Job description

Title: Clinical Research Technician

Location: Overland Park, KS

Duration: 6 Months

Shift times: 8 hour days between 7am-7pm with hours flexing based upon study needs to cover all US time zones and working schedules of our volunteers.

PURPOSE: Perform a variety of clinical procedures to collect, record, report and interpret data on volunteers enrolled and/or seeking enrollment in clinical studies according to standard operating procedures (SOPs). Monitor volunteer response to evaluate effect of investigational device. Assist with daily workload planning.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• - Working knowledge of Phase I clinical trials
• - Working knowledge of the principles of Good Clinical Practices (GCP)
• - In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
• - Good skill in using MS Windows and Office applications such as Access, Outlook and Word
• - Excellent interpersonal skills
• - Ability to pay close attention to detail
• - Ability to establish and maintain effective working relationships with coworkers, managers and clients

RESPONSIBILITIES:

• Incumbents in this job classification may work in the clinic, screening, recruitment or any other department into which they have cross trained and may be expected to perform duties not specified below. They may also specialize aspects of this job such as training, staffing or study coordination, and may not be required to carry out all responsibilities indicated below.
• Collaborate with the Study Director/Coordinator to prepare for and execute assigned studies. Assist in ensuring that study objectives are met on time, within budget and according to applicable regulations and quality standards.
• - Review of study protocols, case report forms (CRF), other study documents, and electronic data capture systems;
• - Feedback on clinical strategy and concerns;
• - Clinical set-up and preparation of the study including setting up equipment and documents;
• - Planning logistical activity for procedures as per protocol;
• - Generate materials, documents, and records;
• - Attend or delegate all relevant study meetings including those with clients;
• - Troubleshoot issues on study;
• - Participate in huddles to ensure daily tasks are assigned to team members and are executed to the expected standards;
• - Assist with data quality checking and query resolution.
• - Orient volunteers to the study and the unit including the purpose of the study, procedures, and protocol issues such as timelines for visits and restrictions on food and drink
• - Collect, record and maintain volunteer study data according to study-specific protocol and SOPs ensuring quality control for content, accuracy and completeness.
• - Perform a variety of complex clinical procedures that may include but not be limited to ECG, sample collection, spirometry, vital signs, cannulation and cardiac telemetry monitoring. Record, report and interpret findings appropriately to develop study-specific database.
• - Monitor volunteer safety and report adverse reactions to appropriate medical personnel. Attend to volunteer needs and requirements
• - Maintain and restock medical supplies as needed. Maintain cleanliness and sanitation of the unit.
• - Provide training to new staff members on study-specific topics and new clinical skills. Assist in ensuring compliance with staff training requirements by auditing and maintaining training records. Contribute to development of employees' training plans by advising Team Leads of continuing education requirements and opportunities.
• - Recruit and screen volunteers for trials and maintain volunteer database.
• - Participate in quality and process improvement efforts to support the culture towards a high-performing and efficient team.
• - Assist with planning related to staffing and scheduling. Assist in ensuring that work shifts are staffed as required by sourcing internal staff, booking bank or PRN staff, updating the scheduling system, and notifying staff of assignments.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• - Bachelors degree or educational equivalent; or High school diploma and 2-4 years relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training and experience
• - Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies

PHYSICAL REQUIREMENTS:

• - Use of telephone and face-to-face communication requiring accurate perception of speech
• - Use of keyboard requiring repetitive motion of fingers
• - Frequent mobilization around the facility
• - Occasional lifting and moving objects weighing up to 10 lbs/4.5 kg

Job Type: Contract

Salary: $19.00 - $21.00 per hour

Schedule:

• Day shift

Ability to commute/relocate:

• Overland Park, KS: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Clinical trials: 1 year (Preferred)
• phase 1: 1 year (Preferred)

Work Location: One location

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