Clinical Research Systems Specialist

 

 

 

Provides compliance overview and troubleshooting for clinical research management system support on multiple platforms including OnCore, eRegulatory/eConsent, Smartsheets, and Research EPIC application support, administration and training. Serves as a liaison between the Clinical Research team and the Information Services team.

 

 

Essential Functions:

• Understands and provides recommendations for application set up to align with organizational goals; responsible for coordinating details about current state along with organizational goals to inform future state design.
• Collaborates with clinical research management system end users, technical support, key stakeholders and organizational leadership to ensure institutional goals are met.
• Responsible for testing and providing feedback about test results to steering committee.
• Manages compliance aspects to ensure accurate billing activities for Clinical Research.
• Responsible for the development, implementation, and management of overall systems compliance plan. Tracks projects to ensure compliance within system standards.
• Participates in data migration-related activities.
• Develops and implements training for clinical research management system end users; provides ongoing support to end users including report writing, status updates and data support.
• Identifies requirements and develops reports to meet organizational reporting needs.
• Works with internal resources, Advarra or EPIC, where appropriate, to ensure issues are resolved in a timely manner including but not limited to departmental reports, IRB integrations and data reports.
• Coordinates the evaluation of upgrades on the test environment and provide feedback to appropriate leaders regarding impact of upgrades.
• Articulates to functional area experts the upgrades that may impact current workflow, policies, and procedures.
• Develops and uses checklists to ensure that information goes out error-free.

Education Requirement:

• Bachelor’s Degree, or equivalent experience, required.
• Master’s Degree, preferred.

Licensure Requirement:

(not specified)

Certifications:

(not specified)

Skills:

• Accountability in task ownership and solution-oriented work approach; goal oriented
• Ability to work independently using initiative and good judgment
• Working knowledgeable in the use of information technology
• Experience identifying and implementing process improvements
• Strong organizational skills including attention to detail and multi-tasking
• Exceptional interpersonal skills; ability to work within diverse teams
• Ability to filter information, discern importance and initiate plan for project completion
• Excellent verbal and written communication skills
• Detail-oriented with ability adapt to a variety of situations.
  

Experience:

• Two years of clinical research experience, or equivalent work experience, preferred.
• One year of experience with Research EPIC, OnCore, or similar clinical research management system, preferred.

Physical Requirements:

OCCASIONALLY: Color vision, Depth perception, Lifting / Carrying: 0-10 lbs, Peripheral vision, Pushing / Pulling: 0-25 lbs, Seeing – Far/near

FREQUENTLY: Bend/twist, Climb stairs/ladder, Cold Temperatures, Reaching above shoulder, Squat/kneel, Standing, Walking

CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Problem solving, Repetitive hand/arm use, Sitting

Additional Physical Requirements performed but not listed above:

(not specified)

 

 

"The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"