Clinical Research Coordinator

MNGI•Minneapolis, MN

11d•$60,154 - $69,181•Hybrid

About The Position

The Clinical Research Coordinator will coordinate with the Principal Investigator (PI) and Department Manager to ensure clinical research activities are performed in accordance with Federal regulations, GCP, MNGI policies, and sponsoring agency requirements. This role involves protocol preparation, reviewing study materials, facilitating monitoring visits, and conducting research activities such as participant recruitment, informed consent, data collection, and managing investigational products. The position requires effective communication with sponsors, CROs, and participants, as well as managing regulatory documents and ensuring compliance with safety and privacy protocols.

Requirements

Two years of experience as a Clinical Research Coordinator with experience managing device or pharmacology trials.
Knowledge of Microsoft Office applications.
Knowledge of medical terminology.
Skills in compassionate patient care, active listening, problem-solving, prioritization, and critical thinking.
Strong attention to detail and organizational skills.
Ability to multitask, communicate effectively, work independently and in a team, and type proficiently.

Nice To Haves

Bachelor's degree in a science-related field.
One to two years of experience with an electronic health record.
CCRC (Certified Clinical Research Coordinator) certification.

Responsibilities

Coordinate with PI and Department Manager to ensure research activities align with Federal regulations, GCP, and MNGI policies.
Assist the PI in developing training materials for research staff and documenting training completion.
Coordinate and facilitate monitoring and auditing visits.
Review and comprehend research protocols and prepare study materials like informed consent documents and case report forms.
Develop and implement recruitment strategies in collaboration with the Research Recruitment Specialist.
Conduct the informed consent process with research participants.
Screen subjects for eligibility based on protocol criteria.
Manage, dispense, and collect investigational products.
Complete and document intake and protocol-specific procedures.
Maintain comprehensive knowledge of protocol timelines and manage study supplies.
Submit and maintain timely regulatory documents to the IRB, sponsors, and regulatory offices.
Prepare and maintain research-related regulatory documents and assist in audit preparation.
Report protocol deviations and safety events to the sponsor and IRB.
Submit closeout documents to the IRB and manage secure storage of study documents.
Adhere to all Federal regulations and MNGI policies regarding protected health information (PHI).