Clinical Research Coordinator
Job Title: Clinical Research Coordinator - RN
Department: Clinical Research
Overtime Status: Exempt
Position reports to: Clinical Manager of Research
Location of position: Wichita, KS
Position Summary:
The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of the Clinical Research Manager and the Principal Investigator. The CRC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CRC will perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study specific protocols.
Responsibilities:
- Coordinates with the Principal Investigator to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsor established policies and procedures.
- Assists the PI to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Documents date of training and signatures of study personnel trained on study specific training log.
- Completes all protocol specific training (IATA, GCP, Protocol, EDC, IWRS, etc.)
- Coordinates and facilitates monitoring and auditing visits. Notifies Clinical research manager and PI of external audits by FDA and sponsors.
- Prepares documents for review by sponsors, monitors and regulatory authorities, as necessary
- Participates in meetings with sponsors, monitors and regulatory authorities, as necessary.
- Collaborates with PI and clinical research manager to respond to audit findings and implement approved recommendations.
- Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
- Collaborates with the Clinical research manager and administrator to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.
- Assists the PI in study feasibility assessments and confidentiality agreements as requested.
- Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
- Attends site selection meetings, site initiation visits, and investigator meetings as required or requested by the PI.
- Reviews and comprehends the protocol.
- Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
- Maintains study timelines by appropriately scheduling patients as outline in protocol
- Collaborates with the PI to prepare IRB and any other regulatory submission documents to include protocol signature pages, protocol amendments, informed consent amendments, etc.
- Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
- Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study.
- Ensure written informed consent is obtained prior to participation in the study according to GCP and FDA guidelines.
- Identify and promptly reports protocol deviations, AEs, and SAEs in accordance to protocol, IRB, and/or sponsor requirements
- Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
- Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
- Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document; case report forms (CRFs), enrollment logs, and drug/device accountability logs.
- Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
- Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
- Schedules and Interprets participant scans and procedures with outside contracted facilities.
- Creates source documents and collects data as required by the protocol. Assures timely completion of Case Report Forms.
- Dispenses IP and drug accountability (Accurately registering in IWRS and EDC receipt and dispensing or IP. Maintaining and accurately updating medication logs)
- Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Wichita Urology Group Policy on Investigational Drug/Device Accountability.
- Performs EKG, performs and interprets vital signs, obtains relevant laboratory specimens, and assists with physical exams, assessments, and procedures.
- Completes study documentation and maintains study files in accordance with sponsor requirements (e.g., consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms).
- Monitors and records temperature readings
- Retains all study records in accordance with sponsor requirements and procedures.
- Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable federal agencies and sponsor in accordance with federal regulations and sponsoring agency policies and procedures.
- Arranges secure storage of study documents that will be maintained according to university policy or for the contracted length of time, whichever is longer.
Required Qualifications:
- Graduate of an accredited RN Program
- Current Licensure by the Kansas State Board of Nursing
- Maintenance of Continuing Education hours in accordance to Kansas State Board of Nursing requirements
- Clinical Research coordinator experience preferred
- Certified Clinical Research Coordinator (CCRC) Designation Preferred
- Strong interpersonal skills with ability to organize, multi-task and prioritize details
- Ability to work well in team environment
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Average, ordinary, visual acuity necessary to prepare or inspect documents or products, or operate machinery.
- Prolonged periods of sitting, standing or walking may be required, should be able to transport approximately 0-25lbs of charts or files.
- Occasional assistance in patient transfers of up to 50lbs.
Working Conditions:
- While performing the duties of this job, the employee is frequently exposed to blood, body fluids, fumes, or airborne particles, and sharp objects potentially contaminated with blood borne pathogens or other infectious agents.
Wichita Urology Group provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, gender identity or genetics. In addition to federal law requirements, Wichita Urology Group complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Wichita Urology Group expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wichita Urology Group’s employees to perform their job duties may result in discipline up to and including discharge.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Employee discount
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
Ability to Commute:
- Wichita, KS 67226 (Required)
Ability to Relocate:
- Wichita, KS 67226: Relocate before starting work (Required)
Work Location: In person
