Coord Clinical Research- Cardiac - Richmond, VA - Henrico Doctors Hospital
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POST DATE 9/13/2016
END DATE 10/21/2016
JOB DESCRIPTIONAPPLY Job Code: 03058-3301
This position is located in Richmond, VA at Henrico Doctors Hospital.
It is a full-time position for Sarah Cannon focusing on our cardiac research work.
Hours are standard Mon-Fri.
Comprehensive benefits apply.
We are seeking those candidates with a nursing background (must). Research and/or cardiac experience is desired but not necessarily needed.
Duties include but are not limited to:
Supports enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements
Responsible for working with the principal investigator to meet or exceed study enrollment.
Reviews the study design and inclusion/exclusion criteria with physician and patient
Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements/compliance
Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data
Ensures that adequate and accurate records are maintained for inspecting
Creates study specific tools for source documentation when not provided by sponsor
Collects, completes, and enters data into study specific case report forms or electronic data capture systems
Generates and tracks drug shipments, device shipments, and supplies as needed
Reports and follows up on serious adverse events as necessary
Implements study-specific communications
Ensures timely adherence to protocol requirements
Responsible for completion of all required documentation according to site works guidelines
Ensures timely and accurate data completion
Maintains accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, drug dispensing logs, device utilization logs, subject logs and study-related communications
Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations
Communicates all protocol-related issues to appropriate study personnel or manager
Attends study specific on site meetings, investigator meetings, conference calls and monthly
CRC meetings as required or asked to do so
Apprises principal investigator, Research Operations Director and Regional Site Manager of all study specific medical issues for guidance
Assists sponsor and US FDA audit teams
Reviews and responds to any monitoring and auditing findings and escalates issues defined by Regional Site Manager
Maintains patient confidentiality according to ethical and legal requirements
Assists in providing coverage for satellite clinic sites as necessary
Responsible for coverage after hours and on weekends as necessary
Practices and adheres to the Code of Conduct philosophy and Mission and Value Statement
During your employment with SCRI you will be routinely assigned training requirements. You
are expected to complete any training assignments by the due date.
Medical and research terminology
Knowledge of federal regulations, good clinical practices (GCP)
Computer skills including use of clinical trial database, electronic data capture, and MS Word or
Verbal and written communication skills
Interpersonal skills, detailed -oriented and meticulous
Communicate and work effectively with a diverse team of professionals
Organizational and prioritizing capabilities
Work independently in a fast pace environment with minimal supervision at off-site facilities
High School Diploma
Bachelor s College Degree
Type of Experience-
Clinical experience- 1+ yrs.
Type of Experience-
Clinical research experience- 3 years
Appropriate education may be substituted for partial experience.
Certification or License:
RN or LPN
Research Professional Certification-CCRP or exam
Last Edited: 07/12/2016