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Johnson County Clin Trials (JCCT) · 11 hours ago

Assistant Study Coordinator

Lenexa, KS

Full-time

Onsite

New Grad, Entry Level

Johnson County Clin Trials (JCCT) is seeking an Assistant Study Coordinator to provide administrative support to the Study Coordinators. The role involves assisting in executing clinical study activities, preparing trial-related documents, and ensuring compliance with study protocols and regulations.

BiotechnologyClinical TrialsConsultingLife ScienceMedicalTherapeutics

Responsibilities

Ensure the confidentiality of clinical research volunteers and sponsors

Maintain and advocate a high level of customer service and quality within the department

Assist in the maintenance of Clinical Conductor

Maintain the ERP system including preparing, filing, assisting with updates and archiving study related information

Prepare, handle, distribute, track and maintain clinical trial related supplies

Assist with educating study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements

Assist in tracking volunteer visits in Clinical Conductor, rescheduling as needed and update study coordinators in a timely fashion regarding missed visits or compliance issues

Perform protocol specific activities including but not limited to medical history, vital signs, electrocardiograms and specimen collection

Record adverse events and concomitant medication use and follow-up on open adverse events until through resolution

Obtain and document study related events and data in compliance with GCP/SOPs

Communicate necessary volunteer information in a timely manner to study coordinator/PI on an ongoing basis

Assure source documents/charts are prepared for future study visits

Proactively communicate issues and or problems to the Senior Study Coordinator

Other duties as assigned

Qualification

Clinical trial managementGCP complianceMedical terminologyMicrosoft Office SuiteData entry skillsAnalytical skillsCommunication skillsInterpersonal skillsProblem-solving skillsOrganizational skillsTime managementDetail orientedSelf motivated

Required

Excellent communication, interpersonal, analytical and problem-solving skills

Microsoft Office Suite proficiency

Writing and verbal communication skills

Knowledge of medical terminology and concepts

Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc

Strong study documentation skills in compliance with ALCOA+

Proficient typing and data entry skills

Ability to work effectively with a team

Ability to manage small projects personally and work independently

Memory to retain information and know where to research answers

Time management skills

Organizational skills

Detail oriented with the ability to perform at a high level of accuracy

Demonstrates strong analytical, problem solving skills

Self motivated

Must be results oriented, multi-tasking, quick learner

Respond to the urgent needs of the team and show a strong track record of meeting deadlines

Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel

Ability to lift and/or move up to 20 pounds

High school diploma or GED is required

Preferred

Bachelor's degree is preferred

Experience in a clinical research setting or related work environment is preferred

Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)

Familiarity with or ability to learn clinical trial management system software

Company

Johnson County Clin Trials (JCCT)

Johnson County Clin-Trials (JCCT) has been providing clinical research services to small biotech’s and large multi-national CRO’s and Pharma since 2005.

Founded in 2005