Job Description

Job Description

• Additional skills: Experience with data entry/query resolution using Medidata RAVE, has previous exp as a study coordinator in a clinic setting with direct interaction with patients and supporting clinic staff. Has experience managing all aspects of the study including performing study visits (collecting patient vitals, collecting AEs/SAEs)
• Part-Time hours are flexible the site only requires 24 hours per week and worker's schedule will be 3 (8 hour) days onsite each week.

Responsibilities:

• Perform clinical research support to investigators to prepare for and execute assigned research studies.
• 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 complex clinical research procedures including 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.

Required Knowledge, Skills and Abilities:

• 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.

Minimum Required Education and Experience:

• High school diploma 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.

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