PPD is a leading global contract researchorganization. At PPD we are passionate,deliberate, and driven by our purpose - to improve health.
PPD’s Clinical Monitoring Team is made upof monitors with institutional knowledge, in-depththerapeutic experience, and robust operational tools to help clients define anddevelop clinical programs, minimize delays, and execute high-quality,cost-efficient clinical studies.
As a CRA, you will ensure the highestquality review of data and effective interaction with study sites. Our CRAsconduct on-site monitoring visits throughout the study to help our clientsdeliver life-changing therapies to patients.
Grow within the CRA careerpath to Sr CRA II or PCRA or develop into a line manager role. CRAs oftentransition to our client dedicated teams and to becoming CTMs working alongsideour Project Management team responsible for clinical deliverables on our studies.
At PPD we hire the best, developourselves and each other, and recognize the power of being one team. It's notjust talk - our award winning training programs speak for themselves.
Join PPD in our relentless pursuit of excellence- apply now!
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
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
At least 4 years of experience in global onsite clinical trial monitoring
Experience in global clinical trial audit or international regulatory inspection (e.g. US FDA) is preferred
Valid driver's license where applicable.
This role requires independent travel up to 50%, inclusive of traveling in automobiles, airplanes, and trains
Knowledge, Skills andAbilities :
Proven clinical monitoring skills
Demonstrated understanding of medical / therapeutic area knowledge and medical terminology
Demonstrated ability to attain and maintain a working knowledge of GCP's and applicable SOP's
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 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 ofour employees. We support and encourage individuals to create a healthy andbalanced environment where they can thrive.
Below is listed the working environment / requirements for this role :
Able tocommunicate, receive, and understand information and ideas with diverse groupsof people in a comprehensible and reasonable manner
Able towork upright and stationary for typical working hours.
Able towork in non-traditional work environments
Able touse and learn standard office equipment and technology with proficiency
Able toperform successfully under pressure while prioritizing and handling multipleprojects or activities
May haveexposure to potentially hazardous elements typically found in healthcare orlaboratory environments