Regulatory affairs associate Jobs in Whitby, ON

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Job Title : Clinical Research Coordinator 2

Duration : 6+ months

Location : Oshawa, ON

This position's starting pay is : $40.00 / hr.

Skills / Qualifications : Cardiovascular trial experience, Review Charts from Site Database; Visit Scheduling and Reminders; Update Study Portals; Patient Education; Upkeep Regulatory Binder; Maintain Study Supplies; Collect Patient Vital Signs; Perform EKG; Perform Protocol Mandated Visits; Patient Screening; Referral Management; Recruitment Activities; Patient Consent; Conduct Patient Visits

Part time hours : 24 / week; hours between 9am to 6pm; days TBD.

Summary :

Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and / or seeking enrolment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning.

Responsibilities :

• 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

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

About Us : SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.

Equal Opportunity Employer : SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.

Seniority level

Seniority level

Associate

Employment type

Employment type

Part-time

Job function

Job function

Research and Administrative

Industries

Pharmaceutical Manufacturing and Biotechnology Research

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