In-house Cra

Job Summary
The In-House Clinical Research Associate (CRA) will assist in activities supporting the site

management and monitoring of clinical studies, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements.

The In-House CRA may also be referred to as a Clinical Trial Associate on some contracts.

Key Accountabilities/Duties/Responsibilities

• Reviews daily clinical research status and determines daily tasks.
• Under the direction of the project CRA staff oversight lead (i.e. Clinical Study Manager, Lead CRA, Project Manager, etc.) possesses basic knowledge of the study protocol, site monitoring plan, and study manuals in order to triage questions or requests from site staff (e.g., enrolment updates, questions, missing documentation, meeting arrangements, etc.).
• Has knowledge of Good Clinical Practices and country regulatory requirements.
• Collects, reviews, maintains, and tracks required sitelevel essential documents. Review

includes assessment of completeness, accuracy, and compliance with regulatory and local requirements.

• Performs upload of sitelevel essential documents into the trial master file.
• Communicates and coordinates effectively with internal project staff members and site staff.
• Completes IRB/EC submissions for sites or submits to central IRB on behalf of the site.
• Assists with site activation processes in collaboration with clinical operations counterparts.
• Assists project teams with trial progress tracking by updating the Clinical Trial Management

System and other tools.

• Under the direction of the project CRA staff oversight lead (i.e. Clinical Study Manager, Lead CRA, Project Manager, etc.) or a Senior CRA, may assist experienced CRA in the conduct remote and onsite monitoring visits such as qualification/prestudy visits, site initiation visits,

interim/routine monitoring visits, closeout visits, and for-cause visits.

• Participates in audit preparation activities as needed.
• Assists in preparing and tracking study documents.
• Assists with ordering clinical trial supplies from vendors such as laboratories and Investigational Product depots.
• Tracks project CRA deliverables such as confirmation memoranda and site visit reports.
• Prepares documents for archiving.
• May assist in feasibility activities such as feasibility questionnaire maintenance, compilation of

results, and completion of site selection/non-selection letters.

• May track site recruitment efforts and collect/review site screening logs.
• May assist the CRA in Action Item (AI) resolution post visit and assists with tracking AIs to

completion.

• May assist with the review of the database to assess data currency and may assist with resolving data queries/discrepancies.
• May assist with preparing or conducting training and retraining of site staff.
• May perform remote review and monitoring of Informed Consent Forms and other source

documents. May review site-specific language in informed consent forms prior to submission to the IRB/EC.

• Other duties as assigned.

Required Education and Experience

• Bachelor's degree (scientific discipline preferred) or directly applicable work experience preferred
• Previous 12 years CRO experience preferred (as a CTA, inhouse CRA, etc.)

Required Skills/Abilities

• Proficient with MS Office Suite
• Excellent computer and organizational skills
• High attention to detail required
• Ability to work on varying projects and exercise critical thinking
• Selfstarter who can work independently and a team player who can work cross functionally with limited oversight
• Knowledgeable in clinical research operations, including interpretation and implementation of countryspecific regulations/ICH guidelines, as required
• Excellent organizational, interpersonal, and communication skills (both oral and written)
• Demonstrated problemsolving skills, selfmotivated, and adaptable to a dynamic environment
• Knowledgeable in prioritization, problemsolving, organization, critical thinking, decision making, time management, and planning activities
• Ability to collaborate with internal and external colleagues and work well in a teamoriented setting

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