Experienced Clinical Research Associate (CRA II, Senior CRA, Principal CRA) - GOV

Submission for the position: Experienced Clinical Research Associate (CRA II, Senior CRA, Principal CRA) - GOV - (Job Number: 169516)

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD’s Government Clinical Monitoring Team is made up of monitors with institutional knowledge, in-depth therapeutic experience, and robust operational tools to help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

As a CRA, you will ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site monitoring visits throughout the study to help our clients deliver life-changing therapies to patients.

Grow within the CRA career path from CRA II to Sr CRA II or PCRA, even develop into a line manager role. CRAs often transition to our client dedicated teams and on to becoming CTMs working alongside our Project Management team responsible for clinical deliverables on our studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

Join PPD in our relentless pursuit of excellence - apply now!

Responsibilities:

Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification) 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, present potential solutions and follow all issues through to resolution Maintains 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 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. Manages the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial. 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 federal regulatory requirements/audits 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 member Other project work as assigned#LI-TH$

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD’s Government Clinical Monitoring Team is made up of monitors with institutional knowledge, in-depth therapeutic experience, and robust operational tools to help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

As a CRA, you will ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site monitoring visits throughout the study to help our clients deliver life-changing therapies to patients.

Grow within the CRA career path from CRA II to Sr CRA II or PCRA, even develop into a line manager role. CRAs often transition to our client dedicated teams and on to becoming CTMs working alongside our Project Management team responsible for clinical deliverables on our studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

Join PPD in our relentless pursuit of excellence - apply now!

Responsibilities:

Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification) 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, present potential solutions and follow all issues through to resolution Maintains 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 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. Manages the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial. 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 federal regulatory requirements/audits 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 member Other project work as assigned#LI-TH$

Qualifications:

Education and Experience:

Bachelor's degree in a life sciences related fieldor 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)

Valid driver's license where applicable

Preferred therapeutic experience: HIV/AIDS, Allergy/Asthma, Autoimmune or Transplant

Knowledge, Skills and Abilities:

Proven clinical monitoring skillsDemonstrated understanding of medical/therapeutic area knowledge and medical terminologyDemonstrated ability to attain and maintain a working knowledge of GCP's and applicable SOP'sGood oral and written communication skills, with the ability to communicate effectively with medical personnelAbility 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 required

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 60%, inclusive of traveling in automobiles, airplanes, and trains

Qualifications:

Education and Experience:

Bachelor's degree in a life sciences related fieldor 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)

Valid driver's license where applicable

Preferred therapeutic experience: HIV/AIDS, Allergy/Asthma, Autoimmune or Transplant

Knowledge, Skills and Abilities:

Proven clinical monitoring skillsDemonstrated understanding of medical/therapeutic area knowledge and medical terminologyDemonstrated ability to attain and maintain a working knowledge of GCP's and applicable SOP'sGood oral and written communication skills, with the ability to communicate effectively with medical personnelAbility 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 required

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 60%, inclusive of traveling in automobiles, airplanes, and trains

Submission for the position: Experienced Clinical Research Associate (CRA II, Senior CRA, Principal CRA) - GOV - (Job Number: 169516)