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*This is FT 1.0FTE, 40 hr/week position*
The Clinical Research Coordinator's (RN) primary responsibility is managing the elements of clinical research studies in order to meet the NIH/NICHD Pediatric Pharmacology Research Unit?s research obligations. These may include study investigator meetings, start-up activities, launch activities, day to day management of a study and study closure activities. Included in these responsibilities are: enrollment of study subjects according to local, state and federal regulations; Institutional Review Board (IRB) study submissions and record-keeping, protection of human subjects and subjects' rights ; implementing and organizing Phase I-IV studies assigned to him/her. This includes subject scheduling, record keeping, data collection and study procedures within the local and federal regulations and guidelines.
1. Prepares (or assists local Principal Investigator (PI) in preparation) protocol for local Human Subjects Institutional Review (IRB). Coordinates response(s) of investigators to IRB comments/contingencies. Coordinates IRB submission of any study amendments. Files required notification of adverse events, protocol deviations or yearly (or as required) study updates to maintain IRB approval. Files documents as necessary to close out study with local IRB.
2. Coordinates site visits by the sponsor, their designate or regulatory agencies.
3. Completes required regulatory documents (e.g. CV's certifications, FDA1572, etc.) for study start-up and any regulatory issues after a study has been initiated by the study sponsor; maintains regulatory binder.
4. Coordinates budget preparation with the study PI.
5. Performs research activities as outlined in the protocol. Some of the procedures may be invasive such as venipuncture, IV insertion and injections. These are performed as dictated by the protocol and according to recognized skill level and certifications; collaborates, coordinates, and schedules subject study visits with other hospital services with the PI/sub-I; conducts subject data collection, alerts the investigator when the subject's safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination. Prepares specimen(s) for storage and/or shipment as required by the study protocol.
6. Verifies that the subject meets inclusion/exclusion criteria; verified that the subject and/or legal guardian has provided signed informed consent/assent; answers questions related to the protocol and/or procedure as applicable; acts as a patient/family advocate.
7. Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management; documents required observations on source documents as required by the protocol.
8. Completes Case Report Forms (CRFs) as instructed by the sponsor; available to the sponsor at initiation and monitoring visits. Also completes associated documents such as Serious Adverse Event (SAE) forms and protocol deviations.
9. Manages screening sheets and recruitment logs, and completes recruitment summary at study termination. Collects and enters study screening and enrollment data as required by the NIH/NICHD to fulfill PPRU award (in addition to sponsor reporting requirements). Assists PI as necessary in preparation of NIH required reports.
10. Develops and maintains Standard Operating Procedures (SOP's) for the PPRU.
11. Attends conference calls and/or meetings as required by the PPRU grant.
12. Coordinates investigational medication issues with the Pharmacy. Administers investigational medications per protocol in accordance with study and hospital procedures.
KNOWLEDGE , SKILLS AND ABILITIES REQUIRED
1. Graduate of an approved school/college of nursing and licensed for practice as a registered nurse in the State of Ohio; BS/BSN preferred.
2. At least 3 years of nursing experience; preferably pediatrics
3. Understanding of medical terminology and clinical trials preferred.
4. Skills required: Working knowledge of PCs and word processing and data management software. Verbal and written communication. Goal-oriented; self-directive. Initiation, motivation, creativity. Organizational and interpersonal. Ability to actively participate as a team player
MINIMUM PHYSICAL REQUIREMENTS
Physical requirements may include lifting, carrying, pushing, pulling, standing, walking, sitting, climbing, balancing, stooping, kneeling, reaching, finger dexterity, talking, hearing, seeing, etc.
If possible, minimum physical requirements should be described in terms of the amount (e.g., weight ) and duration (e.g., occasionally = 0-33%, frequently = 34 ? 66%, constantly = 67-100%) of specific physical effort required to perform the essential functions. For example: Lifts objects weighing up to 30 pounds. Constantly 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.