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 different 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 follow:up on findings as applicable.
: Participates in investigator meetings as necessary. May help to identify 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 team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
: Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic c
