1. Manages processing, tracking, and filing of study documents and updates including adverse and serious adverse events, IND Safety Reports, Investigator Brochures, Package Inserts, and Instructions for Use.  2. Collaborates with Investigators, study teams, and Project Managers to gather, review, and maintain essential regulatory documents.  3. Collates aggregate study data into reports for external audiences including data and safety monitoring groups, regulatory authorities, and project funders. 4. Assists Project Managers in study oversight responsibilities and supports study management activities including drafting and revising study specific materials. 5. Manages study systems set up, access, and revisions, including Clinicaltrials.gov, CTMS (OnCore), Electronic Data Capture Systems, and regulatory document systems.  6. Assists in implementation of improvements and, solutions and assistance as needed under the supervision of senior team members. 7. Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments. 8. Assists in the development and preparation of budgets. 9. Manages administrative support for activities of one or more departments to ensure timely completion of projects. 10. Ensures compliance with University and federal regulations as they apply to the assigned departments. 11. Assists in reviewing and implements University and departmental policies as they pertain to the administrative functions of the assigned department. 12. May perform other duties as assigned.

Required Skill/ability 1:  Professionalism, good judgement, and ability to work with confidential material and protected health information.  Strong interpersonal, oral and written communication skills and ability to work effectively with a wide variety of external and internal stakeholders.

Required Skill/ability 2:  Self-directed with the ability to work, plan, research and manage multiple studies with minimal supervision, on a flexible schedule and with best practice expertise for low to moderately complex trials and non-therapeutic trials.

Required Skill/ability 3:  Ability to manage multiple/diverse low to moderately complex trials and non-therapeutic trials studies simultaneously.  Proven ability to multi-task and remain focused in a fast-paced environment.

Required Skill/ability 4:  Analytical in nature and assignments range from low to moderately complex to co-support planning. Decisions are guided by clear to obscure guidelines and policies and can have a moderate short-term impact to the areas of which they are accountable.

Preferred Education:  Experience with communicating through social media. Management skills in implementing large projects. Ability for conversational Spanish, or fluency in Spanish.

Work Week:  Standard (M-F equal number of hours per day)

Posting Position Title:  Clinical Trials Project Specialist

University Job Title:  Clinical Trials Program Specialist

Preferred Education, Experience and Skills:  Experience with communicating through social media. Management skills in implementing large projects. Ability for conversational Spanish, or fluency in Spanish.

Bachelor's Degree in related field and two year of related experience or an equivalent combination of education and experience.

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