A CRC III (with Spirometry Experience) will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. To ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.

DUTIES & RESPONSIBILITIES

• Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
• 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:
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  • 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
• Any other matters as assigned by management

KNOWLEDGE & EXPERIENCE

Education:

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

Experience:

• Minimum of 5 years experience in Clinical Research
• Supervisory experience preferred
• Wide therapeutic range of clinical trials experience preferred
• 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.