Clinical Data Coordinator II

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

Primary functions include assisting project managers with the management of clinical trial data, developing data transfer/import agreement (DTA) document, implementing and verifying DTA with R programming language, performing data exports to study sponsors and other contract research organizations (CRO’s) using EXCELSIOR™ according to Merit and/or study specific procedures and Good Clinical Practices (GCP), implementing data review plans, and performing functions related to software validation and IT support where relevant to data management (DM) functions

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

• Comply fully with Merit policies and Standard Operating Procedures (SOPs)
• Understand the EXCELSIOR™ product, protocol and conduct of clinical trials in sufficient detail to be able to adequately discuss and manage tasks with project managers and DM team members
• Update and improve DM tools in response to Excelsior software/study configuration changes
• Use R programming language to perform essential functions in data management, data transfer quality control, validation/verification, and other areas needed
• Perform data management functions
  • Develop, review, and approve DTA
  • Participate in meetings and conference calls with sponsors or CROs to develop transfer requirements
  • Plan and manage data transfer verification/validation activities
  • Maintain ongoing data export based on project-specific schedules and provide data transfer on time to sponsors and CROs
  • Provide inventory reports as necessary
  • Run additional custom reports as dictated by study needs
• Support data reconciliation
  • Work with project managers to review data reconciliation reports from Sponsors or CROs
  • Provide feedback to Sponsors or CROs during data reconciliation
• Perform data transfer quality control functions
  • Implement and perform data transfer file consistency and integrity check
  • Implement project specific data review
  • Establish and maintain project-specific data review schedule
  • Implement reader monitoring plan as necessary
  • Develop library of tools for data review
  • Develop library of tools for reading quality control
• Software Validation
  • Assist with writing of user requirements specific to data export functions
  • Provide user acceptance testing support for export functions and other areas as necessary
• Other responsibilities may be assigned as required

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 any of the following: biological science, mathematics and statistics, computer science, or business management.

Minimum three (3) years of work experience which may include post-graduate study in biological science, computer science, or mathematics and statistics, routinely utilizing SAS or R programming.

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:

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.