Clinical Research Coordinator

About Cellmig Biolabs

Cellmig Biolabs specializes in pioneering innovations in translational medicine aimed at cancer diagnosis and treatment. The team has developed breakthrough biotechnologies involving cytocapsulae and cytocapsular tubes to target tumor metastasis effectively. They are currently manufacturing in vitro diagnostic products including kits and devices to detect all stages of cancer metastasis.

Job Summary

Cellmig Biolabs is seeking two Clinical Research Coordinators to assist in clinical study coordination, liaison activities with hospitals, and communications with regulatory consultants.

Key Responsibilities

• Assist in preparing and overseeing research budgets, timelines, and related financial transactions.
• Maintain and manage detailed records of study activities, including case report forms.
• Ensure adherence to study protocols and compliance with all applicable local, state, national, and institutional regulations.
• Communicate and coordinate with clinics and laboratories involved in clinical studies.
• Monitor and record research expenditures associated with clinical trials.
• Oversee the requesting, collection, labeling, storage, and shipment of study samples.
• Conduct protocol-specific procedures such as patient interviews and sample collection.
• Participate in compiling and analyzing clinical study data.
• Contribute to ensuring study protocol compliance and clinical objectives are met in collaboration with regulators.
• Engage in the development of study protocols and FDA submission documents.

Required Qualifications and Skills

• Bachelor's degree or higher in life sciences.
• Highly organized with an exceptional attention to detail.
• Strong communication skills tailored to patients, clinicians, regulatory officials, and monitors.
• Ability to clearly explain results and scientific concepts to non-specialists.
• Empathetic approach to patient interaction ('bedside manner').
• Comfortable collaborating with biology researchers and software engineers on a conceptual level.
• Effective time management and ability to prioritize tasks under pressure.
• Creative problem-solving skills and resourcefulness.
• Preferred: clinical research experience, Good Clinical Practice (GCP) certification, familiarity with IRB and FDA processes, and experience developing standard operating procedures.
• Must be a U.S. citizen.

Compensation and Benefits

The company offers competitive salary and benefits. Title and remuneration will be aligned with the candidate's experience and educational background.