Respiratory Therapist (2460)

Looking for a Respiratory Therapist with 3 years of clinical research coordinator experience to work at site with our clinical team.  Performs and interprets spirometry tests, which measure lung capacity and airflow. They are responsible for preparing patients, operating the spirometry equipment, and recording and reporting results. 

Duties & Responsibilities:

• Performing Spirometry Tests:

  Conducting spirometry tests according to established standards, such as those set by the DM Clinical. 

• Equipment Maintenance:

  Ensuring the spirometry equipment is properly calibrated and maintained. 

• Patient Preparation And Education:

  Explaining the procedure to patients, ensuring their comfort, and guiding them through the test. 

• Result Interpretation:

  Analyzing and interpreting spirometry results, including FVC, FEV1 and FEV1/FVC ratios. 

• Record Keeping:

  Accurately documenting and inputting test results into electronic medical records. 

• Communication:

  Communicating findings to respiratory therapists, physicians, or other relevant healthcare professionals. 

Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:

• Sponsor-provided and IRB-approved Protocol Training
• All relevant Protocol Amendments Training
• Any study-specific Manuals Training, as applicable
• Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
• Conducting and overseeing study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
• Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
• Completing and overseeing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
• Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
• Demonstrated understanding, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols.
• Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives for assigned protocols.
• Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)
• Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).
• Ability to train and mentor site staff, as needed
• Supervise visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)
• Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
• Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).
• Maintaining a working knowledge of Study Participants’ Scheduling, Visit Tracking, Stipends and Transportation by liaising with the Administrative team.
• Maintaining a working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)
• Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.
• Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
• Being prepared for and available at all required company meetings.
• Submitting required administrative paperwork per company timelines.
• Occasionally attending out-of-town Investigator Meetings
• Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
• Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
• Facilitate effective communication between patients, healthcare providers, and research staff

Knowledge & Experience

Education:

• High School Diploma or equivalent required
• Bachelor's degree preferred
• Foreign Medical Graduates preferred

Experience:

• Minimum of 3 years experience in Clinical Research
• Minimum of 3years experience in Spirometry 
• Regulatory research experience is a plus

Credentials:

• ACRP or equivalent certification is preferred

Knowledge And Skills:

• Goals-driven while continuously maintaining quality.
• Must be detailed-oriented, proactive, and able to take initiative.
• Must have strong written and communication skills.
• Must have excellent customer service skills.
• Proficient communication and comprehension skills both verbal and written in the English language are required.
• Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.