Summary: Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning.
location: Ocala, Florida
job type: Contract
salary: $34.00 - 36.50 per hour
work hours: 9 to 5
education: High School
- Provide clinical research support to investigators to prepare for and execute assigned research studies, including: Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data
- Attend all relevant study meetings; Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research
- Recruit and screen patients for clinical trials and maintain subject screening logs
- Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits
- Design and maintain source documentation based on protocol requirements; Schedule and execute study visits and perform study procedures
- Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness
- Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics
- Monitor subject safety and report adverse reactions to appropriate medical personnel
- Correspond with research subjects and troubleshoot study-related questions or issues
- Participate in huddles to confirm daily study tasks are assigned to team members and are executed to the expected standards
- Assist with study data quality checking and query resolution.
- Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring.
- Record, report and interpret study findings appropriately to develop a study-specific database.
- Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards.
- Provide training to new investigator site staff members on study-specific topics and requirements.
- Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
- Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies.
- Assist research site with coverage planning related to staffing and scheduling for research projects.
- High school diploma (A BS would be a plus) or educational equivalent and relevant work experience in a clinical environment or medical setting; or equivalent combination of education, training and experience Applicable certifications and licenses as required by the company, country, state, and/or other regulatory bodies.
- Knowledge of clinical trials In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
- Knowledge of medical terminology
- Skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word Excellent interpersonal skills
- Ability to pay close attention to detail
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.