MERIT 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 Respiratory Therapist that will accurately and competently administers activities regarding oversight and review of spirometry and pulmonary function tests conducted by study site personnel. Responsible for preparing training materials and conducting training sessions for sites, subjects and Company personnel for spirometry and pulmonary function testing 

ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.)

• Reviews spirometry and pulmonary function tests submitted with training documentation for appropriate and adequate data and technique.
• Reviews spirometry and pulmonary function tests submitted by clinical trial sites during the conduct of a clinical trial as outlined by sponsor requests or requirements.
• Assists with development of training sessions and materials for members of the team, and compliance with SOPs.
• Prepares educational material and training documentation for conducting and collecting spirometry and pulmonary function test data.
• Assists in conducting training sessions via teleconference, computer-based training, or on-site training to clinical study sites, sponsors, and/or MERIT staff for collecting and reviewing spirometry and pulmonary function test data. 
• Understands and demonstrates proficiency in the use of and navigation of MERIT customized software for study data collection and review.
• Drafts and reviews study-specific documents such as procedure manuals, configuration documents, study plans, and data transfer agreements. 
• Reviews data submitted from sites for quality and accuracy. 
• Generates and issues queries and requests for Data Clarification Forms (DCFs) to sites.
• Assists in training external non-clinical trial site team members and MERIT staff .
• Provides professional presentations and contributions to any corporate contact during off-site interactions.
• Prepares materials and presents at virtual or on-site capability meetings and study kick-off meetings. 
• Prepares and presents at Investigator meetings, site and sponsor training sessions, and site initiation visits. 
• Attends study-related meetings to discuss processes, study procedures, and data received from clinical sites. 
• Practices and responds with commitment and sensitivity toward satisfying the needs of internal and external customers. 
• Promotes quality and continuous improvement philosophy.
• Evaluates situations objectively and demonstrates the ability to make timely decisions intended to have a positive effect on work performance.
• Organizes and prioritizes work assignments to complete assignments and tasks on time, with quality and has the ability to anticipate problem areas in advance. Applies creative approaches and ideas to solve problems maximizing effective use of appropriate resources.
• Understands and implements Good Clinical Documentation Practice 
• Provides assistance to the Quality Assurance department in review of spirometry and pulmonary function data. 
• Demonstrates flexibility in approach and ideas, responds positively and supports changes in procedures, process, technology, responsibility and assignments.
• Maintains cooperative and productive working relationships and communications with all employees, participating effectively as a team member or as a team leader. Encourages and assists others in self-improvement.
• Develops and maintains a positive company image and positive relations between MERIT and sponsors, vendors, CROs, study monitors (CRAs) and sites.
• Demonstrates a commitment to maintain safe, clean and orderly work area. Promotes and follows safety regulations and actively contributes to work safely.
• Performs other duties as assigned.

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:

BA or BS degree in business, nursing or related field from a four-year college or university. 

A minimum of two (2) years related experience and/or training in reviewing spirometry and pulmonary function tests, preferably in a health care or service-related environment, or equivalent combination of education and experience. Supervisory and/or management experience preferred.

Other Skills and Abilities:

Strong interpersonal and organizational skills, excellent attention to detail, ability to follow direction, 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 read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. 

Ability to participate and contribute in a team environment as a team member or in a leadership role. Oral and written communication is clear, concise, and effective. Ability to maintain neutral approach when resolving conflicts and utilize the Human Resources area as a resource. 

This position requires a flexible work schedule with occasional on-call availability to meet the demands of ongoing clinical trials. While core working hours will be established, there may be times when weekend or after-hours work is necessary to ensure the smooth execution and timely completion of studies.

Ability to travel, domestic and international, up to 10%

Licenses or Certifications Required: 

Two- or four-year AMA approved Respiratory Therapy Program or completion of requirements to become registered by the National Board of Respiratory Care. 

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 is frequently required to stand; walk and sit. The employee is occasionally required to reach with hands and arms, stoop, crouch, kneel and climb. The employee must frequently 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), Dental insurance, Disability insurance, Health insurance, 8 Holiday Pay, Life insurance, Paid time off

and 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 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 MERIT.