The Clinical Research Coordinator II's primary responsibility is managing elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; start-up activities, launch activities, day to day management of a study and study closure activities.
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) Establishes a strong working knowledge of all governing regulations and policies relating to clinical research and the job in accordance with:i) NCHii) FDAiii) NIHiv) State of Ohiov)
Any other applicable regulatory bodiesb) Conducts clinical studies as outlined in the study protocol; performing study procedures according to recognized skill level and certifications adheres to good clinical practices.
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. Performs CLIA waived laboratory assessments. Such activities may be performed independently and may require evening and weekend hours. Obtain and maintain IATA certificate.
d) Collects and controls research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures (if applicable). Ensures PHI is collected and maintained in a secure manner.
e) Assists in the recruitment plan, in cost estimation when applicable; manages screening documentation and recruitment logs, and completes recruitment summary at study termination.
f) Creates source documents that facilitate systematic, accurate, comprehensive data collection.
h) Aid in protocol execution and management, record keeping; and conducts accurate and timely subject data collection, ensure all reports requiring medical interpretation are reviewed and signed off by an investigator in accordance with all applicable regulations.
i) Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-Ij) Enrollment of subjects according to ICH/GCP regulations, and subjects? rights through institutional IRB, federal and state regulations;
k) Adheres to departmental quality control and administrative guidelines and processesl) Ensures all requirements have been met to begin enrollment prior to screening first subject
m) Verified that the subject and/or legal guardian has provided informed consent/assent; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate;
n) Ensures that the investigator verifies that the subject meets inclusion/exclusion criteria (prior to randomization for drug studies);
o) Assists PI in education of other study personnel with regards to study responsibilities and keeps written documentation of this training.
p) Alerts the investigator when the subject?s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
q) Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF?s are completed prior to monitoring visits.
r) Schedules, prepares study data for, and attends monitor visits, audits, or other meetings as required for the study.
s) Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder in conjunction with the regulatory coordinator office.
t) Performs other duties and maintains flexible schedule as required by a protocol or unit needs.
Reports to: Team Leader, Clinical Research ServicesKNOWLEDGE, SKILLS AND ABILITIES REQUIRED
1. Associates degree or equivalent work related experience; BA/BS preferred.
2. Minimum of 2 year experience in clinical research
3. Proficient in study start up processes; Initiation of the Clinical Research Competency Program
4. Certification by the Association of Clinical Research Professionals or Society of Clinical Research Administrators
5. Understanding of medical terminology and clinical trials required Skills required:? Working knowledge of PCs, word processing, and data management software? Strong verbal, written, interpersonal communication ? Goal-oriented; self-directive? Initiation, self-motivation, creativity, flexibility? Organizational and detail oriented ? Ability to actively participate as a team player
MINIMUM PHYSICAL REQUIREMENTSNote frequency as Constantly (67-100%), Frequently (34-66%) and Occasionally (0-33%) for each requirement. Also note any lifting requirements with pound limit.AGE(S) OF PATIENTS SERVED:Pediatric and select adult patients __X__ Yes ___ ___NoMINIMUM PHYSICAL REQUIREMENTS:Talking on phone/in person; frequently (34-100%)Sitting; frequently (34-100%)Standing/Walking; frequently (34-100%)Lifts objects weighing up to 25 pounds; occasionally (0-33%)Typing on keyboard; occasionally (0-33%)The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.EOE M/F/Disability/Vet