Title: Clinical Research Coordinator 2 Location:Scarborough, ON M1B 5N1 Duration: 11 months Part time role schedule: Three Days per wk, 24 hrs per wk, and the days are flexible (between Mon.- Thurs *no Fridays). Scope: 24 hours/week for 48 weeks.
What are the three most important qualifications?
Experience with: Day to day conduct & operations of clinical trials, phlebotomy, recruiting
Additional Skills Qualifications: The site would like assistance with conducting patient visits including administering and obtaining consent, recruitment assistance, handling and maintenance of study drug, data entry, EDC & query resolution, and would prefer someone with their Phlebotomy certificate who is also qualified to perform phlebotomy. Experience with IWRS would also be helpful.
Bilingual in any of the following South Asian languages HIGHLY preferred: Urdu (Pakistan), Tamil or Sinhala (Sri Lanka), Cantonese or Mandarin (China), or Hindi, Bengali, Marathi (India).
Description: 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 Preparation of lab 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 standardsA ssist with study data quality checking and query resolution. Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, vital signs, dose verification, 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 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. Phlebotomy experience and previous certification required. 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: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers a Group Registered Retirement Savings Plan (RRSP) Program to all eligible employees. Additionally, our employee discount program 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: $41.46/hr.
