Job Description

The Clinical Research Associate (CRA) is responsible for clinical monitoring for assigned protocols and investigational sites. The CRA reports to the Monitoring Manager or designee and is responsible for ensuring that studies are conducted and documented in accordance with the study protocol, standard operating procedures, Good Clinical Practices (GCP) and other applicable regulatory requirements.

Essential Functions Include:

• Supports the clinical team in clinical monitoring and operational study execution of assigned protocol and sites.
• Coordinates and attends CRA teleconferences (weekly or as needed).
• May assist in the design and development of study related documents including (but not limited to) monitoring guidelines, monitoring plans, CRA evaluation plans, Informed Consent Form (ICF) templates, Case Report Forms (CRFs), CRF guidelines/instructions Data Management Plans, source document templates, monitoring visit report templates, site tools and worksheets.
• Assist in the review and tracking of regulatory documents and other study related documents.
• Creates, maintains and reports metrics for monitoring study visit reports and study data.
• Conducts all types of monitoring, co-monitoring, CRA evaluations at study sites as required by the Sponsor and SOW including Phase I unit pre-study evaluations.  Provides visit feedback for evaluation by the Clinical Operations group/or designee.
• Writes trip reports or evaluation reports and follow-up letters as required by SOPs for study visits.  Also responsible for the tracking of all study visits and reports and make sure they are consistent with the monitoring plan.
• Interface with individuals in other functional areas to address study needs.
• May assist in the review of required documents for Clinical Trial Material (CTM) release authorization.
• May be asked to review protocols and other study documents.
• Performs data review, query generation and query resolution .
• Participates in meetings and conference calls with internal project teams, Sponsor teams, and external partners.
• May participate in the training of vendors, and study coordinators on study requirements. May be required to train site staff on protocol specific issues, GCPs or other necessary training.
• May be asked to review time sheets and expense reports for CRAs. Must ensure consistency with contract and travel policy.
• Up to 60% travel is possible.

Qualifications

Qualified candidates must have:

• Bachelor's degree or equivalent combination of education and experience.
• Must have 3 + years of experience as a Clinical Research Associate; for Sr. CRA position must have 5+ years or experience as a Clinical Research Associate.
• Ability to travel approximately 60%.
• Excellent verbal, written communication skills and interpersonal and presentation skills are required.
• Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel and Power Point) applications to prepare charts, tables, forms, reports and presentations required. Experience with email and calendar programs necessary.
• Electronic data capture (EDC) experience required and CTMS and IVRS system experience is a plus. 
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.
• Must be able to offer solutions when obstacles are identified and train as necessary to achieve project goals.
• Must have a general understanding of routine project goals from an organizational perspective.
• Strong organizational skills and attention to details required.  Ability to prioritize and plan workload is essential.

Additional Information

• All candidates must be legally eligible to work in the United States. 
• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.