Clinical Research Coordinator I

Sansum Diabetes Research Institute•Santa Barbara, CA

1d•Onsite

About The Position

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. This position will fulfill 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 bloodborne pathogen precautions Recording 12-lead ECGs per protocol Providing ongoing patient education 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 sample storage 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

Requirements

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 educational backgrounds.
Interpersonal skills, public speaking, and report writing abilities
Ability to understand and carry out instructions in written, oral, or diagram form
Proven ability to deal with problems with several variables and ability to prioritize tasks and activities in a manner consistent with direction from supervisor
Ability to think and reason critically
Experience working in a medical setting
At least two years of experience working in clinical research
High school diploma and Bachelor’s degree or equivalent experience
The ability to read, write and speak English clearly is required.
The ability to interpret documents such as safety rules, SOPs, and procedures is critical and an understanding of and ability to communicate in scientific language is desired.

Nice To Haves

Scientific or nursing education desirable
Phlebotomy skills desired
ACRP CCRC certification highly desirable
Spanish proficiency and/or fluency desired.

Responsibilities

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
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 bloodborne pathogen precautions
Recording 12-lead ECGs per protocol
Providing ongoing patient education
Ordering outside laboratory tests and/or procedures on an as-needed basis
Centrifugation of blood samples
Processing and packaging of body fluid samples (including but not limited to blood, urine, and saliva)
Proper sample storage
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