The primary function of the Clinical Research Coordinator is to coordinate the conduct of cardiovascular clinical research protocols in the in-hospital and clinic settings with an emphasis on the screening, enrollment, and monitoring of patient candidates/participants.
ESSENTIAL FUNCTIONS (ROLES AND RESPONSIBILITIES
Serves as primary study coordinator for research protocols at affiliated hospitals or in the outpatient clinic setting as assigned by Manager of Clinical Trial Operations.
Directs the conduct of clinical studies to ensure adherence to the research protocol and provides regular updates to Principal Investigator and Manager of Clinical Trial Operations on study progress.
Screens patient records, EMR, and physician referral summaries for identification of prospective candidates for research protocols.
Interviews prospective subjects for participation in clinical trials and obtains informed consent.
Participates in initiation visits/investigator’s meetings for assigned clinical trials (may involve travel) and implements these trials according to a deadline schedule mutually agreed upon by PI and sponsor.
Educates clinic/hospital personnel for participation in protocol conduct, data collection process, and related conceptual issues as applicable.
Maintains consistent enrollment in protocols and provides monthly written documentation of screening/enrollment/follow-up activities.
Coordinates the collection of data according to the research protocol, operations manual, and case report form guidelines within the budgetary guidelines established by Manager of Clinical Trial Operations and Principal Investigator.
Draws, prepares, and ships laboratory samples for clinical trials
Maintains investigational drug/device dispensing accountability and shipping logs according to protocol guidelines.
Perform EKGs and other procedures as directed by study protocol and delegated by Principal Investigator.
Instructs Principal Investigator/Sub-Investigator and other research personnel on procedures and tests that need to be performed in compliance with the study protocol and advises Principal Investigator on the results of procedures and tests; calling to attention findings of clinical importance.
Documents research related examinations, procedures, tests, phone calls and other activities in appropriate clinic or hospital charts.
Schedules follow-up visits for study patients in collaboration with Principal Investigator and provides source documentation for the activities conducted during these visits.
Completes accurate and complete data entry into case report forms or pre-established computer programmed formats ensuring appropriate source documentation.
Schedules and undergoes sponsor initiated monitor visits and quality assurance audits for periodic reviewing and querying of collected data in a timely fashion.
Other duties as assigned.
QUALIFICATIONS/REQUIREMENTS/COMPETENCIES
High school or GED required.
RN license preferred;
Minimum five (5) years of practical work experience acceptable in lieu of education.
Minimum of three (3) years of recent research experience, preferably in cardiology.
Proficient in word processing, computer spreadsheets, mainframe computer applications, and database management.
Computer knowledge required, electronic medical records (EMR) highly preferred.
Medical assistant knowledge preferred. Medical terminology a plus.
Must have excellent customer service skills.
Must be able to travel within main locations at SLHV.
Must be detailed oriented and able to multi-task.
Excellent oral and written communication skills.
Must be self-motivated individual.
Strong inter-personal skills.
Able to work independently with minimal guidance and as part of a team.
Ability to manage good relations on their bosses, fellow workers, and the participants.
Fluent in English, multilingual and American Sign Language (ASL) plus.
Work Environment
This position is a clinical position and will report to the office Monday- Friday from 6:30 am – 5:00 PM.
Physical Requirements
This position requires full range of body motion. While performing the duties of this job, the employee is regularly required to sit, walk, and stand; talk or hear, both in person and by telephone; use hands repetitively to handle or operate standard office equipment; reach with hands and arms; and lift up to 25 pounds.
Equal Employment Opportunity Statement
We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Salary and Benefits
Full-time, non-exempt position. Competitive compensation and benefits package to include 401K; a full suite of medical, dental, and ancillary benefits; paid time off, and much more.
The statements contained herein are intended to describe the general nature and level of work performed by the Clinical Research Coordinator, but is not a complete list of the responsibilities, duties, or skills required. Other duties may be assigned as business needs dictate. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.