Clinical Operations Lead

1 week ago

London, Ontario, Canada Alimentiv Full time

JOB TITLE:
Clinical Operations Lead

JOB LOCATION:
Canada

JOB SALARY:73, ,000 + Bonus

JOB REPORTS TO:
Manager, Monitoring & Site Management

JOB DEPARTMENT/UNIT NAME:
Monitoring & Site Management

JOB SUMMARY:

Responsible for the clinical operations of a project within a defined regional/global level.

Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.

The Clinical Operations Lead acts as a primary liaison between the CRAs and the clinical project team.

Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation, oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.

The Clinical Operations Lead will develop study tools for sites and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.


AREAS OF RESPONSIBILITY:

Project Oversight

  • Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.
  • Monitoring support visits (Comonitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.
  • Oversee regional startup and feasibility activities.
  • Assist in vendor management activities as required per project.
  • Perform review of visit reports for quality, compliance and appropriate site management.
  • Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.
  • Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.
  • Contribute to financial project management processes as applicable. May include but not be limited to input on revenue recognition, site payments, and site passthrough expense review.
  • May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.

Project Liaison

  • Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls
  • Provide operational support and guidance to the monitoring team throughout project.
  • Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.
  • First point of contact for regional CRAs for studyspecific questions and issues. Escalates to PM and other functions as appropriate.
  • Support line managers by providing status updates on utilization and performance of CRAs.
  • Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.
  • Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.

Study Documents and Plans

  • Develop training materials and study tools for sites and CRAs, including monitoring plans.
  • Develop and implement enrolment and recruitment strategies together with clinical project team.
  • Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.

QUALIFICATIONS:

WORKING CONDITIONS:

Office/home-based

  • Accommodations for job applicants with disabilities are available upon request.

  • Lead Optometrist

    1 week ago

    London, Ontario, Canada FYidoctors Full time

    FYidoctors London - Wharncliffe Road has an immediate need for a Full-Time Lead Optometrist with flexible hours Monday to Saturday.We are a state-of-the-art clinic with dedicated staff and a loyal patient base. Our well-established clinic has been serving patients in London for nearly 50 years and our team enjoy a great patient co-management relationship...

  • Lead Optometrist

    1 week ago

    London, Ontario, Canada FYidoctors Full time

    FYidoctors London - Wharncliffe Road has an immediate need for a Full-Time Lead Optometrist with flexible hours Monday to Saturday. We are a state-of-the-art clinic with dedicated staff and a loyal patient base. Our well-established clinic has been serving patients in London for nearly 50 years and our team enjoy a great patient co-management relationship...

  • Manager, Clinical

    1 week ago

    London, Ontario, Canada Victoria Hospital Full time

    Who We Are:London Health Sciences Centre (LHSC) is a world-class academic health sciences centre located in the southwestern Ontario city of London. Just two hours from Toronto and two hours from Detroit, London features a beautiful and walkable downtown core located on the Thames River, a vibrant culinary scene and scores of activities that highlight local...

  • Category Product Marketer-hybrid

    1 week ago

    London, Ontario, Canada Clinical Research Dental Full time

    We are looking for an enthusatsic, outgoing, marketing-savvy person to join our marketing team as our Category Product Marketer. This individual will focus on developing growth strategies and brand awareness across their assigned portfolio, while increasing market penetration, profitability and performance for each brand and product they represent. The...

  • Manager of Clinical Practice

    1 week ago

    London, Ontario, Canada Bayshore HealthCare Full time

    Manager of Clinical Practice - London BranchBayshore HealthCare is one of the Canada's leading providers of home and community health care services and is a privately owned company. Bayshore HealthCare is proud to showcase its achievement as a Platinum member of Canada's Best Managed Companies Program every year since 2006. In 2015, Bayshore achieved the...

  • Clinic Director

    1 week ago

    London, Ontario, Canada Lifemark Health Group Full time

    Clinic Director - pt Health - Old North Physiotherapy-Location: London, ONEmployment Status: Permanent Full-TimeThe Clinic Director is responsible for the leadership and success of the clinic. As Clinic Director, you will oversee clinical staff and patient services and will drive growth through business development activities.Qualifications:- Registered in...

  • Clinical Extern

    1 week ago

    London, Ontario, Canada St. Joseph's Health Care London Full time

    Posting # [ Non-Union ]Clinical Extern (Nursing) - 5 positionsExtern ProgramParkwood Institute Main - London, ONTemporary Regular Part TimeThis position is expected to end on March 31, 2025Through a patient and family-centered approach, the Clinical Extern (nursing) will work under the direct and/or indirect supervision of registered nursing staff, in...

  • Clinical Extern

    1 week ago

    London, Ontario, Canada St. Joseph's Health Care London Full time

    Through a patient and family-centered approach, the Clinical Extern Nurse will work under the direct and/or indirect supervision of registered nursing staff, in collaboration with the interdisciplinary team as an unregulated care provider, to promote and advocate for wellness while ensuring the delivery of holistic, high quality and safe care to...

  • Clinical Supervisor

    1 week ago

    London, Ontario, Canada ParaMed Home Health Care Full time

    Internet service providers may also use other standard web-based technologies to analyze the movements of you while accessing the Website. These technologies help the Extendicare Group ascertain the effectiveness of product and service campaigns and marketing programs, allow the Extendicare Group to customize the services offered on or through the Websites,...

