Clinical Research Coordinator

Department:
SOM KC Neurology - Neuromuscular

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Neurology
Position Title:
Clinical Research Coordinator
Job Family Group:
Professional Staff
Job Description Summary:
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 Neuromuscular's Disease Program. 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:
Required Qualifications:

• Bachelor's degree in basic science or health related field. Experience may substitute for degree on a year for year basis. CCRP certification required upon employment or one year after entry into position. Computer skills: MS Office Suite. Attention to detail, time-management skills, strong work-ethic, self-motivated, willing to learn, good interpersonal skills

Preferred Qualifications:

• Prior health care and/or research experience. Excellent communication, writing, organizational and presentation skills; ability to interact with multidisciplinary teams including patients, families, physicians, and administrative staff. Familiarity with electronic medical records.

Job Duties Outlined:

• Recruits, evaluates, and educates patients regarding clinical trials related to Neuromuscular Diseases.
  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 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.
  Performs other duties as assigned by direct supervisor.
  

Required Documents:

• Resume/CV

• 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 Neurology - Neuromuscular

-----

Neurology
Position Title:
Clinical Research Coordinator
Job Family Group:
Professional Staff
Job Description Summary:
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 Neuromuscular's Disease Program. 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:
Required Qualifications:

• Bachelor's degree in basic science or health related field. Experience may substitute for degree on a year for year basis. CCRP certification required upon employment or one year after entry into position. Computer skills: MS Office Suite. Attention to detail, time-management skills, strong work-ethic, self-motivated, willing to learn, good interpersonal skills

Preferred Qualifications:

• Prior health care and/or research experience. Excellent communication, writing, organizational and presentation skills; ability to interact with multidisciplinary teams including patients, families, physicians, and administrative staff. Familiarity with electronic medical records.

Job Duties Outlined:

• Recruits, evaluates, and educates patients regarding clinical trials related to Neuromuscular Diseases.
  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 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.
  Performs other duties as assigned by direct supervisor.
  

Required Documents:

• Resume/CV

• Cover Letter

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

Minimum

51348

Midpoint

65352

Maximum

79356