Clinical Research Specialist

About the role

About the Role: We are looking for a meticulous and proactive Clinical Research Study Coordinator to join our dynamic team. In this role, you will oversee and coordinate various aspects of clinical trials, ensuring adherence to regulatory standards and study protocols. You will collaborate closely with the research team, and participants to facilitate the successful execution of research studies. 

What you'll do

Key Responsibilities:

• Oversee all phases of clinical trials, including participant recruitment, informed consent processes, and data collection.
• Maintain comprehensive and organized study documentation, such as case report forms, regulatory paperwork, and study logs.
• Schedule and conduct study visits, follow-ups, and assessments with participants.
• Ensure adherence to Good Clinical Practice (GCP) guidelines and study protocols.
• Communicate effectively with Principal Investigators, research staff, and study sponsors to ensure smooth operations.
• Monitor the progress of studies and report any issues or deviations to the Principal Investigator and sponsor.
• Assist in the preparation of study-related documentation, including protocols, informed consent forms, and regulatory submissions.
• Perform data entry tasks while ensuring data integrity and confidentiality.
• Organize and participate in study meetings, training sessions, and site visits.

Qualifications

• Bachelor’s degree in a relevant field (e.g., life sciences, nursing, public health) or equivalent experience.
• Prior experience in clinical research or a related field is preferred.
• Familiarity with clinical trial regulations, GCP, and FDA guidelines.
• Strong organizational, communication, and interpersonal skills.
• Ability to work both independently and collaboratively within a team.
• Proficiency in Microsoft Office and clinical trial management software.
• A valid Phlebotomy Certificate from the USA is required.
• US citizenship required.

Additional Consideration:

Candidates with prior experience as Medical Assistants (MAs) in pulmonary or respiratory care settings are strongly encouraged to apply. Applicants who have worked 2+ years in a pulmonary office and are familiar with patient assessments, spirometry, or chronic respiratory disease management will find this an excellent opportunity to transition into clinical research. We provide full training and ongoing support for qualified candidates interested in advancing their careers in research coordination.

If you are detail-oriented and passionate about clinical research, we invite you to apply and contribute to our mission of advancing medical knowledge through rigorous and ethical research.