Note: The job is a remote job and is open to candidates in USA. iuvo Clinical is a full-service ophthalmology-focused contract research organization dedicated to improving patient’s quality of life with breakthrough eye care therapies. The In-House Clinical Research Associate plays a key role in the clinical study team by providing operational support to clinical trials and acting as the primary point of contact for investigative sites.

Responsibilities

• Perform remote monitoring activities on a regular basis in real time inclusive of but not limited to:
• Review data in EDC system, issue and resolve queries
• Maintain a level of accuracy that minimizes data query rate, identify data entry issues and trends, resolve said issues or escalate as appropriate
• Confirm accuracy and data integrity
• Review data for protocol compliance and re-educate sites as needed
• Identify action items
• Evaluate overall performance of site and site staff, provide recommendations as needed, escalate issues as needed
• Assist Safety Surveillance group to reconcile and facilitate adverse event and serious adverse event reporting and documentation as needed
• Document remote monitoring activities on appropriate report template per study-specific plans/requirements
• Provide supplemental EDC training for sites as needed
• Assist in communications with data management group as necessary
• Participate in data cleaning prior to data locks
• Supplement onsite monitoring activities as needed
• Identify high-risk sites and bring to the attention of Clinical Operations for additional training and/or corrective action
• Interact with site staff to confirm smooth operation and documentation of trials under Good Clinical Practice (GCP) guidelines
• Possess knowledge of the current study protocol(s), site monitoring plan, study manuals, and applicable systems
• Maintain a working knowledge of ICH/GCP Guidelines, Code of Federal Regulations, local country regulatory requirements and relevant FDA regulations
• Review and understanding of iuvo SOPs, work instructions and guidelines and any Sponsor- specific requirements
• Provide input to study plans and associated tools/forms as needed
• Organize, prepare and ship applicable clinical study binders to clinical sites (regulatory binders, questionnaires, etc.) as needed
• Attend internal and external team calls to stay informed of current study status and provide feedback/updates as needed
• Promptly submit time and expense reports as applicable and adhere to project-level budget requirements. Escalate issues as needed
• May mentor other internal study-team members as needed/applicable

Skills

• Bachelor's degree, or equivalent research experience, preferably in a life science, nursing, or related discipline
• Minimum two years of relevant work experience in clinical research operations
• Strong working knowledge of GCPs and Federal Regulations
• Current GCP certification required (or willing to obtain)
• Effective verbal and written communication skills required to interact with clinicians, clients, vendors, FDA Inspectors and internal project team members
• Excellent presentation and interpersonal skills, including clear, succinct, and timely communication
• Sharing ideas in a constructive and positive manner
• Listening to and objectively considering ideas and suggestions
• Keeping commitments
• Keeping others informed of work progress, timetables and issues
• Addressing problems/issues constructively to find mutually acceptable solutions
• Respecting the diversity of our work force in actions, words, and deeds
• Read and comprehend work instructions/SOPs and protocols and write clear concise reports
• Must be able to efficiently schedule/perform follow-up of tasks, manage multiple priorities, and organize time with a strong attention to detail and analytical skills
• Experience working with EDC, CTMS and other clinical trial systems

Benefits

• We offer a comprehensive benefits package and the opportunity to broaden your experience and grow your career!

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