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Clinical Research Coordinator

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Job Description

Job Summary

As an integral member of the APCaRI Registry and BioRepository, the Clinical Research Coordinator works in a dynamic, collaborative, quality-focused environment. Research staff interacts with technical, medical and management staff at the North and Southern Alberta Urology Clinics, in addition to Registry personnel and partnering hospitals. The role of the Clinical Research Coordinator provides an interesting and challenging opportunity to collaborate with investigators and the health care team to assume responsibility for the overall patient enrollment and coordination of clinical studies for the Alberta Prostate Cancer Research Initiative, APCaRI. The Clinical Research Coordinator will work primarily in the Alberta Urology Clinic/Prostate Cancer Centre. Studies include recruitment to the APCaRI Registry and BioRepository as well as Investigator initiated trials.

The Clinical Research Coordinator has overall responsibility for planning, executing, monitoring and controlling research activities related to APCaRI. Responsibilities include recruitment of study participants (e.g. identify and screen potential subjects, obtain informed consent); coordination of patient visit schedules as per study protocol; execution of all aspects of study visit (e.g. questionnaires, sample collection, including processing and shipment of samples according to clinical protocol), develops and maintains recordkeeping systems and procedures, provides clinical care for patients participating in clinical trials and the implementation and coordination of some aspects of data collection and source documentation, as per APCaRI SOPs and ICH/GCP guidelines.

Summary of Research

APCaRI team members are applying state-of-the-art genomic, proteomic, metabolomic and transcriptomic analyses to the development of new and better tests for prostate cancer. Clinical validation of these tests requires large numbers of high quality patient biosamples linked to accurate and complete clinical outcome data. Despite growing international efforts to improve biobanking, there is limited availability of high-quality biospecimens linked to well-annotated prospectively collected demographic and clinical information.

The APCaRI Prostate Cancer Registry and Biorepository is a province-wide comprehensive resource that incorporates all prostate cancer patients in Alberta. Biobanking samples from Albertan prostate cancer patients collected through the journey of diagnosis and treatment will translate into enormous benefits because it will lead to tests that are directly applicable to Albertans. Translation of these tests to the clinic within 5 years will have a considerable impact on patients and the healthcare system.

Requirements

  • BSc. or BScN. Combination of education and experience will be taken into consideration.
  • Recognized certification in clinical research (ACRP or SOCRA) obtained or plan to work towards
  • Minimum one (1) year clinical research experience in oncology with a strong knowledge base in GU Clinical Trials
  • Previous clinical research experience preferred
  • Autonomous clinical critical thinking ability
  • Training in ICH/GCP guidelines an asset
  • Certification in Phlebotomy an asset
  • NACTRC research course an asset
  • Knowledge of IATA shipping regulations and basic laboratory procedures an asset
  • Excellent organizational and time management skills required
  • Strong analytical and problem solving skills
  • Excellent interpersonal, verbal and written communication skills required
  • Ability to set priorities and work independently with accuracy in a d

Capabilities

  • Plan and coordinate the initiation of research study protocols
  • Participate in protocol management: review and adhere to multiple research protocols
  • Assist investigators with the preparation of documents for ethics submission (consents, protocols, study progress updates, adverse events reporting)
  • Reconcile research accounts; assist with accounts and prepare invoices for payment
  • Assemble study specific source documents and prepare study binders to ensure regulatory documentation is maintained to meet study requirements.
  • Provide instruction/teaching to study participants regarding study participation, protocol requirements, follow- up schedule, the use of data collection tools.
  • Help plan, implement, and maintain data collection and analysis systems in support of research protocols
  • Conduct patient follow-up, data collection, case report form (CRF) completion, study monitoring, data query resolution; promote patient’s adherence to the study and monitors patient safety in relation to study protocols
  • Identify, screen, recruit, instruct, and coordinate research subjects as appropriate to specific study objectives and work scope
  • Perform venipuncture to obtain blood samples, instruct patients to obtain urine and/or semen samples, request, process and store tissue samples according to standard SOPPs. Transfer samples to long-term storage facilities in a regular manner
  • Contribute to the development and maintenance of manuals, guidelines, SOPPs, Intake Surveys, and Quality of Life Questionnaires
  • Coordinate material inventory, requests and release
  • Coordinate the day-to-day activities of support staff engaged in the carrying out of research protocols
  • Monitor the progress of research activities; develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies
  • Develop and implement quality control processes throughout the conduct of the studies.
  • Provide ongoing written and oral reporting with the University Health Ethics Research Office (HERO) (when applicable), Northern Alberta Clinical Trials and Research Centre (NACTRC) (when applicable), and Human Research Ethics Board of Alberta (HREBA); investigators and industry sponsors (when applicable)
  • Work with investigators to notify departments regarding study termination/compliance; ensure appropriate retention of study files/materials
  • Sign confidentiality agreement and maintain participant confidentiality at all times.
  • Perform miscellaneous job-related duties as assigned including support for other programs related to APCaRI and/or site clinical research activities
  • Attend APCaRI conferences twice a year and some travel to Calgary is required

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