Clinical Research Coordinator I

Cynet Systems is recruiting for a Clinical Research Coordinator I to support investigators in preparing and conducting clinical studies. The role involves coordinating study visits and procedures, collecting and maintaining research data, supporting subject safety, and helping ensure studies meet protocol and regulatory requirements.

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

Preferred

A BS would be a plus

Bachelor’s degree (preferred)

Benefits

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

Company

Staffing and recruiting services for North American companies

Sterling, Virginia, USA

http://www.cynetsystems.com/

Founded in 2010

1001-5000 employees

Qualifications

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

High school diploma

relevant work experience in a clinical environment or medical setting

equivalent combination of education, training and experience

Applicable certifications and licenses as required by the company, country, state, and/or other regulatory bodies

Relevant work experience in a clinical environment or medical setting

Equivalent combination of education, training and experience

A BS would be a plus

Required skills

Clinical Trials, Medical Terminology, Standard Operating Procedures (SOPs), Microsoft Windows, Microsoft Access, Microsoft Outlook, Microsoft Excel, Microsoft Word, Informed Consent Forms

Preferred skills

A BS would be a plus

Experience

Entry level