Clinical Research Coordinator II

Planet Pharma; Miami (FL); On-site; USD 28,000 - 40,000; Full time

Job summary

Planet Pharma is seeking a study coordinator to support a large US clinical study. You will ensure data capture, subject safety, and protocol adherence while collaborating with the site team and cross‑functional staff.

Responsibilities include informed consent, scheduling visits, data entry, source document maintenance, IRB coordination, and retention activities to support study success across the site network.

Qualifications

• Bachelor’s degree in clinical/medical field or equivalent
• Must hold a valid nursing license (RN, LVN, LPN) and be registered with local health care authority
• 2+ years of relevant experience or equivalent

Responsibilities

• Conduct studies in accordance with FDA/GCP and ICH guidelines.
• Provide medical care prioritizing patient safety.
• Schedule subject visits within protocol windows.
• Perform study activities including informed consent and protocol procedures.
• Record patient data and test results on required forms.
• Maintain IP accountability logs where required.
• Report suspected non-compliance to site staff.
• Ensure IRB approvals and ongoing compliance.
• Engage patients to support retention and sponsor relationships.
• Attend training and site initiation meetings.
• Log information into sponsor systems accurately and timely.
• Maintain source documents and up-to-date patient records.
• Adhere to COP/SCOP and keep the facility tidy.

Skills

Clinical research process

Independent work

Discretion and judgement

Decision-making & negotiation

Communication skills

Organization

Computer basics

Teamwork

Education

Bachelor’s degree in clinical/medical field

Valid nursing license (RN/LVN/LPN)

Job description

Summarized Purpose:

Study coordinator to support ongoing large clinical study in US. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, retention of study participants, data entry and query resolution.

Essential Functions:

• Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provides medical care to patients, always ensuring patient safety comes first.
• Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.
• Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG’s, etc.).
• Records all patient information and results from tests as per protocol on required forms.
• Where required, may complete IP accountability logs and associated information.
• Reports suspected non-compliance to relevant site staff.
• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attends site initiation meetings and all other relevant meetings to receive training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adheres to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.

Education and Experience:

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field
• Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).

Knowledge, Skills and Abilities:

• Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.).
• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
• Demonstrated ability to exercise discretion and sound judgement
• Good decision-making, negotiation and influencing skills
• Good communication skills and English fluency will be an advantage
• Good organizational skills
• Good proficiency in basic computer applications
• Good interpersonal skills to work in a team environment

Pay Rate Range: $20 – $29.08