Job Summary:

Reporting to the DRI Manager, the Clinical Research Coordinator (CRC) is responsible for gathering high-quality clinical research data and providing optimum medical care to patients in accordance with Health Canada standards. The CRC provides significant support to clinical research trials undertaken by DRI including: the coordination of patient recruitment and interviews including conducting research study suitability screening assessments; collection and management of clinical trial data; management of records, programs and resources; and maintenance of the databases and case record forms. The CRC will liaise with patients, physicians, nurses, administrative assistants, and pharmaceutical company representatives.

Duties:

· Plan, implement and oversee the delivery of high-quality clinical research trials including managing recruitment practices and interviews with potential participants; reviewing consent forms; performing phlebotomy and providing participants with medical care; keeping participants informed and educated about clinical trials; ongoing monitoring of participants; and referring participants for further clinical management as required

· Provide high-level research administration which may include developing research procedures, contributing to abstracts and manuscripts for presentation and/or publication, providing progress reports and other information to the ethics committee, funding bodies and other interested parties through the preparation of reports, delivery of presentations, and conducting briefing sessions

· Undertake trial visits; identify, collect, record, and analyze clinical trial data and prepare results for report and review by Principal Investigator (PI)

· Compile research reports and regulatory documents as required by protocol and research study/sponsor; ensure research information is timely, accurate, valid, meaningful, and to the sponsor's satisfaction, and that studies are run according to local and global regulations

· Liaise with and act as a conduit between the research team and other research trials stakeholders, including clinic, medical and other staff, pharmaceutical companies, and laboratories and diagnostic facilities for the provision of required equipment, data and services

· Contribute to and coordinate the planning, management and effective implementation of continuous improvement and quality assurance activities relating to recruitment, data collection and research practices and procedures

· Ensure that all research studies are conducted according to the most recent confidentiality principles, privacy laws and legal and regulatory bodies' protocols and guidelines

· Comply with all Occupational Health and Safety (OHS) instructions, policies and procedures and take steps to identify, eliminate and/or minimise OHS risks where appropriate

· Build and sustain relationships with an extensive network of internal and external stakeholders and use these to promulgate information about the research project(s) and engage with potential and existing research participants

Knowledge, Skills and Abilities:

Education: Post secondary Degree in a relevant health or science related field; master's degree preferred; equivalent combinations of relevant education, training and experience may be considered

Certification and/or equivalent experience/training in Phlebotomy/Venipuncture required

Society of Clinical Research Associates (SOCRA) Certification preferred

Experience:2 to 3 years demonstrated experience as a CRC or in a similar role supporting clinical research trials

Skills:

· Familiarity with clinical trial electronic case report form (eCRF) software

· Ability to adhere strictly to research protocols and guidelines whilst remaining up to date with clinical trial trends and developments

· Highly developed planning and organizational skills with experience establishing priorities, implementing improvements and meeting deadlines while working effectively under pressure

· Thorough understanding of human research ethics principles and familiarity with institutional ethics committee guidelines and Good Clinical Research Practice

· Demonstrated ability to work both independently and as an effective member of a team

· Ability to exercise high levels of independence, judgement and initiative

· Demonstrated understanding of confidentiality, privacy and information handling laws and principles; ability to work with sensitive information and maintain discretion at all times

· Highly developed interpersonal and communication skills with the ability to prepare professional documentation for various audiences and provide expert advice in areas of clinical or research knowledge

· Demonstrated relationship management skills, including the ability to interact with, negotiate and gain cooperation from internal and external stakeholders

Key Performance Indicators (KPIs):

1. Data Quality and Accuracy

· Goal: Ensure the timely and accurate collection and documentation of clinical trial data.

· Metric: Maintain a data accuracy rate of 98% or higher, with fewer than 2% of records requiring corrections after submission to the sponsor; ensure all required case report forms (CRFs) and trial data are submitted on time, with a goal of 100% compliance with submission deadlines.

2. Research Reporting and Documentation

· Goal: Ensure accurate and timely reporting of trial progress, results, and regulatory documentation.

· Metric: Submit all required reports and documentation (e.g., ethics committee progress reports, regulatory filings) by the assigned deadlines, achieving a 100% on-time submission rate.

3. Continuous Improvement and Quality Assurance

· Goal: Contribute to continuous improvement efforts by identifying opportunities for enhancing research practices and procedures.

· Metric: Identify and implement at least two improvements in clinical trial processes or patient recruitment strategies annually.

Work Environment:

· Clinical Research environment including exam rooms and office/desks

Physical Demands:

· Intense visual concentration is greater than 50% of the time (e.g. Computers and/or tablets)

· Requires extended periods of time sitting or standing