Clinical Research Coordinator Job Santa Barbara area,California USA,Healthcare

Overview

Job Title:

Clinical Research Coordinator I

Department:
Clinical Research

Reports to:

Director, Clinical Research Operations

FLSA Status:
Non-exempt

Job Status:
Full Time

Responsibilities

The Clinical Research Coordinator will be assigned to pharmaceutical studies, device clinical trials, and/or investigator-initiated research projects. This position works under the supervision of Principal Investigator(s) and Director, Clinical Research Operations whose research activities are conducted under good clinical practice (GCP) guidelines. This is an onsite position. Work hours will need to be flexible to meet individual project needs. Evening, weekend, and overnight hours may be required.

Attendance at departmental and weekly general staff meetings is expected.

Fulfills the following specific functions:

Responsible for the integrity and overall quality of assigned clinical research trials

Responsible for organizing and leading assigned studies

Communicates with the sponsor’s site monitors, Clinical Research Associates (CRAs), and local and/or central Institutional Review Boards (IRBs)

Prepares, schedules, and leads and/or participates in study visits with monitors, sponsors, and auditors

Follows GCP regulations, state and local laws, and study protocols

Participates in the Informed Consent process, potentially including drafting, amending, and conducting Informed Consent visits with study subjects

Reviews protocols to ensure each study fits with the SDRI mission statement and that we can actively recruit the required subject population and conduct the study successfully

Create and maintain source documents

Completes Case Report Forms (CRFs) for assigned studies and enters electronic data as required by the study

CRFs will be completed and up-to-date prior to site monitor visits
Changes or corrections noted by the monitors will be completed before the next scheduled monitor visit date or as specified by the sponsor’s deadline

Completes and submits Adverse Event (AE) forms per protocol and regulatory guidelines and Serious Adverse Events (SAE) forms to the sponsor and the IRB within 24 hours of SAE occurrence

Supervisees recruitment process for assigned studies, screens potential subjects, and conducts subject visits

Establishes and maintains relationships with study subjects and participates in subject education regarding the clinical trial process, and provides specific trial information to each subject/volunteer

Completes regulatory documents for assigned studies, including submission for IRB initial approval and applicable renewals

Attends Investigator Meetings as assigned

Maintains drug and device accountability and dispensing logs for assigned studies

Clinical duties include, but are not limited to:

Completion of comprehensive medical history for study subjects
Measure vital signs, weight, and height of study subjects per protocol and reports any abnormal results to the Principal Investigator or sub-Investigator
Phlebotomy and blood sample processing according to universal blood borne pathogen precautions
Ordering outside laboratory tests and/or procedures on an as-needed basis

Laboratory duties include:

Centrifugation of blood samples
Processing and packaging of body fluid samples (including but not limited to blood, urine, and saliva)
Proper shipment of samples, including contacting the appropriate courier

Maintains cleanliness and order in all of the designated areas during studies. Complies with Safety Committee policies and recommendations

Assists with medical writing as appropriate and assigned, including protocols, scientific papers, and grant writing

Other duties as assigned by superiors

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Training will be provided where necessary and specific assistance in refreshing the incumbent in those areas where appropriate. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Basic knowledge of accepted clinical research practices, including universal precautions, human subjects research protocols, and HIPAA requirements
Knowledge of drug development process, ICH guidelines, and FDA CFRs
Ability to lead studies independently
Ability to handle 3 or more studies simultaneously
Ability to work independently and with careful attention to detail as well as in collaboration with other staff members
Basic knowledge of office practices and office equipment
Basic knowledge of computer systems for word processing, electronic mail, data entry, and electronic data transfer
Basic typing skills
Excellent multi-tasking, prioritization, communication, and organizational skills and ability to work under stress
Ability to transfer and record data accurately, in the required format, and in a timely manner
Must be able to establish rapport and communicate with subjects of diverse cultural and…


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