Clinical Research Coordinator I

Job Description

Job Description

Pay Range: $17.04hr - $22.04hr

Job Overview:

• The candidate will 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). The successful candidate will also assist with daily workload planning.

Responsibilities:

The candidate will 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.

Required Knowledge, Skills And Abilities:

• Knowledge of clinical trials and 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 (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.

Benefits:

Our Benefits Include:

• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities

Disclaimer : Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.

About Cynet Systems

Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.

As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.