Clinical Research Coordinator 1
Spectraforce
Calgary, Alberta
22 days ago
Job Description
Job Title: Clinical Research Coordinator 1
Location: Calgary, AB, T2N 4Z
Duration: 06 Months
Part time role: The sponsor has approved 24 hours per week for 26 weeks however the site still needs to determine how many hours of support is needed and the worker's work schedule (what days onsite and times per day).
Additional Skills/Qualifications: Worker should have experience performing the following skills proficiently with very little oversight:
• Coordinate clinical research studies and maintain a safe study environment according to health and safety policies under the direction and delegation of the Principal Investigator
• Safeguard the well-being of subjects, act as a volunteer advocate, and address subject’s concerns while ensuring the highest quality-of-care practices
• Maintain up-to-date study protocols, case report forms (CRFs), Electronic Data Capture (EDC) systems, and other study documents
• Plan and coordinate logistical activity for study procedures according to the study protocol
• Perform clinical set-up and preparation for the study including labeling specimen collection tubes and containers, inventory of required supplies, and setting up or troubleshooting equipment and/or study issues
• Assist with data entry, data quality checking, and query resolution to ensure adherence to study protocol and quality control for content accuracy and completeness
• Assist in study enrollment by recruiting, screening, and orienting volunteers according to the study protocol
• Correct custody of study drug according to site standard operating procedures
• Perform a variety of complex clinical procedures on subjects including but not limited to vital signs, phlebotomy, etc.
• Collect, record, and report clinical data and findings appropriately in CRFs while collaborating with study investigator about study no-related adverse events and serious adverse events according to the study protocol
Coordinate with study monitor on study issues and effectively respond to monitor-initiated questions.
Summary:
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).
Assist with daily workload planning.
RESPONSIBILITIES
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.
Benefits: SPECTRAFORCE offers a Group Registered Retirement Savings Plan (RRSP) Program to all eligible employees. We also offer an Employee Assistance Program (EAP) and an employee discount program, which provides exclusive access to thousands of discounts on travel, entertainment, and more. SPECTRAFORCE offers unpaid leave as well as paid sick leave, paid holidays, and paid vacation as required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant based on race, national or ethnic origin, colour, religion, age, sex, sexual orientation, gender identity or expression, marital status, family status, genetic characteristics, disability, conviction for an offence for which a pardon has been granted or in respect of which a record suspension has been ordered, or any other prohibited grounds as identified by provincial or territorial law. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $35.00/hr.
Location: Calgary, AB, T2N 4Z
Duration: 06 Months
Part time role: The sponsor has approved 24 hours per week for 26 weeks however the site still needs to determine how many hours of support is needed and the worker's work schedule (what days onsite and times per day).
Hours per Day | 8 |
---|---|
Hours per Week | 24 |
Additional Skills/Qualifications: Worker should have experience performing the following skills proficiently with very little oversight:
• Coordinate clinical research studies and maintain a safe study environment according to health and safety policies under the direction and delegation of the Principal Investigator
• Safeguard the well-being of subjects, act as a volunteer advocate, and address subject’s concerns while ensuring the highest quality-of-care practices
• Maintain up-to-date study protocols, case report forms (CRFs), Electronic Data Capture (EDC) systems, and other study documents
• Plan and coordinate logistical activity for study procedures according to the study protocol
• Perform clinical set-up and preparation for the study including labeling specimen collection tubes and containers, inventory of required supplies, and setting up or troubleshooting equipment and/or study issues
• Assist with data entry, data quality checking, and query resolution to ensure adherence to study protocol and quality control for content accuracy and completeness
• Assist in study enrollment by recruiting, screening, and orienting volunteers according to the study protocol
• Correct custody of study drug according to site standard operating procedures
• Perform a variety of complex clinical procedures on subjects including but not limited to vital signs, phlebotomy, etc.
• Collect, record, and report clinical data and findings appropriately in CRFs while collaborating with study investigator about study no-related adverse events and serious adverse events according to the study protocol
Coordinate with study monitor on study issues and effectively respond to monitor-initiated questions.
Summary:
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).
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
- 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 (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
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.
Benefits: SPECTRAFORCE offers a Group Registered Retirement Savings Plan (RRSP) Program to all eligible employees. We also offer an Employee Assistance Program (EAP) and an employee discount program, which provides exclusive access to thousands of discounts on travel, entertainment, and more. SPECTRAFORCE offers unpaid leave as well as paid sick leave, paid holidays, and paid vacation as required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant based on race, national or ethnic origin, colour, religion, age, sex, sexual orientation, gender identity or expression, marital status, family status, genetic characteristics, disability, conviction for an offence for which a pardon has been granted or in respect of which a record suspension has been ordered, or any other prohibited grounds as identified by provincial or territorial law. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $35.00/hr.