Clinical Data Coordinator II

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

SUMMARY:

Primary functions include assisting project managers with the management of clinical trial data including export and reconciliation of data from the EXCELSIOR™ cloud application environment, 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. 

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

• Understand the EXCELSIOR™ product, protocol and conduct of ophthalmic clinical trials in sufficient detail to be able to adequately discuss and manage tasks with project managers and team members
• Comply fully with Merit policies and Standard Operating Procedures (SOPs)
• Update and improve DM tools in response to Excelsior software/study configuration changes
• Perform data management functions
• Develop, review, and approve Data Transfer/Import Agreements
• Participate in meetings and conference calls with sponsor or CRO 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 Sponsor or CRO
• Provide feedback to Sponsor or CRO during data reconciliation
• Perform data quality control functions
• Implement project specific data review plan
• 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

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

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.