Job Description
Clinical Research Systems Coordinator - (Clinical Conductor experience required)
Department: Clinical Systems
Employment Type: Full Time
Location: Alcanza Corporate
Reporting To: Tina White
Description Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
The Clinical Systems Coordinator is a hands-on role focused on the operation of clinical systems for Alcanza Clinical Research. The Clinical Systems Coordinator works closely with clinical systems operations staff, IT, system vendors, and Alcanza staff to address user needs, troubleshoot issues, and facilitate system enhancements. This position also works closely with the Clinical Systems Team to build and manage CTMS data points related to study milestones, enrollment goals, and study status changes. This position requires a combination of technical expertise, communication skills, and attention to detail to contribute to the success of clinical trials and research studies at Alcanza Clinical Research.
Key Responsibilities Essential Job Duties:
- Assist in the configuration and customization of clinical systems to meet the specific needs of research studies and operational workflows.
- Maintain accurate and up-to-date system settings, including user access permissions, study parameters, and data fields.
- Collaborate with IT professionals to ensure the proper functioning and integration of clinical systems with other organizational platforms.
- Participate in the evaluation and implementation of system upgrades, enhancements, and new software applications.
- Conduct testing and validation of system changes to ensure functionality and usability.
- Assist in managing CTMS data points, including milestone dates, enrollment goals, study status changes, and any necessary adjustments post-protocol opening, as directed by Operations leadership.
- Coordinate the development and maintenance of integrations between clinical systems, including API and ODBC connections.
- Coordinate with vendors to address system issues, implement enhancements, and stay informed about platform updates. Work closely with IT, Finance and HR departments to maintain accurate system accesses, manage permissions, and implement security measures such as MFA and SSO.
- Stay abreast of updates to SaaS platforms, disseminate patch notes to relevant stakeholders, and manage version control and release processes.
- Ensuring ongoing validation and providing documentation to sponsors as required.
- Lead system and data migration processes, ensuring data integrity and minimizing operational disruption.
- Maintain a comprehensive inventory of all active systems and manage their lifecycles in accordance with the IT Governance committee's directives.
- Provide application-level support to users, including oversight and coordination with software vendor support to optimize system modules and address user issues.
- Serve as the resource for implementing, modifying, and upgrading clinical systems, providing continuous support and training for users.
- Coordinate training sessions and provide resources to enhance user proficiency and efficiency.
- Other related duties as assigned.
Skills, Knowledge and Expertise Minimum Qualifications: An Associate's degree and 1+ years' related experience with clinical research systems OR an equivalent combination of education and experience is required. Knowledge of Clinical Conductor CTMS required. Knowledge of CRIO eSource and Florence eBinders highly preferred.
Required Skills:
- Strong proficiency with computer applications such as Microsoft applications, email, web applications, as well as clinical research systems applications.
- Strong organizational skills and attention to detail.
- Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, management, and external customers.
- Well-developed written and verbal communication skills.
- Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
- Must be professional, respectful of others, self-motivated, and have a strong work ethic.
- Must possess a high degree of integrity and dependability.
- Ability to work under minimal supervision, identify problems and implement solutions.
- Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
Working Conditions: Alcanza complies with the Americans with Disabilities Act (ADA) and all other applicable state and federal fair employment practices laws and is committed to providing equal employment opportunities to qualified individuals with disabilities. Consistent with this commitment, Alcanza will provide a reasonable accommodation to disabled individuals if the reasonable accommodation would allow the individual to perform the essential functions of the job, unless doing so would create an undue hardship. Alcanza will not discriminate or retaliate against any individual for requesting an accommodation. The physical demands listed below represent those that are needed to meet the essential functions of the position.
• May be required to travel approximately 10% of the time, dependent on business needs.
Benefits - Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
Job Tags
Full time, Temporary work,