Clinical Research Coordinator II

Planet Pharma; New York (NY); 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. Responsible for data capture, patient safety, and coordination with site teams and sponsors. Requires experience as a CRC and relevant nursing licensure.

Responsible for informed consent, visits scheduling, data entry, and IRB compliance. Strong attention to detail and communication in English preferred.

Qualifications

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

Responsibilities

• Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines
• Provide medical care to patients with patient safety as priority
• Schedule subject visits within protocol windows and maximize capacity
• Perform informed consent, screening and protocol procedures (vital signs, tests, ECGs, etc.)
• Record patient information and results on required forms
• Maintain source documents and update patient files accurately
• Support IRB approvals and ensure ongoing compliance
• Promote company and maintain patient retention
• Attend site initiation and protocol training meetings
• Log data in sponsor systems and ensure timely completion
• Dispose of waste according to standards and maintain facility cleanliness

Skills

Clinical research

Regulatory understanding

Attention to detail

Independent worker

Education

Bachelor’s degree or equivalent (clinical/medical)

RN/LVN/LPN license & local registration

Tools

EDC systems

Documentation systems

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. Candidates should have previous experience working as CRC.

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/hr