Experienced Clinical Research Associate - Winnipeg Canada

Submission for the position: Experienced Clinical Research Associate - Winnipeg Canada - (Job Number: 176946)PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

As a PPD CRA, you will ensure the highest quality review of data and effective interaction with study sites.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on- site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites and client company personnel. Assists project manager or clinical team manager on assigned projects and will take a lead role where required. Supports the line manager to mentor, train and contribute to the development of junior clinical team members. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Functions:

Monitors investigator sites with particular ability to manage complex studies and/or challenging sites using a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable

Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM).

Supports Clinical Team Management, including or Clinical Manager of CRAs (CM-CRA), to mentor, train and contribute to the development of junior CRAs. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements, share potential solutions & implement where appropriate.

Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts

Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.

Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.

Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.

Responds to company, client and applicable regulatory requirements/audits/inspections.

Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

As a PPD CRA, you will ensure the highest quality review of data and effective interaction with study sites.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on- site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites and client company personnel. Assists project manager or clinical team manager on assigned projects and will take a lead role where required. Supports the line manager to mentor, train and contribute to the development of junior clinical team members. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Functions:

Monitors investigator sites with particular ability to manage complex studies and/or challenging sites using a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable

Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM).

Supports Clinical Team Management, including or Clinical Manager of CRAs (CM-CRA), to mentor, train and contribute to the development of junior CRAs. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements, share potential solutions & implement where appropriate.

Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts

Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.

Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.

Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.

Responds to company, client and applicable regulatory requirements/audits/inspections.

Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Education and Experience:

Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Considerable clinical research monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years) with a demonstrated high level of expertise in all aspects of clinical monitoring.

Valid driver's license where applicable.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

Expert clinical monitoring skills

Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents

Excellent critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving

Proficient in Risk Based Monitoring concepts and processes

Skills to mentor and train other monitors in a positive and effective manner

Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology

Excellent oral and written communication skills

Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues

Excellent interpersonal skills

Excellent organizational and time management skills

Strong attention to detail

Ability to remain flexible and adaptable in a wide range of scenarios

Excellent team player with team building skills

Effective presentation skills

Ability to work independently as required

Ability to utilize problem-solving techniques applicable to constantly changing environment

Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software

Good English language and grammar skills

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.Education and Experience:

Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Considerable clinical research monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years) with a demonstrated high level of expertise in all aspects of clinical monitoring.

Valid driver's license where applicable.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

Expert clinical monitoring skills

Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents

Excellent critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving

Proficient in Risk Based Monitoring concepts and processes

Skills to mentor and train other monitors in a positive and effective manner

Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology

Excellent oral and written communication skills

Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues

Excellent interpersonal skills

Excellent organizational and time management skills

Strong attention to detail

Ability to remain flexible and adaptable in a wide range of scenarios

Excellent team player with team building skills

Effective presentation skills

Ability to work independently as required

Ability to utilize problem-solving techniques applicable to constantly changing environment

Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software

Good English language and grammar skills

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.Submission for the position: Experienced Clinical Research Associate - Winnipeg Canada - (Job Number: 176946)