Third Pole is on a mission to expand the lifesaving benefits of Nitric Oxide inhalation therapy, making it accessible to millions of respiratory challenged newborns and adults around the world. This is a rare opportunity to be part of a rapidly growing team, making a huge social impact, touching the lives of those we love and care about most.

We are a fast-paced developing a game-changing technology that generates Nitric Oxide on demand, at the patient location, from the air we breathe. Our Third Pole community is grounded in the values of collaboration, embracing diverse ideas, commitment, and transparency without the politics found in most companies. Our motto is we are only successful if we all cross the finish line together! Sound like you?

The In-House Clinical Research Associate (IHCRA) will work closely with the Clinical Project Manager (CPM), Lead Clinical Research Associate (CRA) and the CRA team by providing support to the study team members. The IHCRA performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the protocol, Standard Operating Procedures (SOPs), International Council for Harmonisation (ICH)/ Good Clinical Practice (GCP) guidelines, ISO-14155, and all applicable regulatory requirements.

JOB FUNCTIONS/RESPONSIBILITIES:

The IHCRA:

· Supports study start-up activities, such as investigator identification, recruitment, collection of Investigator’s essential documents, site activation, negotiation of site contracts and budgets, review of Institutional Review Board (IRB) / Independent Ethics Committee (IEC) submission materials.

· Assists with Central IRB/IEC submissions and responds to IRB/IEC inquiries, as needed.

· Assists with the organization and conduct of study-specific meetings, including the preparation of agendas, slides, and minutes.

· Coordinates study material [e.g., study manuals, Investigator Site File (ISF)] shipment and receipt by study sites.

· Addresses non-medical site questions and liaises with study team members regarding study site issues.

· Documents site contact and study interactions in a timely and professional manner.

· Provides general support to the CPM and CRA team to manage the investigative sites and ensure compliance with applicable regulatory requirements, ICH/GCP guidelines and SOPs.

· Maintains the Frequently Asked Questions (FAQ) list throughout the study, as needed.

· Develops or contributes to newsletters based on information provided by the study team.

· Ensures essential documents are filed in the study specific Trial Master File (TMF) and in accordance with the Drug Information Association (DIA) Reference Model.

· Conducts routine TMF audits to ensure that all study files are accurate, current, complete, and audit ready.

· Prepares or provides input on study-specific documentation and plans, status reports, and tracking.

· Performs remote or onsite monitoring activities as outlined in the Clinical Monitoring Plan and Case Report Form Completion Guidelines.

· Assists with ensuring site compliance with Investigational Product receipt, accountability, and return/destruction, as applicable and appropriate.

· Assists with data cleaning activities including writing and resolving queries.

· Assists with the handling and follow-up of Serious Adverse Events (SAE)/ Serious Adverse Device Effect (SADE)/ Device Deficiencies (DD) documentation.

· Conducts monitoring visit report review, as applicable.

· Coordinates Investigator site payments, as applicable.

· Performs the tracking of study-specific training.

· Assists with document routing and change control within the Quality Management System.

· Performs any other duties required to ensure the success of the study and Third Pole.

QUALIFICATIONS EDUCATION/EXPERIENCE:

· Undergraduate degree in a clinical, biological, scientific, or health-related field from an accredited institution; a licensed health care professional (e.g., registered nurse); or equivalent work experience required.

· Minimum 2 years of clinical research experience required.

· Working knowledge of ICH/GCP, ISO-14155, FDA, MDR, and EU Regulations, as applicable.

KNOWLEDGE, SKILLS AND ABILITIES:

· Excellent verbal and written communication skills; excellent interpersonal and organizational skills with demonstrated attention to detail.

· Good computer skills with good working knowledge of a range of computer applications (e.g., Word, Excel, PowerPoint).

· Strong critical thinking, problem solving and analytical skill sets.

· Excellent organizational and time-management skills, able to meet deadlines and work independently in a fast-paced environment.

· Ability to maintain excellent working relationships with individuals from a broad range of backgrounds.

· Ability to work well in a team environment but also independently with oversight.

· Accountable, dependable, and strong commitment to the study.

· Maintains a positive, results-orientated work environment.

· Read, write, and speak fluent English.

· Willing to travel as needed to fulfill study objectives, not to exceed 15%.

Equal Opportunity Employer

Third Pole, Inc. provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law.

Reasonable Accommodations

The job summary, responsibilities and requirements listed above are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the responsibilities and skills required of this position. Reasonable accommodations may be made for any part of the application or interview process, and to enable qualified individuals with a medical condition or disability to perform the essential functions.