Senior 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.

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 ResearchPolicy 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 4 or more years of clinical research experience.

Other Requirements: CRC certification preferred.

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.

At Iterative Health were 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