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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