Virtual Experienced CRA Hiring Event – September 16, 2020 – West Coast – Late Phase

Submission for the position: Virtual Experienced CRA Hiring Event – September 16, 2020 – West Coast – Late Phase - (Job Number: 173345)PPD is hosting a Virtual Hiring Event for experienced Clinical Research Associates on Wednesday, 16 September 2020! If you have more than one year of experience as a traveling site monitor, we want to meet you! Join the members of our clinical management team for this opportunity and learn about the benefits of working for PPD. We have seen an exciting year of growth through our long-standing client partnerships, with particularly strong engagement in COVID-19 studies. We are experiencing continued demand for clinical talent to support our work. One of our largest hiring demands is for experienced CRAs, particularly in the US west coast region. This event will allow our leadership in Clinical Operations to engage with interested candidates.

On the day of the event, we will welcome you an opportunity to join a morning kickoff session with our North America Head of Clinical Operations, Daniel Jones. Following the kickoff session, virtual interviews will be conducted throughout the day via invitation only.

Please submit your application to this posting in order to receive follow up and additional information from the PPD Talent Acquisition team. You may also directly contact recruiter, Nick White, for more information: nicholas.white@ppdi.com. We know that meaningful results require not only the right approach but also the right people. We invite you to re imagine healthcare with us, working with a smart and energetic team!

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 perform and coordinate all aspects of the clinical monitoring and site management process.

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. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Functions:

Monitors investigator sites with 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.

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. Performs 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.

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).

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

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

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

Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.

Contributes to other project work and initiatives for process improvement, as required.

#PPDHP

*LI-OD1

IndeedPPDUS

IndeedPPDClin

PPD is hosting a Virtual Hiring Event for experienced Clinical Research Associates on Wednesday, 16 September 2020! If you have more than one year of experience as a traveling site monitor, we want to meet you! Join the members of our clinical management team for this opportunity and learn about the benefits of working for PPD. We have seen an exciting year of growth through our long-standing client partnerships, with particularly strong engagement in COVID-19 studies. We are experiencing continued demand for clinical talent to support our work. One of our largest hiring demands is for experienced CRAs, particularly in the US west coast region. This event will allow our leadership in Clinical Operations to engage with interested candidates.

On the day of the event, we will welcome you an opportunity to join a morning kickoff session with our North America Head of Clinical Operations, Daniel Jones. Following the kickoff session, virtual interviews will be conducted throughout the day via invitation only.

Please submit your application to this posting in order to receive follow up and additional information from the PPD Talent Acquisition team. You may also directly contact recruiter, Nick White, for more information: nicholas.white@ppdi.com. We know that meaningful results require not only the right approach but also the right people. We invite you to re imagine healthcare with us, working with a smart and energetic team!

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 perform and coordinate all aspects of the clinical monitoring and site management process.

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. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Functions:

Monitors investigator sites with 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.

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. Performs 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.

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).

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

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

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

Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.

Contributes to other project work and initiatives for process improvement, as required.

#PPDHP

*LI-OD1

IndeedPPDUS

IndeedPPDClin

Education and Experience:

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

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.

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:

Proven clinical monitoring skills Demonstrated understanding of medical/therapeutic area knowledge and medical terminology Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving Ability to manage Risk Based Monitoring concepts and processes Good oral and written communication skills, with the ability to communicate effectively with medical personnel Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues Good organizational and time management skills Effective interpersonal skills Attention to detail Ability to remain flexible and adaptable in a wide range of scenarios Ability to work in a team or independently as require Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software Good English language and grammar skills Good presentation 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 gamechangers - 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 sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.

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:

Proven clinical monitoring skills Demonstrated understanding of medical/therapeutic area knowledge and medical terminology Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving Ability to manage Risk Based Monitoring concepts and processes Good oral and written communication skills, with the ability to communicate effectively with medical personnel Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues Good organizational and time management skills Effective interpersonal skills Attention to detail Ability to remain flexible and adaptable in a wide range of scenarios Ability to work in a team or independently as require Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software Good English language and grammar skills Good presentation 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 gamechangers - 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.

US-WA-Seattle, US-CA-San Francisco-FSP2 San Francisco CA, US-CA-San Carlos, US-Nevada, US-CA-Los Angeles, US-CA-San Diego-San Diego CA Scranton Road, US-Washington, US-AZ-Phoenix, US-CA-San Francisco, US-CA-Foster City-FSP Foster City CA, US-WA-Seattle-FSP3 Seattle, WA, US-CA-San Diego, US-AZ-Tempe-Tempe AZ E Broadway Road, US-CA-San Diego-FSP San Diego, CA, US-WA-Bothell-FSP Bothell WA, US-WA-Seattle-FSP2 Seattle, US-AZ-Tempe, US-NV-Las Vegas-INV PPD DEVELOPMENT - LAS VEGAS, US-CA-Foster City, US-Colorado, US-WA-Bothell, US-CA-South San Francisco, US-NV-Las Vegas, US-Colorado-Denver, US-WA-Seattle-FSP Seattle WA, US-CA-San Carlos-FSP San Carlos CA, US-CA-South San Francisco-FSP San Francisco CA, US-Arizona, US-NV-Las Vegas-Las Vegas NVUS-WA-Seattle, US-CA-San Francisco-FSP2 San Francisco CA, US-CA-San Carlos, US-Nevada, US-CA-Los Angeles, US-CA-San Diego-San Diego CA Scranton Road, US-Washington, US-AZ-Phoenix, US-CA-San Francisco, US-CA-Foster City-FSP Foster City CA, US-WA-Seattle-FSP3 Seattle, WA, US-CA-San Diego, US-AZ-Tempe-Tempe AZ E Broadway Road, US-CA-San Diego-FSP San Diego, CA, US-WA-Bothell-FSP Bothell WA, US-WA-Seattle-FSP2 Seattle, US-AZ-Tempe, US-NV-Las Vegas-INV PPD DEVELOPMENT - LAS VEGAS, US-CA-Foster City, US-Colorado, US-WA-Bothell, US-CA-South San Francisco, US-NV-Las Vegas, US-Colorado-Denver, US-WA-Seattle-FSP Seattle WA, US-CA-San Carlos-FSP San Carlos CA, US-CA-South San Francisco-FSP San Francisco CA, US-Arizona, US-NV-Las Vegas-Las Vegas NVSubmission for the position: Virtual Experienced CRA Hiring Event – September 16, 2020 – West Coast – Late Phase - (Job Number: 173345)