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.
Skills:
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
Required Education And Experience:.
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.
Seniority level
Entry level
Employment type
Contract
Job function
Research, Analyst, and Information Technology
Industries
Information Technology & Services
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