Description
MERIT is seeking a full-time position to fluently performs the duties of the Imaging Quality Control Specialist (IQCS) I role as well as creating and conducting training for internal departments. May be asked to conduct clinical site certification activities. Primary functions include processing clinical trial data in the EXCELSIOR™ cloud application environment; performing data upload, error resolution, clinical data analysis; data quality evaluation functions according to MERIT and/or study specific procedures and Good Clinical Practices (GCP).
Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.)
Clinical Data Review Duties:
Monitor own work to ensure quality and completeness
Ability to prioritize tasks by order of importance and deadlines
Strong attention to detail including identifying and correcting errors swiftly
Ability to work with limited supervision
Initial clinical data check-in (review) and quality control per training and project-specific requirements as assigned
Issue and review data queries to ensure completeness and accuracy of response relative to other data
Assist in development of project and regulatory documents; includes proofreading of documents
Assist with the development/implementation of training programs
May serve as a Subject Matter Expert to conduct training for check-in and quality control
Study-Related Duties:
Understand the EXCELSIOR™ product, protocol and conduct of clinical trials in sufficient detail to be able to adequately discuss tasks with team members and sponsors
Organize and prioritize work assignments to complete assignments and tasks on time with quality, and have the ability to anticipate problem areas in advance
Apply creative approaches and ideas to solve problems maximizing effective use of appropriate resources
Independently process clinical data from start-up through study close out; prioritizing work to meet project timelines
Follow regulatory guidelines regarding Protected Health Information (PHI)
May conduct clinical site technician and equipment certification
Provide customer service for the EXCELSIOR™ software application related to responsibilities
Provide additional support to contracted readers as applicable
Review, categorize, and respond to customer support and complaint tickets in the helpdesk application
May be asked to author procedure manuals for external distribution
Other responsibilities may be identified as company evolves
Other:
Comply fully with company policies and Standard Operating Procedures (SOPs)
Other responsibilities may be assigned as required
The following are the essential functions of the position but are not all-inclusive.
Practices and responds with commitment and sensitivity toward satisfying the needs of internal and external customers. Promotes quality and continuous improvement philosophy.
Completes work in a timely manner. Interacts with clients and co-workers in a professional manner.
Demonstrates a commitment to maintain safe, clean and orderly work area. Promotes and follows safety regulations and actively contributes to work safety.
QUALIFICATION REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience:
Minimum of five (5) years of work experience in a hospital, research hospital, or freestanding radiology facility is required. A bachelor's degree is required. Experience as a technologist in an imaging center or Contract Research Organization (CRO) is required. Experience in clinical trial imaging is highly preferred. Experience with SPECT imaging and dosimetry is a plus.
A minimum of one (1) year of clinical, clinical trial, or data quality experience in a related field along with education may be considered.
Other Skills and Abilities:
Strong interpersonal and organizational skills, excellent attention to detail, ability to follow directions, assess Company needs and work independently. Computer skills to include proficiency in Microsoft Office software and ability to learn Company specific software. Must be able to project a professional attitude and image appropriate for the work environment.
Ability to participate and contribute in a team environment as a team member. Oral and written communication is clear, concise, and effective.
Licenses or Certifications Required:
Current certification in at least one modality (PET and/or Nuclear Medicine) from an organization such as the Nuclear Medicine Technology Certification Board (NMTCB), or the American Registry of Radiologic Technologists (ARRT), or other applicable nationally recognized certifying agency.
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.
While performing the duties of this job, the employee is regularly required to use hands; to touch, finger and grasp, handle or feel, with repetitive motions, and talk or hear. The employee must be able to utilize a computer to carry out all assigned or described job duties; type, view screen, adjust peripherals, etc. The employee is required to stand and walk and sit. The employee may be occasionally required to reach with hands and arms, stoop, crouch, kneel and climb. The employee must lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
