CTMS Designer

Summary: CTMS designer is responsible for enforcing policies and procedures for gathering and creating accurate and compliant eSource. They will be responsible for creating, execution and managing eSource at multiple site locations. They will also be responsible for coordinating with the data management team for eSource creation, execution, and management. This position will also be responsible for providing insight into the development of eSource processes and SOPs, while contributing to strategic decisions affecting their functional responsibilities. They will also be responsible for meeting site/sponsor/vendor data eSource requirements and ensure eSource compliance with GCP/ICH and FDA requirements. The ideal candidate will be responsive, analytical, thoughtful, self-motivated, highly organized, detail-oriented and a team-player.

Duties and Responsibilities:

• Maintain subject and document confidentiality at all times, understand and comply with the appropriate sponsor requirements and regulations which includes the Food and Drug Administration, Good Clinical Practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures

• Responsible for creating esource for document capture within site’s CTMS (CRIO) system.

• Responsible for the oversight of CTMS (CRIO) as it relates to esource and data management which is essential for daily business operations

• Collaborate with internal site staff and external personnel such as physicians, nurses, administration, industry sponsor representatives to ensure accurate eSource creation and management.

• Coordinate multiple complex projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume at multiple PCR locations.

• Responsible for the integrity of the eSource and updates version control when eSource or study documents are revised.

• Responsible for the maintenance systems necessary for document and esource version control.

• Responsible for document accuracy and security and for removing obsolete documents.

• Will lead meetings applicable to eSource

• Ensures applicable staff approve documents prior to publishing for use.

Education/Experience:

• Associate degree in scientific area of study or equivalent combination of education, training, and experience; preferred bachelor’s degree in scientific area of study

• 1-3 years related experience and/or training; Previous experience in a clinical research environment or equivalent work environment.

• Preferred clinical research coordinator with at least 1-2 years of experience

• Knowledge of regulations governing clinical research (CFR, GCP, HIPAA) required

• Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint)

• Familiarity with clinical trial management system software, preferably Clinical Research IO

• Basic medical knowledge, including medical terminology

• Demonstrated competence in oral and written communication

• Must complete CITI and GCP training certification

• Demonstrated organizational skills and outstanding time management, including keen attention to detail

• Possess impeccable integrity and personal and professional values that are consistent with Pinnacle Clinical Research high standards and mission

• Comply with the company policies, code of ethics, and guiding values at all times

Knowledge, Skills, and Other Abilities:

• Written and oral communication skills

• Strong organizational skills

• Effective presentation and training skills

• Proactive at identifying and addressing issues in real time

• Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner

• Must handle confidential matters and sensitive information with discretion and judgment

• Ability to manage large complex projects and work independently or collaboratively

• Ability to understand, execute, and interpret clinical research protocols and other applicable sponsor documents as related to data management

• People skills including possessing a positive, friendly, and professional demeanor

• Ability to be flexible with changing priorities

• Demonstrated ability to work in a fast-paced environment is highly desirable

• Strong interpersonal skills

• Excellent computer skills

• Ability to effectively lead others and be solutions-oriented

• knowledge of Microsoft Office, Internet Explorer, Google Chrome, Mozilla Foxfire, CTMS systems, EDC platforms, and web-based enterprise solutions software.

Work Environment and Physical demands:

The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Work is performed in an office/laboratory and/or a clinical environment.

• Exposure to biological fluids and/or bloodborne pathogens.

• Personal protective equipment required such as protective eyewear, garments, and gloves.

• Occasional travel may be required domestic and/or international.

• Ability to work in an upright and/or stationary position for 6-10 hours per day.

• Frequent mobility required.

• Occasional squatting, kneeling, or bending.

• Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.

Perks of working at Pinnacle Clinical Research:

• 401k

• Medical, dental, vision, long term disability, short term disability, FSA, and life insurance

• 3 weeks of paid time off

• 14 paid company holidays

• Scrub voucher (specific positions apply)

• And more!

Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.