![St. Charles Health System](https://media.trabajo.org/img/noimg.jpg)
Clinical Research Coordinator
2 weeks ago
Typical pay range:
$ $34.30 per hour, based on experience, in addition to a 15% differential on top of the hourly base rate in lieu of benefits.
ST. CHARLES HEALTH SYSTEM
JOB DESCRIPTION
TITLE: Clinical Research Coordinator I
REPORTS TO POSITION: Research manager
DEPARTMENT: Research
DATE LAST REVIEWED: October 8, 2018
OUR VISION:
Creating America's healthiest community, together
OUR MISSION:
In the spirit of love and compassion, better health, better care, better value
OUR VALUES:
Accountability, Caring and Teamwork
DEPARTMENTAL SUMMARY: St. Charles Research Department conducts clinical trials for promising new treatments and therapies in a wide variety of medical fields, including cancer treatment and prevention, cardiovascular disease and supportive care.
POSITION OVERVIEW:
The Clinical Research Coordinator I is responsible for conducting clinical trials in compliance with FDA regulation, ICH Guidelines and applicable industry standards. The Clinical Research Coordinator 1 will oversee ten or more clinical trials as the main research coordinator.
This position does not directly manage other caregivers, however may be asked to review and provide feedback on the work of other caregivers.
ESSENTIAL FUNCTIONS AND DUTIES:
Maintains surveillance system to identify potential subjects for study eligibility, prescreen patients, and assists physicians in determining eligibility.
Obtains informed consent according to GCP and ICH guidelines.
Performs study procedures and assessments following protocol specific guidelines.
Assures research is conducted in an ethical and safe manner according to FDA, ICH and St. Charles Health System guidelines.
Adheres to St. Charles Health System's compliance plan.
Attends IRB meetings as requested by the IRB.
Supports the processing of study alerts, protocol revisions, amendments, accrual suspension notices, informed consent modifications, product information and advertisement, and related memoranda.
Prepares for and participates in required sponsor and regulatory audits.
Attend Investigator meetings as required to assure seamless study start-up.
Assists with subject education and informed consent process, including tissue and genetics consent when indicated. Surveys for re-consent and obtains from eligible subjects.
Educates patients regarding protocol diagnostic tests and assists with appointments.
Process tissue/blood specimens and prepare it for shipment.
Manages treatment and follow-up schedules to assure protocol compliance.
Attends subject clinic visits and interacts with subjects and staff as appropriate to assist in protocol adherence.
Track study drug usage per protocol and oversee study drug supply.
Maintains subject research records including long-term follow up and reporting.
Participates in institutional research activities (committee meetings, Tumor Boards, Grand Rounds, other conferences, etc.) that are relevant to the Position.
Participates in quality assurance program for St. Charles Health System and affiliated research partners.
Supports the vision, mission and values of the organization in all respects.
Supports Value Improvement Practice (VIP- Lean) principles of continuous improvement with energy and enthusiasm, functioning as a champion of change.
Conducts all activities with the highest standards of professionalism and confidentiality.
Complies with all applicable laws, regulations, policies and procedures, supporting the organization's corporate integrity efforts by acting in an ethical and appropriate manner, reporting known or suspected violation of applicable rules, and cooperating fully with all organizational investigations and proceedings.
Delivers customer service and/or patient care in a manner that promotes goodwill, is timely, efficient and accurateMay perform additional duties of similar complexity within the organization, as required or assigned.
EDUCATION:
Required: High School Diploma or GED.
Preferred:
Bachelor of Science degree in related field preferred or equivalent research experience.
LICENSURE/CERTIFICATION/REGISTRATION
Required: Must obtain Association of Clinical Research Professional (ACRP) Certification within three years of full time employment. Current Current American Heart Association (AHA) Basic Life Support for Healthcare Provider certification, or obtained within 90 days from employment.
Preferred: N/A
EXPERIENCE:
Required: None Required.
Preferred: Experience as a Clinical Research Coordinator. Experience dealing with multidisciplinary teams. Basic Clinical task knowledge.
ADDITIONAL POSITION INFORMATION:
N/A
PHYSICAL REQUIREMENTS:
Continually (75% or more): Use of clear and audible speaking voice and the ability to hear normal speech level.
Frequently (50%): Sitting, standing, walking, lifting 1-10 pounds, keyboard operation.
Occasionally (25%): Bending, climbing stairs, reaching overhead, carrying/pushing or pulling 1-10 pounds, grasping/squeezing.
Rarely (10%): Stooping/kneeling/crouching, lifting, carrying, pushing or pulling 11-15 pounds, operation of a motor vehicle.
Never (0%): Climbing ladder/step-stool, lifting/carrying/pushing or pulling 25-50 pounds, ability to hear whispered speech level.
Exposure to Elemental Factors
Never (0%): Heat, cold, wet/slippery area, noise, dust, vibration, chemical solution, uneven surface.
Blood-Borne Pathogen (BBP) Exposure Category
No Risk for Exposure to BBP
Schedule Weekly Hours:
0
Caregiver Type:
Relief
Shift:
First Shift (United States of America)
Is Exempt Position?
No
Job Family:
COORDINATOR CLERICAL
Scheduled Days of the Week:
Monday-Friday
Shift Start & End Time:
8-5
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