Clinical Research Coordinator
Full time
Cellmig Biolabs is a world-class team making pioneering discoveries into translational medicines for the diagnosis and pharmatherapy of cancer metastasis and growth. We have successfully developed new organelle of cytocapsulae/cytocapsular tubes related breakthrough biotechnologies in generating biomolecules propertied powerful potentials targeting tumor metastasis. We are producing the in vitro diagnosis products (kits and devices) for the detection of cancer metastasis in all (early, developing and late) stages.
Cellmig is searching for 2 clinical research coordinators for clinical research, communication between company and hospitals and regulatory consultants.
Roles and Responsibilities:
- Participate preparation and control of research budgets, timeline, and financial payments
- Manage necessary records of study related activity which includes case report forms
- Keep track of study activities to make sure compliance with protocols and with all related local, state, and national regulatory and institutional polices
- Communicate with clinics and laboratories
- Track all research expenses for clinical studies
- Direct the request, collection, labelling, storage, or shipment of samples
- Perform specific protocol procedures (interviewing patients, collection of samples)
- Take part in compiling clinical study data and analyses
- Participate monitoring compliance with protocols and clinical objectives with all relevant regulators
- Take part in development of protocols and FDA submissions.
Requirements:
- Bachelor’s degree or more in a life sciences field
- Meticulously organized
- Excellent communication skills to interface with patients, clinicians, regulators, monitors
- Ability to communicate results and concepts clearly to laypeople
- Empathetic “bedside manner”
- Ability to interface on a conceptual level with biology researchers and software engineers
- Ability to prioritize and think on the spot
- Exceptional time management
- Able to efficiently find creative solutions to problems
- Nice-to-haves: Clinical research experience, Good Clinical Practice (GCP) training; Experience developing standard operating procedures (SOPs); Experience working with a licensed IRB and the FDA
- USA citizen only
Cellmig offers a competitive salary and benefits. Title and compensation based on experience and education.