Reports to: Clinical Research Site Supervisor
Directly Supervises: This position does not have direct reports
Applicants who are certified though ACRP will be considered before those applicants that are not. We are looking for applicants with unparalleled work ethic and a "whatever-it-takes" determination. This position is not eligible for relocation expenses. Applicants may be asked to take a test to measure their skills as a Clinical Research Coordinator.
Expectation for all employees: To support the organization’s passionate cause, vision, and FUNdamentals by exhibiting the following behaviors: excellence and competence, collaboration, innovation, respect, accountability, and ownership. Employees are expected to be professional and collaborative.
Position Purpose: The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of the Clinical Research Site Supervisor 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 judgement, and a high level of knowledge of study-specific protocols.
- Develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials
- Provide results-oriented administration of operational activities to ensure quality and efficient services are provided
- Facilitate professional, efficient service to patients and the clinical trial industry
- Coordinate telephone and email communications
- Input and process documentation regularly and accurately
- Coordinate professional relationships with physicians, vendors, and industry representatives
- Oversee patient enrollment and randomization for clinical trials and completion of required documentation
- Ensure quality assurance (QA) and data integrity
- Provide Sponsor, CRO and other industry representatives with usable data by converting patient’s source documentation into Case Report Forms (CRFs)
- Coordinate and resolve all queries and problems associated with data submissions
- Thoroughly prepare for all Sponsor, CRO, and FDA visits, including PSVs, SIVs, IMVs, COVs, and audits of all types
- Serve as the point of contact for all stages of a clinical trial from pre-study through closeout
- Display basic understanding of GCP/ICH Guidelines
- Participate in the On-Call schedule
- Perform local recruiting efforts for clinical trials
- Solicit industry-sponsored trials through contacts and professional organizations
- Direct the requisition, collection, labeling, storage, and/or shipment of specimens
- Perform specific protocol such as interviewing patients, taking vital signs, and blood draws
- Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics
- Oversee patient enrollment to ensure that informed consent is obtained & documented
- Perform internal monitoring duties on other CRC charts in order to reduce the number of data queries and issues
- Assist the Clinical Research Administrative Specialists in correcting errors in source documents and CRFs
- Serve as a resource to other CRCs and demonstrate abilities as a subject matter expert (SME)
- Other duties and responsibilities as assigned
Minimum Position Requirements:
- 2 years of clinical research experience
- CRC Certification with ACRP
Education: Appropriate education and/or experience may be substituted on equivalent basis
Knowledge, Skills, & Abilities:
Demonstrated excellence in performing the duties of the Clinical Research Coordinator position according to company expectations and objectives. Ability to maintain professionalism and professional standards. Must have a sense of urgency. Set priorities. Identify and resolve problems effectively and efficiently. Excellent communication and organizational skills for managing workflow and follow-up. Ability to demonstrate reliability and maintain confidentiality. Possess temperament and emotional intelligence for dealing with others professionally. Must have a “do-what-it-takes” attitude. Excellent speaking skills to communicate clearly and effectively with patients, physicians, industry professionals, and others in person or over the phone.
Background and criminal history check
Others as needed
Manual Dexterity: Work requires moderate speed and accuracy, excellent keyboarding skill for computer use.
Physical Effort: Work requires considerable variety of fairly steady active physical exertion. Some and/or continuous standing or walking. Some lifting of items less than 20 lbs.
Working Conditions: Potential for early morning and/or late-night responsibility, occasional 24-hour on-call duty
Hazards: Potential exposure to blood and body fluid exposures.
Travel: Travel is not a regular expectation of this position
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
A description of IACT Health
IACT Health is a dedicated, wholly owned clinical research trial company staffed entirely by specialists. Our specialist range from patient coordinator specialists to regulatory specialists. Across the Southeast our staff applies the highest level of dedication and expertise to conduct studies in Pharmaceutical, Biotech and Medical Devices. We go above and beyond to provide highest quality care for patients and to guarantee optimal results for CROs, sponsors and physicians.
By making our physician scientists successful, improving trial success rates, and increasing efficiency in the cost of research, we are helping to accelerate medical innovations that improve people’s daily lives.
Our very name reflects our mission. For patients, it is our promise of active, genuine personal concern. For physicians, it is a commitment to a partnership that improves patient care and clinical success. For CROs and sponsors, IACT represents a guarantee of reliability, mastery, and the infrastructure necessary to exceed patient recruitment and quality data requirements.
Company Website: www.iacthealth.com
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