  • Clinic Clerk, Otolaryngology Clinic

    1 week ago

    London, Ontario, Canada St. Joseph's Health Care London Full time

    An exciting opportunity exists for a casual clerk within the Otololaryngology, Head, Neck and Facial Plastic Surgery department of St. Joseph's Health Care, London. This unit specializes in the care of patients with various conditions but not limited to those requiring rhinolaryngoscopic procedures, biopsies, minor procedures, post op wound care, and...

  • Project Lead, Information Technology Services

    1 week ago

    London, Ontario, Canada St. Joseph's Health Care London Full time

    Posting # [ Non-Union ]Project Lead, Information Technology Services (ITS)Information Technology Services (ITS)St. Joseph's Hospital - London, ONFull TimeREPOSTEDThe Project Lead, IT is responsible for managing the implementation of strategic IT initiatives for St. Joseph's by providing overall project management including project governance, project...

  • Clinical Auditor and Practice Consultant

    1 week ago

    London, Ontario, Canada Home and Community Care Support Services Full time

    Job Description:Home and Community Care Support Services South West is seeking a Clinical Auditor and Practice ConsultantOpportunity Summary:The Clinical Auditor and Practice Consultant provides leadership in Professional Practice within Home and Community Care Support Services (HCCSS) South West. The role acts as a resource for internal and external health...

  • Manager, Clinical

    1 week ago

    London, Ontario, Canada Victoria Hospital Full time

    Who We Are:Who We AreLondon Health Sciences Centre (LHSC) is a world-class academic health sciences centre located in the southwestern Ontario city of London. Just two hours from Toronto and two hours from Detroit, London features a beautiful and walkable downtown core located on the Thames River, a vibrant culinary scene and scores of activities that...

  • Clinical Receptionist Assistant, Endoscopy Program

    1 week ago

    London, Ontario, Canada St. Joseph's Health Care London Full time

    Posting # [ Non-Union ]Clinical Receptionist Assistant, Endoscopy ProgramEndoscopy ProgramSt. Joseph's Hospital - London, ONFull TimeThe Clinical Receptionist Assistant in the Endoscopy Program will work closely with the healthcare team to support the everyday operations of the unit. The Clinical Receptionist Assistant focuses on patient care while...

  • Clinical Dietitian

    1 week ago

    London, Ontario, Canada University Hospital Full time

    Posting Period:Open: May 4, 2023Deadline: May 17, 2023Non-UnionDepartment Name:Clinical Dietitian - Bariatric Program UHAs a Registered Dietitian you will be responsible for the nutritional management of adult patients in the Bariatric Program at University Hospital. This position reports to Manager of Clinical Nutrition Practice for professional practice...

  • Clinical Receptionist Asst

    1 week ago

    London, Ontario, Canada St. Joseph's Health Care London Full time

    Posting # [ Non-Union ]Clinical Receptionist Asst.Diabetes and Endocrine ClinicSt. Joseph's Hospital - London, ONRegular Part TimeThis clinic is located within the Centre for Diabetes, Endocrinology and Metabolism. Working within an enthusiastic team striving to create a Centre of Excellence in Diabetes Care, the Clinical Receptionist Assistant (CRA)...

  • Clinical Receptionist Assistant, Family Medical

    1 week ago

    London, Ontario, Canada St. Joseph's Health Care London Full time

    Clinical Receptionist Assistant, Family Medical Centre:1 position Family Medical Centre Family Medical Centre London, ON CasualThe St. Joseph's Family Medical Centre was the first community based Family Medical Centre in Canada. It was founded in 1969 as a partnership with the University of Western Ontario, St. Joseph's Hospital, and the College of Family...

  • Clinical Receptionist Assistant, Ambulatory Surgery

    1 week ago

    London, Ontario, Canada St. Joseph's Health Care London Full time

    The Clinical Receptionist Assistant in the Ambulatory Surgery clinics will work closely with the Urology, Colposcopy and Otolaryngology - Head and Neck Surgery teams to support the everyday operations of each unit. The Clinical Receptionist Assistant enables improved patient flow and ensures continued quality for the unit.Essential Qualifications Knowledge...

  • Clinical Receptionist Assistant, Ambulatory Surgery

    1 week ago

    London, Ontario, Canada St. Joseph's Health Care London Full time

    The Clinical Receptionist Assistant in the Ambulatory Surgery clinics will work closely with the Urology, Colposcopy and Otolaryngology Head and Neck Surgery teams to support the everyday operations of each unit. The Clinical Receptionist Assistant enables improved patient flow and ensures continued quality for the unit.Essential Qualifications Knowledge of...

  • Clinical Receptionist Assistant, Family Medical

    1 week ago

    London, Ontario, Canada St. Joseph's Health Care London Full time

    The St. Joseph's Family Medical Centre was the first community based Family Medical Centre in Canada. It was founded in 1969 as a partnership with the University of Western Ontario, St. Joseph's Hospital, and the College of Family Physicians of Canada. The facility at 346 Platt's Lane has been in operation since 1985. The St. Joseph's Family Medical and...