Clinical Research Associate - Level 2

PURPOSE

Under the administration of the Director of Data Operations and Report, the Clinical Research Associate-2 will contribute to the support of breast and colorectal cancer research and the management of clinical trials by assisting project teams with study specific documentation and guidelines while meeting all project team and departmental goals.

ESSENTIAL FUNCTIONS

• Provide general administrative support to the Clinical Trial Team and assistance to Project Manager(s) and Director(s).
• Collaborate with the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
• Setup, organize and maintain clinical study documentation (e.g. main study files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
• Assist in quality control audits of clinical study documentation (e.g. main study files, CRF files, monitoring files).
• Coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.
• Track trial progress by updating the Clinical Trial Management systems.
• Copy and route incoming correspondence, internal documentation, CRFs, etc. as appropriate.
• Coordinate investigator payments, if applicable.
• Contact clinical sites for specific requests (e.g. enrollment updates, missing documentation, meeting arrangements).
• Track and distribute safety reports.
• Arrange document translation, if required.
• Attend project team meetings and prepare meeting minutes.
• Assist the Project Manager and project team with investigator meeting coordination, activities preparation and meeting minutes.
• Organize the production of slides, overheads, etc. as needed for project, departmental, sponsor and/or business development presentations.

OTHER RESPONSIBILITIES

• Maintain professional knowledge by reviewing professional publications, attending professional meetings, and establishing personal networks.
• Understand the policies, procedures, regulations, and practices necessary to conduct the normal function of this position.
• Maintain confidentiality and perform duties in a responsible and ethical manner.
• Perform additional duties as may be assigned.

EXPERIENCE/SKILLS

• 2-4 years research or health related experience preferred
• Familiarity with ICH, GCP and appropriate clinical research regulations
• Strong organizational skills with meticulous attention to detail
• Ability to multitask and manage time well
• Strong written and verbal communication skills
• Computer literacy skills (Microsoft Word, Excel, Outlook and Power Point)

This position is located in Pittsburgh, PA. We offer a hybrid work schedule of 3 days in the office (Monday, Tuesday and Thursday) and 2 days remote work (Wednesday and Friday) per week.

The NSABP Foundation, Inc. is an Equal Employment Opportunity and Affirmative Action Employer committed to the value of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, national origin, physical or mental disability, protected veterans, genetic information, and sexual orientation.