Clinical Research Coordinator

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.

Company Conformance Statements

In the performance of their respective tasks and duties all employees are expected to conform to

the following:

• Perform quality work within deadlines with or without direct supervision.

• Interact professionally with other employees, customers and suppliers.

• Work effectively as a team contributor on all assignments.

• Work independently while understanding the necessity for communicating and

coordinating work efforts with other employees and organizations.

Position purpose

The Clinical Research Coordinator (CRC) is a specialized research professional working with

and under the direction of the Director and Clinical Principal Investigator (PI). The CRC

supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in

the conduct of the study.

Responsibilities/Duties/Functions/Tasks:

• Communicate study requirements to all individuals involved in the study.

• Develop and implement recruitment strategies in accordance with Impact Research

and IRB requirements and approvals.

• Screen subjects for eligibility using protocol specific inclusion and exclusion criteria.

• Entry of participant information and study visit procedures into the Clinical Trial

Management System to ensure billing to appropriate funding source.

• Maintains adequate inventory of study supplies. When handling investigational

drugs/devices, follows the sponsor protocol and/or Impact Research Policy on

Investigational Drug/Device Accountability.• Complete study documentation and maintenance of study files in accordance with

sponsor requirements and Impact Research policies and procedures including, but not

limited to, consent forms, source documentation, narrative notes if applicable, case report

forms, and investigational material accountability forms.

• Maintains effective and ongoing communication with sponsor, research participants,

Director and PI during the course of the study.

• Manage the day to day activities of the study including problem solving, communication

and protocol management.

• Collects and reports ongoing patient recruitment/ enrollment metrics to Director and PI.

• Arranges secure storage of study documents that will be maintained according to Good

Clinical Practice guidelines or for the contracted length of time, whichever is longer.

• Protects the rights and welfare of all human research participants involved in research in

accordance with Federal regulations

• Cooperates with Impact Research compliance and monitoring efforts regarding the

access, use, and disclosure of PHI and reports instances of noncompliance to the

appropriate compliance office.

• Other duties as assigned.

Qualifications

Education: High school diploma/GED certificate required. Associates degree from an

accredited university preferred.

Experience: Minimum 1-2 years of clinical research experience.

Other Requirements: None

Performance Requirements:

• Knowledge of grammar, spelling, and punctuation.

• Knowledge of purchasing, budgeting, and inventory control.

• Skill in taking and transcribing dictation and operating office equipment.

• Skill in answering the phone and responding to questions.

• Skill in time management, prioritization, and multitasking.

• Skill in writing and communicating effectively.

• Ability to work under pressure, communicate and present information.

• Ability to read, interpret, and apply clinic policies and procedures.

• Ability to identify problems, recommend solutions, organize and analyze information.

• Ability to multi-task, establish priorities, and coordinate work activities.

• Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and

appropriate practice management software.

• Must be able to lift up to 25 lbs.

• Must be able to travel and MVR

Equipment Operated: Standard office equipment including computers, fax machines, copiers,

printers, telephones, etc.

Work Environment: Position is in a well-lighted medical office environment. Occasional

evening and weekend work.

Physical Requirements: Must possess the physical and mental abilities to perform tasks such as

sitting for 90 percent of the day; manual dexterity to operate office machines including computer

and calculator; stooping, bending to handle files and supplies; and mobility to complete errands

or deliveries. Stress can be triggered by multiple staff demands and deadlines.

Employee acknowledgement/date ________________________________________________

*IC= PRN, Irregular or casual; non-regularly scheduled staff

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.