Clinical Research Coordinator II

Planet Pharma; Lufkin (TX); On-site; USD 41,000 - 44,000; Full time

Job summary

Planet Pharma in the United States is seeking a Clinical Research Coordinator (CRC) to support an ongoing study with data entry, query resolution, and other CRC activities. The ideal candidate will have CRC experience and strong collaboration skills, with a diplomatic, agile, and adaptable approach in interactions with stakeholders.

The role emphasizes adherence to GCP/ICH, IRB processes, and accurate data handling, including patient bookings and sponsor system entries.

Qualifications

• Bachelor’s degree or equivalent and relevant formal academic qualification in the clinical/medical field.
• 2+ years’ experience in a CRC role or similar clinical research position.
• Solid understanding of GCP, SOPs, informed consent and safety monitoring.

Responsibilities

• Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Record patient information and test results on required forms.
• Complete IP accountability logs and related information as needed.
• Report suspected non-compliance to site staff.
• Ensure IRB approval and compliance throughout the study.
• Promote the company and build positive patient relationships to support retention.
• Attend site initiation and related trainings to learn protocol.
• Call patients, schedule bookings, and perform follow-up communications as needed.
• Log data in sponsor systems and ensure accuracy and timeliness.
• Gathers and maintains source documents and up-to-date patient files.
• Adhere to COP/SCOP; assist with waste disposal and site neatness.

Skills

Clinical research knowledge

Communication skills

Attention to detail

Problem solving

Team collaboration

English fluency

Education

Bachelor’s degree or equivalent in clinical/medical field

Job description

Summarized Purpose

Clinical Research Coordinator (CRC) to support an ongoing study with data entry, query resolution, and other CRC activities. The ideal candidate will have previous experience working as a CRC and demonstrate a strong collaborative approach. They should be diplomatic, agile, and adaptable, with strong interpersonal skills and an ability to work effectively and constructively with different stakeholders.

Essential Functions

• Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.


• 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


• 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

30-32/hr based on experience