Clinical Research Assistant

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

Job Title: Clinical Research Assistant

Location: GHP New Albany/Louisville

Reports To: Manager, Clinical Research

Job Summary:

The Clinical Research Assistant, under the guidance and supervision of the Clinical Research Manager and Principal Investigator (PI), ensures the integrity and quality of clinical trials are maintained and conducted in accordance w/ federal, state, and local regulations, Institutional Review Board (IRB) approvals, and Impact Research policies, and procedures. This position is primarily responsible for the accurate completion of visit procedures and collection of information for study patients according to protocols, and for protecting the health, safety, and welfare of research participants.

FLSA: Non-Exempt

Supervisory Responsibility: This position has no supervisory responsibilities

Key Responsibilities

• Assist in the implementation of clinical research studies.
• Recruit, screen, and enroll study participants.
• Coordinate and schedule study visits and follow-ups.
• Collect, process, and manage biological samples.
• Maintain accurate and detailed records of research activities.
• Communicate with research participants and address their concerns.
• Ensure compliance with regulatory and ethical standards.
• Assist in the preparation of study-related documents and reports.
• Monitor study progress and report any adverse events or protocol deviations.
• Coordinate with clinical research coordinators, other departments and staff involved in the study.
• Other duties as assigned

General

• Adopt the Impact Research culture of respect, integrity and accountability that contribute to an internal environment of teamwork and promote a positive brand image to our external customers.
• Incorporate a leadership mindset to your role.
• Comply with Impact Research procedures, policies, and regulations relevant to your role.
• Successfully completes all Impact Research training requirements (i.e. OSHA, HIPAA, HealthStream, compliance, etc.)
• Responsible for compliance with all regulatory requirements and/or guidelines. These requirements/guidelines include, but are not limited to: OSHA, HIPAA, Federal Fraud and Abuse laws.
• Computer skills - good working knowledge of MS office.
• Ability to communicate effectively with others, both verbally and in writing.
• Proven ability to manage time, meet deadlines and prioritize.
• Able to maintain standards and professionalism during periods of fluctuating workloads.
• Provide professional service to direct customers of Impact Research in all interactions.
• Build effective working relationships with other team members.
• Manage daily tasks to ensure business needs are consistently met.

Education and Qualifications

• High School Diploma or equivalent required.
• Previous experience in clinical research or healthcare setting preferred
• Associate's or Bachelor's degree in a relevant field preferred
• Basic understanding of clinical research principles and methodologies.
• Strong organizational and time management skills.
• Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or willingness to learn and demonstrate proficiency within three months of hire
• Ability to work independently and as part of a team.
• Ability to follow protocols and guidelines closely.
• Basic knowledge of medical terminology.
• Ability to handle sensitive and confidential information.

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 speak and hear. Understand/comprehend English as well as read/follow written English instructions.

This role requires continuous activity levels in areas such as walking, standing, pushing, pulling, lifting, and reaching. It also requires dexterity in motion/flexibility. Ability to lift, push or pull 35+ or more. Must be able to differentiate colors and successfully pass color blind screening.

Work Environment

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stoop as necessary. This position requires the ability to occasionally lift office products and supplies up to 20 pounds. This job operates in a professional office environment. This role routinely uses standard office equipment.

This job operates in a clinic and procedure room environment. There is potential to be exposed to blood, tissue, and bodily fluids. Involves exposure to Glutaraldehyde/Rapicide (Refer to SDS manual as needed). Occasional exposure to communicable diseases and biohazards.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Accommodations

Reasonable accommodations will be made to enable a qualified individual with a disability to perform the non essential or essential functions of this job. All accommodations will be investigated on an individual basis with the needs of the department and current staff resources considered. Accommodations will not be made that compromise the safety and health of any associate.

At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.