In-House Cra Jobs

Remote | Must be located in the United States

IN-HOUSE CLINICAL RESEARCH ASSOCIATE

The In-House Clinical Research Associate (CRA) is part of the Study Management Team that is responsible for successful management and execution of clinical trials. This position is an in-house position, with minimal travel associated with co-monitoring activities.

CORE RESPONSIBILITIES:

• Performs document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, invoices, and other study documentation
• May assist with study entry and updates to ClinicalTrials.gov
• Executes meeting logistics (e.g., schedule meetings, distribute meeting agendas and minutes), as needed
• Presents at team meetings as needed (i.e., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training, etc.)
• Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents
• Assists with the tracking and management of study specific budgets
• Assists with oversight of study vendors
• Collects and reviews essential documents from investigational sites
• Assists with design and preparation of study related materials for the training of internal and external staff
• Travel is variable and estimated at 20%
• Collaborates with the Clinical Trial Manager and/or the Clinical Project Lead on the development of certain study-specific plans and/or processes
• Participates in development of departmental processes, SOPs, and initiatives
• Develops and maintains good working relationships with Investigators and study staff
• Prepares investigational site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)
• Assists in development of study materials, case report forms (CRFs), informed consent documents for clinical studies
• Assists in the organization and preparation of and participates in Investigator Meetings (as applicable)
• Participates in study specific tasks such as investigator identification, recruitment, collection of regulatory documents and site activation
• Contributes to the development of the Monitoring Plan and assists with ensuring appropriate quality and timely monitoring of clinical sites
• Participates in co-monitoring activities and oversight of CRO or contract field CRAs for pre-study, initiation, routine monitoring and closeout visits
• Helps facilitate resolution of data queries and requests from Clinical Data Management
• Acts as primary contact for study contractors (e.g., contract CTMs, field CRAs)
• Works with internal and external team members (i.e. Clinical Supplies, Toxicology PK, Regulatory Affairs, Clinical Data Management and CRO/Vendors) to deliver high quality trial execution
• Keeps the Clinical Project Lead (CPL) informed of the progress of projects
• Performs study tracking (e.g., CTMS, start-up, milestone, close-out); generates, reviews and distributes management reports from internal tracking systems at requested intervals

COMPETENCIES IDENTIFIED FOR SUCCESS:

• Effective written and verbal communication skills
• Effectively collaborates with Clinical Trial Team members
• Outstanding organizational skills with the ability to multi-task and prioritize
• Exceptional attention to detail
• Proven flexibility and adaptability
• Good judgment in triaging issues from internal and external customers
• Sound problem-solving capabilities
• Able to critically evaluate job tasks and the impact on overall trial management objectives
• Ability to work in a team or independently

EDUCATION, EXPERIENCE, AND OTHER REQUIREMENTS:

• Experience in scientific discipline and multiple therapeutic areas preferred
• Proficiency in MS Office including Word, Excel, and PowerPoint
• Bachelor’s Degree preferred
• Minimum of two (2) years in clinical research or healthcare related industry, or equivalent combination of education and experience; site monitoring experience a plus
• Experience/training in the following areas: GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance), HIPAA, Drug Development and Approval Process