Research Nurse Ms Clinical Trials Jobs

Previous experience in research of a clinical nature preferred.

Nursing care knowledge related to clinical area.

Roles and responsibilities of members of the healthcare team.

Demonstrated effective oral and written communication skills.

Preference will be given to those applicants competent in an Indigenous language and/or knowledge in Indigenous customs, traditions and values.

Graduate from an approved School of Nursing.

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.

Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusion

Registered Nurse with BCCNP plus a minimum of one year of nursing experience.

Attentive to detail, with the ability to work quickly and accurately. Superior organizational skills.

Strong analytical, problem solving and decision-making skills.

This offer is conditional upon successful completion of a Criminal Record Check.

Obtain informed consent for study participants.

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.

Shares nursing knowledge with colleagues

Knowledge with Microsoft office required

Excellent interpersonal and communication skills—interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources

Reviews lab and ECG results

Collects vital signs and ECGs

Administers oral, intramuscular, subcutaneous, and intradermal medications

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).

A minimum of 8 years Scientific experience of project management.

Experience and hands on knowledge of analytical instrumentation (specifically LC-MS/MS).

Applying experience in serum/plasma and tissue sample extraction techniques.

A strong team player with excellent oral and written communication skills.

Skilled in data interpretation and report writing.

Demonstrating strong understanding of LC-MS/MS theory and applications.

Knowledge, Skills & Abilities Needed:

Ongoing training and line management support

Phlebotomy skills (Venepuncture) and handling, processing of blood.

Experience working with central venous access

Registered Nurse with research experience 

ICH-GCP (Good Clinical Practice) Certification -

Monitors the quality within the laboratory according to GLP, regulatory agencies requirements and internal SOPs.

College degree and/or University degree in Chemistry, Biochemistry or Immunology or equivalent field. Pertinent experience may be considered in lieu.

Based on training, responsible for daily in process quality control for batches ongoing in the lab.

Supports responses to QA reports.

Supports and mentors analysts in the daily laboratory documentation procedures and processes.

Can participate in basic training of laboratory staff.

Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusion

Phlebotomy skills /experience is preferred

Other skills necessary for this position include: computer experience including MS Office and Excel; REDCap experience is an asset

Provides education regarding participation in the study and participates in the informed consent process

Supports research participants’ understanding of the procedures, potential risks, and possible benefits inherent to their involvement in the study

Experience in the field of Reproductive Medicine and Women’s Health is be an asset

• Identity and Access Management

• Operations Management Suite (OMS)

• Recommend a solution that aligns with the customer’s business needs and requirements (discuss benefits and risks)

• Experience in Administration of MS Intune and SCCM along with good understanding in Cloud computing

• Should have good hands-on experience in Windows Auto-pilot deployment

• Knowledge and proficiency in Active Directory Domain Services (AD DS) and related technologies

Minimum of two (2) years of Pediatric experience required

Minimum of two (2) years of experience in Hematology/Oncology required

Experience in clinical research preferred

Hematology/Oncology certification or enrollment in certification process preferred

Demonstrates strong organizational, communication and interpersonal skills with patients, families and colleagues

Demonstrates ability to manage time, be organized, take initiative, complete tasks on time, and have high attention to detail

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.

Maintain a current knowledge of the study status and important milestones

2+ years of relevant experience within a university research setting, hospital, or comparable environment

Strong clinical skills including blood sampling, IM injections and physical assessment

Experience writing, editing, and reviewing study related documents

Excellent oral and written communication skills

Knowledge of Microsoft Office (Word, Excel)