Respiratory Project Manager I at MERIT CRO Inc

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

This position supports the execution of respiratory-focused clinical trials under the guidance of the Senior Project Manager. This entry-level role provides exposure to all phases of trial management—study start-up through closeout—while also contributing to data management activities such as spirometry and pulmonary function test (PFT) review, EXCELSIOR™ configuration, and quality control checks.

This position is designed to develop foundational project management skills in a CRO environment, while supporting the accuracy and integrity of respiratory data collection in compliance with study protocols, Good Clinical Practices (GCP), and MERIT procedures.

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

Project and Study Support:

• Assist with study start-up activities, including preparation of study materials, organization of kick-off meetings, and documentation.
• Support routine communication with sponsors, sites, and internal teams, escalating issues to the Senior PM as appropriate.
• Contribute to the development and maintenance of study-specific documentation, including Master Project Files, site lists, and correspondence logs.
• Generate and distribute status reports, eligibility reports, and study notifications.
• Attend sponsor, investigator, and internal meetings to gain experience in study oversight.
• Establish study files and create and distribute study documents
• Organize and prioritize work assignments to ensure tasks are completed on time and with quality, applying creative approaches to problem-solving.

Data and Quality Management:

• Perform initial reviews of spirometry and PFT data submitted by sites to ensure compliance with study documentation.
• Assist with data queries, clarifications, and issue resolution in collaboration with Respiratory therapist and the Senior PM.
• Conduct quality control checks of clinical data to support audit readiness and data integrity.
• Document findings clearly and contribute to corrective action processes.
• Support established study-specific systems and procedures for regular status updates, site information lists, and document revisions.
• Generate study reports and updates to keep stakeholders informed.
• Assist with processing clinical data from study start-up through database lock.

Software-related Duties:

• Gain working knowledge of the EXCELSIOR™ platform, study protocols, and clinical trial conduct sufficient to support assigned tasks.
• Assist with configuration of studies within EXCELSIOR™, including reviews, user acceptance testing, and study-specific documentation.
• Provide guidance and training to sponsors, CROs and clinical sites on the use of EXCELSIOR™, including software functionality and technical support
• Ensure accurate and efficient set up of EXCELSIOR™ for assigned project(s) through reviews, user acceptance testing, and study specific charter review and development
• Assist with site setup in EXCELSIOR™, including technician and equipment registration.
• Assist with the review of EXCELSIOR™ study specific configuration
• Manage and review site surveys; update EXCELSIOR™ for site registration, clinical site technician, and equipment certification
• Help monitor user access, respond to support tickets, and escalate technical issues when appropriate.
• Follow up with sites, sponsors, and reading center personnel on EXCELSIOR access; review inactive user reports

Other:

• Comply fully with company policies and Standard Operating Procedures (SOPs)
• Participate in professional development to build knowledge of respiratory testing, project management, and GCP compliance.
• Other responsibilities may be assigned as required
• Ability to work with limited supervision
• Ability to travel up 5%

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.
• Demonstrates a commitment to maintain safe, clean, and orderly work area. Promotes and follows safety regulations and actively contributes to work safety.

Requirements

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 a bachelor’s degree in a health related, biological science, computer science, data entry, customer service or business management is preferred, or a equivalent combination of education, training, and work experience. 

A minimum of two (2) years of clinical trial or project management experience in a related field.

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 participate and contribute in a team environment as a team member. Oral and written communication is clear, concise, and effective. 

Licenses or Certifications Required: 

None.

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

Life insurance

Paid time off

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.