Project Coordinator I (US Remote)

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 Project Coordinator to work Monday thru Friday from 5:00 AM ET to 1:00 PM ET under direct supervision, assists the Project Management Division with the coordination and conduct of project management activities, including the creation and distribution of study-related documents. Carries out management directives in a professional, efficient, and thorough manner. Primary functions include supporting the management of clinical trial data in the EXCELSIOR™ cloud application environment; performing data upload, and quality control functions; recording and distributing meeting minutes, maintenance of controlled documents including Master Project Files; and providing support functions for clinical sites, reading centers, and clients according to company and/or study-specific procedures and Good Clinical Practices (GCP).

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

Administrative Duties:

• Assist in the management of office tasks, including organization and coordination of controlled documents
• Assist with all aspects of study management 
• Assist in the development of the project and regulatory documents; includes proofreading of documents
• Assist in the creation, duplication, and dissemination of documents.
• Assist with responses to quality review audits
• Monitor own work to ensure quality and completeness

Study-Related Duties:

• Assist with all study activities from start-up through close out
• Organize and prioritize work assignments to complete assignments and tasks on time, with quality, and has the ability to anticipate problem areas in advance.
• Apply creative approaches and ideas to solve problems maximizing the effective use of appropriate resources.
• Initiation of Master Project File and maintenance of project documents
• Generate and email eligibility notifications 
• Attend project meetings internally and with the sponsor (via teleconference or face-to-face) throughout the project
• Communicate with Shipping and Receiving Department to confirm shipment and receipt of study-related materials at the designated address.

Software-related Duties:

• Understand the EXCELSIOR™ product, protocol, and conduct of clinical trials in sufficient detail to be able to adequately discuss tasks with study team members
• Assist with the review of EXCELSIOR™ study-specific configuration
• Manage and review site surveys; update EXCELSIOR™ for site registration
• Assist with providing guidance and training to sponsors, CROs, clinical sites, and graders on the use of EXCELSIOR™, including software functionality and technical support
• Image check-in and quality control
• Issue and review data query responses to ensure completeness and accuracy of response relative to other data
• Review, categorize, and respond to customer support and complaint tickets in the helpdesk application
• Perform and document periodic review of inactive users in EXCELSIOR

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.

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

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:

Preferred bachelor’s degree in a health-related, biological science, computer science, data entry, customer service, or business management field (or internal company work experience). 

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.

The noise level in the work environment is usually quiet to moderate

 Benefits Offered: 

• 401k Retirement 
• Health Insurance
• Paid Holiday 
• Paid Long-Term Disability insurance
• Paid Life Insurance
• Paid Time Off

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.