Shift: Full time, Days

Reporting to the Clinical Research Manager, serves as the primary resource for assigned clinical research studies. Promotes the research program and recruits potential research patients to participate in upcoming research studies. Conducts patient screening and follow-up visits, collecting all required data and may perform various clinical duties including taking vital signs, and performing study specific tasks such as EKG’s.

1. Provides education to patients regarding protocol /informed consent. Uses protocol-specific patient tracking spreadsheet to track patient accrual. Acts as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals. Works with patients and Research Manager as appropriate to address barriers and patient satisfaction with care. Schedules patients for study visits.

2. Works with internal departments such as lab and pathology to collect required study specimens such as tumor tissue and blood. Processes biological samples (blood, urine, feces) as per study lab manual and sends to study lab as described in study documents.

3. Uses EPIC, department rounds, tumor boards, and review of upcoming patient consultations to identify potential patients for clinical trials. Ensures person obtaining consent has correct consent version. Ensures that all tests and treatments ordered/scheduled per protocol and abnormal results are assessed by PI.

4. Tracks adverse events through a tracking spreadsheet. Reports adverse events to investigator, applicable IRB and sponsor in timely manner as applicable and may follow up with patient and or family. Facilitates dispensing of study drug, as appropriate.

5. Maintains study source documents. Manages and updates all regulatory documents. Submits initial request for IRB approval along with all amendments, investigator brochures, continuing reviews, terminations, and any other applicable study documents to the relevant IRB’s within required timeframe. Documents all patient encounters in electronic medical record per NCH Policy. Completes data entry in study established Electronic Data Capture systems, resolves queries and adheres to protocol data management plan.

6. Retains all research related records according to regulations, guidelines and NCH policy. Receives and signs off on all study related supplies provided by the sponsor; acknowledges receipt via sponsor’s web site. Performs final reconciliation duties at study closure including drug accountability and return and document filing. Serves as back-up Coordinator for studies assigned to others as needed.

7. Enters clinical trial into EPIC. Links study patients to clinical trial and links appropriate visits, labs, imaging, and procedures to study. Runs Research Coordinator Billing Review weekly and performs research charge correction as required. Sends notification to Clinical Research Manager for items needing to be invoiced to sponsor as needed. Submit contracts and requests for revisions to contracts or budget to Clinical Research Manager as obtained.

8. Communicates opportunities to open applicable, appropriate studies to Research Manager. Contribute to discussions regarding feasibility of protocol implementation. Completes all required training, and ensures study staff has current training. This includes study specific training, human subjects protection course and good clinical practice per FDA, OHRP, NCI, NCH IRB and NCH policy. Participates in educational opportunities to address identified knowledge and skill gaps related to role. Attends off site meetings study meetings and reports back to study team.

9. Adheres to all Northwest Community Hospital standards, policies, and procedures.

Qualifications

1. The level of knowledge normally obtained through the completion of a Bachelor’s Degree in a medical field or equivalent on the job training.

2. Certified Clinical Research Coordinator (CCRC) through ACRP, or Certified Clinical Research Associate (CCRA) through SOCRA, preferred.

3. Minimum of 6 months progressively responsible experience as a Research Coordinator with strong knowledge of the clinical research study process required.

4. In depth knowledge and understanding of FDA regulations, IRB standards and Good Clinical Practices (GCP’s) governing clinical trails, including completion of GCP certificate, required.

5. Proficiency using Microsoft programs including Outlook, Word, Excel and Power Point required.

6. Proficiency using electronic data captures systems (EDC’s) and submitting documents electronically.

7. Valid Illinois driver’s license and access to an automobile to travel to various sites.

8. The interpersonal skills necessary to interact effectively with all levels of staff, physicians, external contacts and patients.

9. Excellent verbal and written communication skills necessary to prepare, develop and present information in a clear and concise manner.

10. Organizational skills to effectively coordinate multiple research studies.

11. The ability to multi-task and shift priorities when necessary.

12. Detail oriented with the ability to maintain complete and accurate research documentation.

13. The ability to speak, read and write in English and Spanish a plus.

PHYSICAL REQUIREMENTS:
1. Requires light physical effort. May require periods of standing or walking. May require frequent lifting or moving of lightweight material, occasional moving of average weight items, and rare lift of heavy weight material (most materials would be related to paper goods and study supplies).
2. The flow of work and character of duties involves normal mental and visual attention much or all of the time.
WORKING CONDITIONS:
1. Conditions are acceptable. At least one disagreeable element or hazard is frequently present in the environment, i.e. infectious disease, while several disagreeable elements of hazards are occasionally present.

About Us
Serving Chicago's northwest suburbs since 1959, we are an independent, not-for-profit healthcare system dedicated to providing outstanding care in the communities we call home. Our comprehensive, patient-centered system of care has dozens of locations throughout the area.
Our award-winning care has been recognized on a national level. Some of our top awards include:

• America's 250 Best Hospitals™ Award recipient for three years in a row from Healthgrades®
• Magnet® designation for nursing excellence, received consecutively since 2006
• The Joint Commission's Gold Seal of Approval and Comprehensive Stroke Center designation

Our team includes:

• 4,000 employees
• 1,200 physicians on staff
• 200 primary are and specialty physicians

Annually, we treat an average of 20,000 inpatients and provide:

• 350,000 outpatient visits
• 76,000 emergency department visits
• 38,000 home care visits
• 2,700 newborn deliveries

A growing healthcare system
Over the years, we have continued to grow to meet the area's changing needs. Today, we're a world-class healthcare provider that combines compassionate care with a healing environment, cutting-edge clinical expertise and state-of-the-art facilities, including:

• A 509-bed hospital, including the South Pavilion with 200 private rooms
• The William J. and Marian H. Busse Center for Specialty Medicine, an eight-floor facility housing physician offices, medical specialty services and advanced diagnostic technology
• A Level III NICU, Level II Trauma Center and a dedicated pediatric emergency department
• Five Immediate Care Centers, in Buffalo Grove, Kildeer, Mount Prospect, Palatine and Schaumburg
• 23 physician offices in Arlington Heights, Buffalo Grove, Kildeer, Mount Prospect, Palatine, Rolling Meadows and Schaumburg
• Nine outpatient imaging locations that provide advanc emergency department
• Five Immediate Care Centers, in Buffalo Grove, Kildeer, Mount Prospect, Palatine and Schaumburg
• 23 physician offices in Arlington Heights, Buffalo Grove, Kildeer, Mount Prospect, Palatine, Rolling Meadows and Schaumburg
• Nine outpatient imaging locations that provide advanced imaging technology, including MRI, CT, ultrasound, X-ray and 3D mammography
• 13 clinical laboratory sites in seven suburbs and at the hospital
• 33-bed acute inpatient rehabilitation unit and seven outpatient rehabilitation centers
• The Wellness Center, a premier health and fitness center and spa on the NCH campus
• A full-service, retail pharmacy on the hospital campus