CLINICIAN TO CRA PROGRAM

PPD is a leading global contract research organization (CRO) providing comprehensive, integrated drug development, laboratory, and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health! 

Are you an experienced clinician interested in transitioning your career into the CRO industry? Your expertise can make a valuable contribution to our home-based, traveling Clinical Research Associate (CRA) opportunities, supporting onsite clinical monitoring of ongoing studies.  

PPD has the global resources, formal training programs, and focused support available to fast track your career transition. Leverage your existing skills and our development tools for successful entry into an experienced CRA pathway.  

Along your new career journey, enhance your professional development by expanding your exposure to a vast array of therapeutic areas and innovative clinical trials. Advance further through the CRA career pathway when you are ready, at your own pace with flexible, regular promotion cycles throughout the year available for CRAs at PPD.

By applying here, you are expressing interest in our Clinician to CRA Program opportunities. Please review qualifications carefully – if you already have clinical monitoring experience, we invite you to explore our other experienced CRA postings.

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

QUALIFICATIONS

• Expertise in Oncology therapeutic area (comparable to at least 2 years).
• Registered Nursing certification or equivalent and relevant formal academic/vocational training.
• Comprehensive experience as a clinician in a healthcare environment (comparable to at least 5 years) that provides transferable knowledge, skills, and abilities to perform the job in a clinical research environment.

In some cases, the combination of education, training and experience provides the individual with the required knowledge, skills and abilities to do the job. 

KNOWLEDGE, SKILLS AND ABILITIES:  

• Ability to work in a team or independently as required
• Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload to meet changing project timelines
• _Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents _
• Good English language and grammar skills and proficient local language skills as needed
• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
• Self-motivated, positive attitude and good interpersonal skills

Working Environment:  

PPD values the health and well-being 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.

As a condition of employment with PPD, part of Thermo Fisher Scientific, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.

Our 4i Values:

            Integrity – Innovation – Intensity – Involvement

 If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!

#PPDHP

As the world’s leader in serving science, Thermo Fisher Scientific's professionals develop critical solutions—and build rewarding careers. They help customers in finding cures for cancer, protecting the environment, making sure food is safe, and so much more. When you #StartYourStory with Thermo Fisher, you are guaranteed meaningful work - both personally and professionally.