Clinical Research Associate

General Position Overview

The Clinical Research Associate (CRA) / Senior CRA is responsible for assisting with clinical trial management, site management, data review and cleaning, and occasionally leading the planning and development of the study set-up, execution, and may assist with oversight of clinical study while ensuring the trial is conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs/Work Instructions.

Key Accountabilities/Core Job Responsibilities

Study Planning and Conduct: 

• Acts as primary point of contact for vendors, investigational sites and cross functional teams and escalates to the study lead as necessary
• Supports and occasionally leads the development/review of clinical study plans, presentations or project/study-related documents including contracts/site payments Supports in the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT
• Responsible for oversight and mentoring of junior team members
• Performs in-house review of clinical data listings for completeness and accuracy and escalate issues to the lead or above as needed
• Manages clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
• Responsible for the distribution of study newsletters, tracking and reporting of recruitment updates
• May occasionally assist the clinical management staff with the development, approval, and distribution of study-related documents including Case Report Forms (CRFs), study protocols, study manuals, and other study tools to investigational sites and review committees, as applicable.
• Participate in clinical study team meetings.
• Collaborates with internal cross functional teams (i.e., Clinical Science, Biometrics, Regulatory Affairs, etc.), to ensure effective delivery of the assigned project milestones

Site Monitoring Activities:

• Ensuring compliance with the CFR, GCP and all internal SOPs and guidelines
• Communicating project progress, challenges, and opportunities on a regular basis to Clinical Leadership both verbally and written.
• Monitoring clinical and/or laboratory data to ensure accuracy, thoroughness, and regulatory compliance of clinical documentation, and ensuring resolution of data queries.
• Monitoring all safety issues and continuous site evaluation and working with Clinical Team Leader to resolve.
• Monitor SAE reporting and request primary and follow-up information according to SOP.
• Review protocol violations with the investigator and take corrective actions to ensure future compliance.
• Responsible for the reconciliation of drug accountability records at sites.
• Responsible for the reconciliation of all regulatory documents at sites.
• Provide timely monitoring reports in accordance with SOPs.
• Assist Data Management in the resolution of data queries.
• Ensure availability of all study supplies at sites and participate in other tasks as needed.
• Performs pre-study site qualification visits to evaluate adequacy of site, investigator and designated site personnel.
• Performs ongoing monitoring visits at assigned investigational sites to verify that the rights and wellbeing of human subjects are protected, and the reported clinical data is accurate, complete and verifiable from source documents.
• Performs close-out visits as well as other activities associated with the completion of a clinical trial.
• Reviews records to ensure clinical studies are conducted in compliance with currently approved protocols, applicable regulations, work instructions, guidelines and/or policies.
• Ensures site compliance with the clinical study protocol, documentation and resolution of monitoring issues, safety, investigational product accountability/accuracy, preventative/corrective action plan implementation to prevent recurrences.
• Assist in query writing and resolution process, as required.
• Ensures study documentation is accurately and properly maintained at investigational sites.
• Provides on-site training of investigators and other site personnel.
• Collaborates with cross-functional teams in evaluation of safety data, investigational product tracking, compliance, data management, etc.
• Communicates with internal clinical study team to ensure adherence to timelines for site monitoring and clinical study activities.
• Communicates with clinical sites to expedite the exchange of information and assure that clinical studies are kept on schedule.
• Organization of study files, inventory and all related study materials.
• Ensures that clinical sites have adequate supplies of product and material to effectively conduct the study.
• Attends and/or performs site initiation visits as needed.
• May occasionally assist with supplying content for mass communications, newsletters, and study coordinator training/conferences, etc., as needed.

General:

• Maintains completion of required corporate training on standards, policies, work instructions by due date Performs other work-related duties as assigned

Qualifications

• B.S. degree
• 5 years of CRA experience monitoring clinical trials in biotech, pharmaceutical, or CRO environment
• 8 years for Sr. CRA
• Experience with trial conduct from start-up through close out
• Working knowledge of relevant ICH GCP and FDA regulations
• Ability to work effectively with minimal supervision
• Ability to multi-task and manage deliverables across all assigned trials
• Strong written and verbal communication skills
• Ability to travel frequently 
• Self-motivated and able to work in a small team environment