Clinical Trials And Projects Coordinator Jobs

4 plus years of experience in clinical trial management

Knowledge of the clinical trial process. Knowledge of ICH guidelines and GCP including basic understanding of regulatory requirements

Oversight and management of day-to-day trial operations including CRO management

Oversight and management of certain sub-studies that may be undertaken from time to time

Management of trials and oversight of day-to-day trial operations (70%)

Management of Study Team Members (15%)

Must possess good computer skills and organizational skills. Experience with an electronic document control and management system would be a plus.

Ensure timely and accurate entries and updates into a computer management system required for clinical conduct.

3 or more years of pharmaceutical related experience in medical writing, preferably in a CRO.

Thorough knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines.

Strong knowledge of medical terminology, clinical trials, and clinical research.

Strong knowledge of processes with a desire to promote improvement. Ability to motivate and energize others with a positive, can-do attitude.

Effective time management and organizational skills.

Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.

Equivalent combination of education, training and experience.

Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.

Knowledge of applicable protocol requirements as provided in company training.

3 years administrative support experience.

Ability to work in a fast-paced environment, have exceptional time management skills and to perform well under pressure

Experience working in a healthcare clinic setting is preferred

Demonstrates strong communication and interpersonal skills with clients

Providing support and leadership within our busy clinic

Managing incoming phone calls, emails and booking requests from clients in a timely fashion

Responding to client requests quickly and efficiently

Facilitates the redistribution of workload between Staffing Clerks.

Assists the Manager in preparing employee performance appraisals by providing objective and constructive feedback through formal and informal opportunities.

Employer paid vacation starting at 4 weeks (20 days)

Extended Health & Dental coverage

Ensures local unit procedures comply with departmental or Interior Health (IH) process and/or policy.

Recommends changes to departmental processes to meet department goals and objectives.

Minimum 5 years of combined experience in Medical Affairs/Clinical Operations/Clinical Development

Knowledge of the country’s healthcare system and market access environment

Plan and manage complex projects

Knowledge of clinical trial conduct

Previous experience in rare diseases is of advantage

Ensuring appropriate and compliant level of Patient Advocacy Organization (PAO) group involvement with Patient Advocacy team

Assist Clinical Research Coordinators in responding to data management queries, monitor findings and follow-up.

Accurately complete research tracking log & LMC Manager ad database

Identify appropriate study candidacy based on knowledge of each sites recruiting and upcoming clinical trials

Work on enrollment and retention initiatives with Manager, Operations and Director of Research

Assist the Director of Research, Manager, Operations and/or Investigators with any other research tasks as required

Perform accurate, complete and timely data entry of electronic or paper case report forms (CRF’s).

Facilitates the redistribution of workload between Staffing Clerks.

Assists the Manager in preparing employee performance appraisals by providing objective and constructive feedback through formal and informal opportunities.

Ensures local unit procedures comply with departmental or Interior Health (IH) process and/or policy.

Recommends changes to departmental processes to meet department goals and objectives.

Participates in department-wide process review to identify and implement technological solutions to improve efficiency and accuracy.

Has delegated responsibility for supervisory functions such as work assignment, leave requests, recruitment.

● Experience in a non-profit organization and/or knowledge and experience working with 2SLGBTQIA+ communities

● 2+ years of direct work experience in a project coordination and/or related/similar role

Interviews will be on a rolling basis

Submit Cover Letter & Curriculum Vitae to:

Project Implementation, Performance, and Assessment

● Point-person for all projects or programming that derives from approved government grant applications.

Knowledge of project management principles and methodologies.

Assess the clinical requirements of user groups by researching clinical benchmarks and best practices, and through operations analysis of service delivery.

Comprehensive knowledge of health care delivery systems.

Strong analytical, critical thinking and evaluation skills

Lead the planning and design of facilities for assigned clinical service initiatives; working with both internal and external stakeholders.

Prepare functional programs and assist the project team with facilities design decisions as they relate to clinical service delivery.

Systematic thinker with strong project management and organizational skills

Experience with modifying, implementing, validating, and maintaining a web-based Clinical Trials Management System, including trouble shooting operational problems

Experience with, or certification in Lean or Six Sigma considered an asset

Recognized certification in clinical research (ACRP or SOCRA) preferred

Minimum five (5) years clinical research experience in a health care setting

Minimum three (3) years cancer related experience

Intermediate computer experience: MS Word, MS Excel, MS PowerPoint, Outlook. Data management experience is desirable.

Minimum of four years clinical trial experience including site monitoring and project coordination responsibilities.

In-depth knowledge of clinical trial and drug development processes; ICH-GCP, FDA and TPD regulatory requirements.

Assists in the development and maintenance of project-specific databases to provide project status reports, historical data and fulfill regulatory requirements.

Demonstrated ability to manage multiple projects and cross-functional teams.

Well-developed interpersonal communication skills, both oral and written.

Facilitates the redistribution of workload between Staffing Clerks.

Assists the Manager in preparing employee performance appraisals by providing objective and constructive feedback through formal and informal opportunities.

A minimum of 5 years of experience with 3 years in scheduling, preferably in the healthcare field.

Ensures local unit procedures comply with departmental or Interior Health (IH) process and/or policy.

Recommends changes to departmental processes to meet department goals and objectives.

Participates in department-wide process review to identify and implement technological solutions to improve efficiency and accuracy.