Your primary responsibility is to screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. You are responsible for all data collection, source documentation, completing study specific case report forms, and submission of adverse experience reports.
Duties and Responsibilities:
Your duties and responsibilities include:
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 colleagues 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
Knowledge of federal regulations, good clinical practices (GCP)
Knowledge of medical and research terminology
Computer skills including use of clinical trial database, electronic data capture, and MS Word or Excel
Excellent Verbal and written communication skills
Excellent interpersonal skills
The ability to communicate and work effectively with a diverse team of professionals
Organizational and prioritizing capabilities
The ability to work independently in a fast pace environment with minimal supervision at off-site facilities
The position requires a high school diploma; Associate Degree is preferred.
Your experience should include:
At least one year of experience as a Clinical Research Coordinator
Cardiology research experience is preferred
Nursing experience is preferred
Additional Salary Information: We offer you an excellent total compensation package, including competitive salary, excellent benefit package and growth opportunities. We believe in our team and your ability to do excellent work with us. Your benefits include 401k, PTO medical, dental, flex spending, life, disability, tuition reimbursement, employee discount program, employee stock purchase program and student loan repayment. We would love to talk to you about this fantastic opportunity.
Internal Number: 26857-6360
About HCA Research Institute
Sarah Cannon/HCA Research Institute’s Cardiovascular Research has conducted over 180 industry-sponsored trials and enrolled more than 2,000 patients since the program’s inception providing innovative approaches to clinical trial management.
Since 2007, the network has grown to 11 hospital programs across the country working in collaboration with more than 125 physician investigators in multiple sub-specialties: interventional, electrophysiology, heart failure, cardiothoracic surgery, endovascular surgery, peripheral, and structural heart.