JOB VACANCY ANNOUNCEMENT

Summary of The Position:

The Clinical Systems Associate will provide day-to-day technical and administrative support for various Clinical Systems, including the Clinical Trial Management System (CTMS), and the electronic Trial Master File (eTMF) as well as components of the Quality Management System. This position includes supporting end users of the systems on general needs, entering subject visit data and site information, delivering, and participating in training new users on the systems, and resolving questions/issues arising in a timely manner. Through the application of systems and processes, the role will also help FHI Clinical become more efficient in utilizing automation that will promote transparency for the work that we do.

Essential Functions:

1. Handles day-to-day operations and system administration for a small portfolio of clinical applications.
2. Assists manager with supporting current users of the applications and may include Provisioning new users.
3. Troubleshoots user access issues.
4. Assists projects for clinical applications as needed including but not limited to creation of Accounts/Contacts within systems, entering subjects and subject visit dates.
5. May include assisting with the planning and execution of interoperability activities of two or more systems.
6. Collaborates with key stakeholders, to develop and maintain manuals, quick reference guides, training materials, templates procedures, and other supportive procedural documents associated with Clinical managed systems.
7. Manages (including tracking) issues noted by system users, including those requiring submission to Clinical system vendor helpdesk.
8. In regard to the Quality Management System (QMS)

8.1. Maintains general role specific curriculums for Clinical Operations functional areas. 8.2. Assists with creating the placeholders for project specific training curriculums. 8.3. With the guidance of clinical operations functional leads, assigns training to clinical operations team members.

8.4. May confirm user access to QMS accounts.

9. Regarding the eTMF system (responsible for, but not limited to):

9.1. Communicates with TMF Contributors issues identified, provides support to ensure users can manage their content into the eTMF system in a timely and accurate way.

10. Regarding the Clinical Trial Management System (CTMS)

10.1. Enters data into CTMS for specific projects, accounts, and contacts.

10.2. Optimizes CTMS to function efficiently and effectively within the organization. 10.3. Resolves helpdesk tickets specific to CTMS issues and questions including but not limited to: visits completed in error with payments issued against them; assignment of staff to roles and rights as needed; responding as necessary with re-training opportunities. 10.4. Facilitates the implementation of the CTMS within the organization.

10.5. Assists with managing access and roles within the CTMS system.

10.6. Works with the individual Clinical Project Managers (CPM), TMF Content Owners and their delegates in the management of each study CTMS.

10.7. Works with Clinical Operations and Quality in generating metrics for review in CTMS activities.

10.8. Provides support, as necessary, with interface capabilities between the CTMS and eTMF system for the transfer of study-specific documents to the study-specific eTMF. 10.9. Maintains a thorough knowledge of the organization and adheres to all organizational standards.

10.10. Keeps immediate supervisor well-informed of activities and recommends corrective actions.

10.11. Collaborates with identified stakeholders to assist in the development of organizational needs to develop processes within CTMS for better workflow.

10.12. Identifies organizational needs, addresses any problems, and develops processes within CTMS. Collaborates with related departments on organizational processes perform using CTMS.

10.13. Assists in the development and delivery of training programs specific to CTMS processes to all staff regardless of location.

10.14. Provides appropriate support to all staff within organization who use CTMS. 10.15. Collaborates with vendor and FHIC’s stakeholders in CTMS new release management including testing of new features; set up of new features; development of processes related to new features; implementation and rollout; and processing and resolution of any identified issues.

10.16. Assists in tracking of any identified bugs, defects, or enhancement CTMS requests from within organization.

10.17. Respects confidentiality in discussing consumer/participant, staff, volunteer, and organizational matters; also maintains confidentiality of organization, project, fiscal and personnel related information.

10.18. May perform other duties not specifically listed in this job description as assigned by the manager.

Knowledge, Skills, and Abilities:

• Knowledge of clinical research processes, including working knowledge of all functional areas of clinical trial management (experience with relational databases is helpful)
• Strong communication skills (verbal and written) to express complex ideas. • Exceptional attention to detail and follow through.
• Excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff.
• Must be able to do multiple tasks and have a level of flexibility that can support group priorities across the company and staff needs.
• Ability to train clinical staff at all levels within the company.
• Proficiency in working with Word, Excel, and PowerPoint as well as PDF software/programs (Adobe, Foxit, etc.).
• Working knowledge of current ICH/GCP guidelines and applicable country specific regulations. • Willingness and ability to travel domestically and internationally as required. • Willingness and ability to work across multiple time zones.

Position Requirements

Education: Bachelor’s Degree or its International Equivalent.

Preferred Job-related Experience: Two (2) years’ experience with back-end database usage. Strong proficiency in operation of computer systems required. Strong knowledge and experience of clinical trial processes. CRO experience in the Clinical Operations functional area, experience with Clinical Trial Management Systems and previous data management experience preferred.

Additional Eligibility Qualifications: Experience with data extraction (exporting and formatting data from electronic systems which will be used for internal/external reporting). Excellent ability to collaborate across departments and disciplines. Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic. Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters and other confidential information.

Preferences: Experience with the following systems preferred: Oracle Siebel Clinical (CTMS), TMF (PhlexGlobal, Trial Interactive), LeapFile, Smartsheet.

Physical Expectations:

• Typical office environment.
• Ability to sit and stand for extended periods of time.
• Ability to lift or move 5-15 lbs. or 2.26 – 6.8kg.

Travel Requirements:

Expected travel time is 10% for this position.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.

FHI Clinical, Inc. and its subsidiary and affiliate companies provide equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.

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The deadline for application is Friday, April 7, 2023, at 5pm