DescriptionSHIFT: No Weekends
HCA Research Institute’s CardiovascularResearch has conducted over 180 industry-sponsored trials and enrolledmore than 2,000 patients since the program’s inception providing innovativeapproaches to clinical trial management.
Since 2007, thenetwork has grown to 11 hospital programs across the country working incollaboration with more than 125 physician investigators in multiplesub-specialties: interventional, electrophysiology, heart failure,cardiothoracic surgery, endovascular surgery, peripheral, and structural heart.
We offeryou a generous compensation package including: paid time off, 401k, medical,dental vision and life insurance.Summary ofyour Key Responsibilities:
- Supportsenrolling patients onto clinical trials through recruitment, screening,enrollment and follow up of eligible subjects according to protocolrequirements
- Responsible forworking with the principal investigator to meet or exceed study enrollment.
- Reviews thestudy design and inclusion/exclusion criteria with physician and patient
- Ensures theprotection of study patients by verifying informed consent procedures andadhering to protocol requirements/compliance
- Ensures theintegrity of the data submitted on Case Report Forms or other data collectiontools by careful source document review; monitors data for missing orimplausible data
- Ensures thatadequate and accurate records are maintained for inspecting
- Creates studyspecific tools for source documentation when not provided by sponsor
- Collects,completes, and enters data into study specific case report forms or electronicdata capture systems
- Generates andtracks drug shipments, device shipments, and supplies as needed
- Reports andfollows up on serious adverse events as necessary
- Implementsstudy-specific communications
- Ensures timelyadherence to protocol requirements
- Responsible forcompletion of all required documentation according to site works guidelines
- Ensures timelyand accurate data completion
- Maintainsaccurate 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 andreports adverse events, serious adverse events, protocol waivers, deviations,and violations
- Communicatesall protocol-related issues to appropriate study colleagues or manager
- Attends studyspecific on site meetings, investigator meetings, conference calls and monthlyCRC meetings as required or asked to do so
- Apprisesprincipal investigator, Research Operations Director and Regional Site Managerof all study specific medical issues for guidance
- Assists sponsor and US FDA audit teams
- Reviews and responds to anymonitoring and auditing findings and escalates issues defined by Regional SiteManager
- Maintains patientconfidentiality according to ethical and legal requirements
- Assists in providingcoverage for satellite clinic sites as necessary
- Responsible for coverageafter hours and on weekends as necessary
- Knowledge offederal regulations, good clinical practices (GCP)
- Knowledge ofmedical and research terminology
- Computer skillsincluding use of clinical trial database, electronic data capture, and MS Wordor Excel
- ExcellentVerbal and written communication skills
- Excellentinterpersonal skills
- The ability tocommunicate and work effectively with a diverse team of professionals
- Organizationaland prioritizing capabilities
- The ability towork independently in a fast pace environment with minimal supervision atoff-site facilities
This position requires an Associates Degree; Bachelor Degree is preferredExperience:
Yourexperience should include:
- At least one year of experience as a RN.
- At least on year of experience as a Clinical Research Coordinator preferred
- Cardiology research experience is preferred
Active Registered Nurse License
Do you want to be a part of a teamworking together to end cardiovascular disease? We look forward to speaking with youabout this phenomenal opportunity. Apply to hear more.
We are anequal opportunity employer and value diversity at our company. We do notdiscriminate on the basis of race, religion, color, national origin, gender,sexual orientation, age, marital status, veteran status, or disability status.