Description

MERIT CRO, Inc. is a global clinical trial endpoint expert specializing in multiple therapeutic areas. We’re committed to making a difference and are seeking talented people to join our team. Collaboration and customer focus are at the core of everything we do. We value diversity and are interested in people with drive, dedication, and creative problem-solving skills. We offer flexible schedules and remote opportunities

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).

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) 
• 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.

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.

Benefits Offered:

• 401(k) Retirement Plan
• Dental insurance
• Health insurance
• Paid Life insurance & AD&D
• Paid Long-Term Disability
• Paid Time Off (Vacation and Sick)
• Paid 8 Holidays
• Vision insurance
   

MERIT CRO, Inc. is an equal opportunity employer, and we are committed to hiring a diverse and talented workforce It is the employment policy and practice of MERIT CRO, Inc. to recruit and hire qualified employees without discrimination based on race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, national origin, ancestry, citizenship status, age, mental and physical disability, pregnancy, medical condition, genetic information, political affiliation, union membership, status as a parent, marital status, military or veteran status, or other classes protected by applicable law, and to not discriminate concerning compensation and opportunities for advancement, including upgrading, promotion, and transfers. We will provide reasonable accommodation to qualified individuals throughout the application, interviewing, and employment process. If you require reasonable accommodation, please contact us.