Project Coordinator I (US Remote)

MERIT CRO, Inc.•Madison, WI

3h•Remote

About The Position

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 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).

Requirements

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

Nice To Haves

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).

Responsibilities

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
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.
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
Comply fully with company policies and Standard Operating Procedures (SOPs)
Other responsibilities may be assigned as required
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.