In-House Clinical Research Associate

In-House Clinical Research Associate

Remote - Rochester, NY

A Trusted CRO Partner for the Future of Eye Care

iuvo Clinical is a full-service ophthalmology-focused contract research organization (CRO) dedicated to improving patient's quality of life with breakthrough eye care therapies. We combine decades of specialized experience with a high touch, high science approach, partnering with innovators to accelerate ophthalmic breakthroughs from concept to commercialization. Whether advancing a novel retinal therapy or supporting a complex ocular device trial, we provide the expertise, flexibility, and personal dedication to ensure your clinical trial's success.

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

We currently have an exciting opportunity for an In-House Clinical Research Associate.

SUMMARY

The In-House Clinical Research Associate (IHCRA) plays a key role in the clinical study team by providing operational support to iuvo clinical trials. The IHCRA acts as the primary point of contact for investigative sites upon site activation.

ESSENTIAL DUTIES AND 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

QUALIFICATION REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION and/or EXPERIENCE

• 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).

COMPUTER SKILLS

• Experience working with EDC, CTMS and other clinical trial systems is preferred.
• Proficiency with Microsoft Office (Word, Excel, Outlook, Teams) and other software/programs as applicable to position.

COMMUNICATION SKILLS

Effective verbal and written communication skills required to interact with clinicians, clients, vendors, FDA Inspectors and internal project team members through demonstration of:

• 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

ORGANIZATIONAL SKILLS

• 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

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to sit, stand and walk, use hands to manipulate objects or controls, reach with hands and arms, talk and hear.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Office setting.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

LOCATION Remote

TRAVEL <5% travel

DISCLAIMER

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

iuvo Clinical is an Equal Opportunity Employer