Clinical Research Coordinator, Cardiac- St. Petersburg, FL
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POST DATE 9/13/2016
END DATE 10/18/2016
Saint Petersburg, FL
JOB DESCRIPTIONJob Code: 03058-3381
SARAH CANNON RESEARCH INSTITUTE(SCRI) is the research arm of HCA's global cancer enterprise, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world's leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.
We believe our success is dependent on a healthy work environment where staff members are the core of advancing therapies for patients and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture.
SUMMARY OF KEY RESPONSIBILITIES:
Primary responsibility is to screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. Responsible for all data collection, source documentation, completing study specific case report forms, and submission of adverse experience reports.
DUTIES AND RESPONSIBILITIES:
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.
* Knowledge: A body of information needed to perform a tasks; May be obtained through education, training or experience
* Medical and research terminology
* Knowledge of federal regulations, good clinical practices (GCP)
* Skills:The proficiency to perform a certain task
* Computer skills including use of clinical trial database, electronic data capture, and MS Word or Excel
* Verbal and written communication skills
* Interpersonal skills, detailed -oriented and meticulous
* Abilities: An underlying, enduring trait useful for performing duties
* 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
Minimum Required: High School Diploma (GED)
Preferred: Bachelor s College Degree (4 yr program)
Clinical experience- 1+ yrs.
Clinical research experience- 3 years
* RN or LPN
* Research Professional Certification-CCRP or exam eligibility certification
Last Edited: 07/11/2016