Job Description

Job Description

Job Description

Job Title: Electronic Data Capture (EDC) Developer

Role: 6+ month contract

Candidate must be eligible to work in the US without requiring visa sponsorship

Location: Remote

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.

Why join us?

We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.

Essential Duties and Responsibilities:

• Develop, program, validate and maintain EDC clinical trial databases in accordance with study protocols and/or source documentation. Lead post-production discussions and assist with closing functional gaps and required remediation.
• Generate and maintain all required documentation related to programming activities; ensure quality of the programming and adherence to company standards.
• Identify and recommend how to optimize CRO processes based on tool functionality.
• Assist with management of external application vendor responsibilities, integrations, and implementations.
• Proactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needs.
• Actively participate in database-related user groups, to include standard forms workgroups and process improvement workgroups.
• Assists the Biostats and Data Management teams in the development and delivery of a variety of complex data processing, reports, and dashboards.
• Provides technical guidance and leadership to less-experienced individuals regarding IT functions, EDC programming, etc.
• Communicates with cross functional groups throughout the project lifecycle. Monitors project scope. Maintain a stron understanding of departmental and company procedures.
• Maintains key vendor relationships such as EDC system vendors, etc.
• Contribute to maintenance of EDC template database.
• Identify processes that will increase productivity, quality and efficiency.
• Performs other miscellaneous related duties, as required.

Qualifications:

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.

Education and/or Experience:

• BS/BA preferred. School diploma/certificate or educational equivalent; or equivalent combination of education, training and experience.
• Experience working in CRO industry preferred.
• Working knowledge of CDMS/EDC systems and CDISC standards is a must.
• Strong working knowledge of Clinical Research procedures and guidelines, required.
• Extensive organizing and coordinating skills.
• Solid understanding of clinical drug development is preferred.

Skills and Abilities:

• Excellent organizational skills and attention to detail
• Strong written and verbal communication skills.
• Technology proficiency including Data Management Systems.
• Study documentation production and maintenance, data processing, data review.
• Knowledge of clinical research including regulatory requirement GCP/ICH Data Quality.
• Strong interpersonal skills.
• Strong computer skills, including Microsoft Office.

Language Skills:

• Ability to read, interpret, and understand documents and reports containing pertinent information relating to the clinical research protocols.
• Ability to respond effectively to all inquiries.
• Ability to write routine reports and complete clinical documentation.
• Ability to comprehend medical terminology.
• Ability to effectively communicate with physicians, nurses, other team members, and representatives from outside organizations.

Mathematical Skills:

• Ability to add, subtract, multiply, and divide using whole numbers, common fractions, and decimals.

Reasoning/Problem Solving Ability:

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, or schedule form.

Physical Demands:

While performing the duties of this job, the employee is frequently required to use hands to finger, handle, or feel; stand; and talk or hear. Employee regularly reaches with hands and arms. The employee is periodically required to lift and/or carry up to 10 pounds. Occasionally, employee stoops, bends, kneels, and crouches; and pushes/pulls filled wheeled carts. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

Work Environment:

Works in a standard office environment where the noise level is usually quiet to moderate. Employee is subject to many interruptions; pressure due to deadline requirements; and handling multiple tasks simultaneously while performing assigned duties.

Safety Requirements:

Employee is required to pay particular attention to safety practices including following all safety, environmental, and infection control guidelines, procedures and protocols including wearing appropriate safety/protective equipment.

Job Tags

Similar Jobs