Clinical Research Coordinator
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The Veterans Research and Education Foundation (VREF) is looking for a Clinical Research Coordinator. We are a non-profit corporation established to facilitate and support the medical research and educational mission of the VA St. Louis Healthcare System (VASTLHCS). We promote biomedical and health service research for the benefit of Veteran patients.Job Type: Full-time
Pay: From $39.16 per hour
Work Location: In person
Clinical Research Coordinator Duties and Responsibilities:
Performs research activities as outlined in the protocol; implementing and organizing clinical research studies assigned to him/her which includes but is not limited to:
a) Conducts clinical studies as outlined in the study protocol within the local and federal regulations and guidelines; adheres to good clinical practices.
b) Works as part of a team focused on oncology research where use of both written and verbal communication with research staff, clinical staff, patients and families is a daily necessity.
c) Prepares and processes human specimens for use in research studies. Collects blood, urine, and other samples as needed according to skill level and certifications.
d) Collects and controls research data and subject information; and maintains accurate data collection of all study data.
e) Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection.
f) Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I.
g) Enrollment of subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations. This also involves the ability to explain technical information so that it is understood by patients and their families.
h) Adheres to departmental quality control guidelines.
i) Ensures that the investigator verifies that the subject meets inclusion/exclusion criteria; verified that the subject and/or legal guardian has provided informed consent; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate.
j) Assists PI in education of other study personnel with regards to study responsibilities and keeps written documentation of this training.
k) Alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
l) Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF’s are completed prior to monitoring visits.
m) Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binders.
n) Coaches and mentors new clinical research coordinators.
o) Performs other duties and maintains schedule as required by a protocol or unit needs.
Required Abilities:
1. Associate degree or equivalent work-related experience.
2. Understanding of medical terminology and clinical trials.
3. Excellent interpersonal skills and ability to interact with staff, patients and families.
4. Skills required:
Preferred Abilities
1. Certified Clinical Research Coordinator Certification preferred
2. Experience with conducting in person study visits strongly preferred
Pay: From $39.16 per hour
Work Location: In person
Clinical Research Coordinator Duties and Responsibilities:
Performs research activities as outlined in the protocol; implementing and organizing clinical research studies assigned to him/her which includes but is not limited to:
a) Conducts clinical studies as outlined in the study protocol within the local and federal regulations and guidelines; adheres to good clinical practices.
b) Works as part of a team focused on oncology research where use of both written and verbal communication with research staff, clinical staff, patients and families is a daily necessity.
c) Prepares and processes human specimens for use in research studies. Collects blood, urine, and other samples as needed according to skill level and certifications.
d) Collects and controls research data and subject information; and maintains accurate data collection of all study data.
e) Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection.
f) Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I.
g) Enrollment of subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations. This also involves the ability to explain technical information so that it is understood by patients and their families.
h) Adheres to departmental quality control guidelines.
i) Ensures that the investigator verifies that the subject meets inclusion/exclusion criteria; verified that the subject and/or legal guardian has provided informed consent; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate.
j) Assists PI in education of other study personnel with regards to study responsibilities and keeps written documentation of this training.
k) Alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
l) Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF’s are completed prior to monitoring visits.
m) Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binders.
n) Coaches and mentors new clinical research coordinators.
o) Performs other duties and maintains schedule as required by a protocol or unit needs.
Required Abilities:
1. Associate degree or equivalent work-related experience.
2. Understanding of medical terminology and clinical trials.
3. Excellent interpersonal skills and ability to interact with staff, patients and families.
4. Skills required:
- Working knowledge of PCs and word processing and data management software,
- Verbal and written communication,
- Goal-oriented; self-directed,
- Ability to actively participate as a team player.
Preferred Abilities
1. Certified Clinical Research Coordinator Certification preferred
2. Experience with conducting in person study visits strongly preferred