Clinical Research Coordinator

Northwestern Medicine; Lake Forest (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

Northwestern Medicine is seeking a Clinical Research Coordinator to coordinate trials under the Principal Investigator, ensuring compliance with policies and regulations. The role involves patient care, handling investigational medications, and coordinating site visits and sponsor communications.

The position requires a Bachelor's degree or equivalent, plus 2+ years in clinical research and strong organizational and communication skills.

Qualifications

• Two years' experience in managing all aspects of clinical research trials.
• In-depth knowledge of protocol requirements and Good Clinical Practice.
• Excellent written and verbal communication abilities.

Responsibilities

• Facilitates and coordinates logistical aspects of study protocols with staff.
• Provides direct patient care and dispenses investigational medications under PI direction.
• Attends meetings and site visits, coordinates required visits and visits by monitors.
• Schedules protocol-related procedures and ensures study documentation is complete.
• Maintains communication with investigators, subjects, sponsors and IRB.
• Ensures data entry into CRFs with source documentation verification.

Skills

customer service

communication

organizational skills

computer skills

Education

Bachelor's degree or equivalent

Job description

Description

The Clinical Research Coordinator reflects the mission, vision, and values of NM, adheres to the organization's Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.

The Clinical Research Coordinator is a clinically competent professional responsible for all aspects of coordinating a clinical trial as delegated by the Principal Investigator under all applicable policies, procedures and regulations.

Responsibilities

• Facilitates, maintains, and coordinates the logistical aspects of assigned study protocols with other research staff in accordance with Good Clinical Practice, standard operating procedures and sponsor requirements.
• Provides direct patient care pursuant to a study protocol including dispensation of investigational medications and performance of study tests under the delegation and direction of the principal investigator or supervising physician.
• Attends investigator's meetings, coordinates and attends pre-study site visits, study initiation visits, and all other study-related visits by Monitors or Sponsor representatives, when required.
• Arranges for procedures and necessary visits performed by external vendors that are necessary to the conduct of the study.
• Schedules and leads in-house protocol meetings to review study-related procedures, staffing and visit flow.
• Schedules and coordinates all medical needs and coverage for protocol related procedures.
• Maintains and documents all study-related communication including, but not limited to the principal investigator or supervising physician, study subjects, Sponsor or Sponsor representative(s) and IRB throughout the clinical trial.
• Responsible for giving subject instructions for study participation and serves as the primary contact for subjects by being available to handle study-specific questions, concerns, or events.
• Ensures all protocol procedures are completed per study requirements.
• Obtains and documents all adverse event data on appropriate forms and reports adverse event data to the appropriate parties as outlined by the study protocol, regulations and applicable policies and procedures.
• Assures quality and completeness of source documents collected during the course of the study to assist with overall principal investigator review and approval.
• Ensures accurate, complete and timely data entry into CRFs using 100% source documentation verification to assist with overall principal investigator review and approval.
• Schedules, leads and assists with all study-related visits on site and is readily available during visits for applicable corrections, questions, or other study-related or site needs.
• Supervises document retention, security and destruction, where applicable.
• Responsible for completing all necessary training for the position, including study protocol specific training and Health System policies and procedures.
• Trains other study specific research staff in collection and reporting of required data, where applicable.
• Maintains research files, designs forms as needed, reports findings as appropriate, assists in preparation or review of material for submission to an IRB including reviewing and editing protocols and consent documents, where applicable.
• Performs all other functions as related to this job and assigned.
• Ability to travel between hospital locations where research is conducted.

Qualifications

Required

• Bachelor's Degree in related fieldor equivalent experience in in lieu of a degree.
• Two years' experience in managing all aspects of clinical research trials with in-depth knowledge of protocol requirements and Good Clinical Practice.
• Intermediate computer and internet knowledge.
• Excellent customer service and patient care skills.
• Meticulous organizational skills.
• Excellent demonstrated written and verbal communication abilities.

Preferred

• Three to Five years' experience in clinical research trials.
• ACRP or SOCRA certification.

Equal Opportunity

Northwestern Medicine is an equal opportunity employer (disability, VETS) and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.

Background Check

Northwestern Medicine conducts a background check that includes criminal history on newly hired team members and, at times, internal transfers. If you are offered a position with us, you will be required to complete an authorization and disclosure form that gives Northwestern Medicine permission to run the background check. Results are evaluated on a case-by-case basis, and we follow all local, state, and federal laws, including the Illinois Health Care Worker Background Check Act.

Artificial Intelligence Disclosure

Artificial Intelligence (AI) tools may be used in some portions of the candidate review process for this position, however, all employment decisions will be made by a person.

Benefits

We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events.

Please refer to the Benefits Eligibility by Employment Classification to determine benefits eligibility for job postings.

If sign-on bonus is included in a job posting eligibility is as followed: Internal employees and rehires who left Northwestern Medicine within 1 year are not eligible for the sign-on bonus. Exception: New graduate internal employees seeking their first licensed clinical position as a Registered Nurse at NM may be eligible.