a Surrogate consent form is necessary, due to extent of cognitive impairment.
• Document trial-related activities per regulatory requirements in a timely and accurate manner.
• Coordinate 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.
• Gather accurate medical history and concomitant medication information and ensure that medical conditions and medications meet trial specifications.
• Probe patient/caregiver for any changes in health throughout clinical trial intervention and monitors for potential adverse events. Obtain complete reports of new symptoms/changes in health conditions and review with clinician/principal investigator. Based on principal investigator’s determination of adverse event (AE) qualification, prepare formal AE report for sponsor and for IRB, when applicable per regulations. If AE meets criteria of Serious Adverse Event (SAE), prepare full FDA MedWatch or sponsor-provided Safety Report and submit to regulatory authorities within 24 hours of learning of event.
• Assist 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, instruct patient/caregiver in post-lumbar puncture care and expectations, conduct follow –up phone call to determine if any adverse events were experienced.
• Prepare local and central lab requisition forms to ensure proper testing is conducted on CSF, blood, and urine samples.
• Prepare and ship biological specimens to central labs per protocol and regulatory requirements.
• Conduct interviews with patient and/or caregiver regarding mood, anxiety, neurobehavioral symptoms, and functional abilities.
• Ensure all study staff completes required training for proper conduct of the trial.
• Ensure investigator’s timely review of lab tests, ECG/MRI/PET results and communicates clinically relevant information to patient and patient’s primary care doctor as appropriate.
• Ensure availability of medical records, updated subject records and updated protocols.
• Update and maintain regulatory binders.
• Prepare adverse event reports and protocol deviation reports for submission to IRB and to study sponsor.
• Collaborate with 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.
• Ensure all study data is entered into sponsor-provided and/or internal KU databases per sponsor requirements, typically within 3 business days following data collection.
• Other duties as assigned by supervisor.

Required Qualifications

• Bachelor’s degree in basic science or health related field. Experience may substitute for degree on a year for year basis.
• Computer skills: MS Office Suite.
• Attention to detail, time-management skills, strong work-ethic, self-motivated, willing to learn, excellent interpersonal skills

Preferred Qualifications

• CCRP certification through Society of Clinical Research Associates (SoCRA) or CCRC certification through Academy of Clinical Research Professionals (ACRP).
• Prior health care and/or research experience.
• Excellent communication, writing, organizational and presentation skills.
• Ability to effectively interact with multidisciplinary teams including patients, families, physicians, and administrative staff.
• Familiarity with electronic medical records and study databases.

Required Documents

• Resume
• Cover Letter

Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A11
Pay Range:

Minimum

51348

Midpoint

65352

Maximum

79356

Department:
SOM KC The Alzheimer's Disease Center (ADC)

-----

Clinical Trials Unit
Position Title:
Clinical Research Coordinator
Job Family Group:
Professional Staff
Job Description Summary:
The University of Kansas Alzheimer’s Disease Center (KUADC), located at the University of Kansas Medical Center, is a National Institute of Aging P30-designated national leader in AD research with the vision to impact the lives of every patient and family dealing with Alzheimer’s in the region and across the state of Kansas through our research, education, and clinical care with the goal of finding a cure. We are a comprehensive center at the forefront of clinical trials, lifestyle intervention trials, drug and translational research and basic science research. In addition, we provide a wide variety of both public education and training opportunities for the workforce of tomorrow. Our research enables us to also provide leading edge clinical care and support for dementia caregivers.
This position works with multidisciplinary teams including patients/study participants, families, physicians, and administrative staff to coordinate all aspects of clinical trial activities for trials within the Alzheimer’s Disease Center. Through careful and well-planned methods, this position ensures that study procedures follow the sponsor’s protocol and all applicable regulatory requirements while also ensuring research participants and their families are treated with the utmost respect and concern for their well-being and safety.
Job Description:

Job Duties

• Recruit, evaluate, and educate patients regarding clinical trials related to Alzheimer’s Disease.
• Conduct Informed Consent Interview with participant and caregiver following ADC Standard Operating Procedures (SOP) for obtaining consent from cognitively normal and cognitively impaired individuals. Follow SOP for determination of when to use of a Surrogate consent form is necessary, due to extent of cognitive impairment.
• Document trial-related activities per regulatory requirements in a timely and accurate manner.
• Coordinate 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.
• Gather accurate medical history and concomitant medication information and ensure that medical conditions and medications meet trial specifications.
• Probe patient/caregiver for any changes in health throughout clinical trial intervention and monitors for potential adverse events. Obtain complete reports of new symptoms/changes in health conditions and review with clinician/principal investigator. Based on principal investigator’s determination of adverse event (AE) qualification, prepare formal AE report for sponsor and for IRB, when applicable per regulations. If AE meets criteria of Serious Adverse Event (SAE), prepare full FDA MedWatch or sponsor-provided Safety Report and submit to regulatory authorities within 24 hours of learning of event.
• Assist 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, instruct patient/caregiver in post-lumbar puncture care and expectations, conduct follow –up phone call to determine if any adverse events were experienced.
• Prepare local and central lab requisition forms to ensure proper testing is conducted on CSF, blood, and urine samples.
• Prepare and ship biological specimens to central labs per protocol and regulatory requirements.
• Conduct interviews with patient and/or caregiver regarding mood, anxiety, neurobehavioral symptoms, and functional abilities.
• Ensure all study staff completes required training for proper conduct of the trial.
• Ensure investigator’s timely review of lab tests, ECG/MRI/PET results and communicates clinically relevant information to patient and patient’s primary care doctor as appropriate.
• Ensure availability of medical records, updated subject records and updated protocols.
• Update and maintain regulatory binders.
• Prepare adverse event reports and protocol deviation reports for submission to IRB and to study sponsor.
• Collaborate with 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.
• Ensure all study data is entered into sponsor-provided and/or internal KU databases per sponsor requirements, typically within 3 business days following data collection.
• Other duties as assigned by supervisor.

Required Qualifications

• Bachelor’s degree in basic science or health related field. Experience may substitute for degree on a year for year basis.
• Computer skills: MS Office Suite.
• Attention to detail, time-management skills, strong work-ethic, self-motivated, willing to learn, excellent interpersonal skills

Preferred Qualifications

• CCRP certification through Society of Clinical Research Associates (SoCRA) or CCRC certification through Academy of Clinical Research Professionals (ACRP).
• Prior health care and/or research experience.
• Excellent communication, writing, organizational and presentation skills.
• Ability to effectively interact with multidisciplinary teams including patients, families, physicians, and administrative staff.
• Familiarity with electronic medical records and study databases.

Required Documents

• Resume
• Cover Letter

Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A11
Pay Range:

Minimum

51348

Midpoint

65352

Maximum

79356