Clinical Research Associate
- Experience Level
- Experienced (non-manager)
The PRA, we know that our people are our greatest strength, so we work hard to hire the very best.
If you join our team, you can expected to be challenged, rewarded and nurtured.
We have a dynamic and loyal workforce, a culture that values individuality and innovation and an ongoing commitment to employee growth and development. The result? A dynamic and loyal workforce who take pride in the their work on clinical development which changes lives.
As a Clinical Research Associate, you will be dedicated to one of our global Pharmaceutical clients. As one of the world’s leading and most trusted healthcare companies they place their core values and commitment to scientific innovation are at the heart of everything they do.
- Communicates the progress and relevant information or escalate issues of the study to the appropriate study management team
- Engages and maintains good written and verbal communication with external stakeholders in order to ensure effective study execution
- Accountable for local activities required in set up and for high quality execution of studies; seeks managerial or other experienced support as appropriate
- Performs operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency and site close-out visits
- Performs site evaluation visits
- Determines the feasibility of the study protocol with reference to study complexity
- Confirms staff availability, suitable clinical facilities, potential for per protocol patient population
- Confirms ability to comply with ICH GCP and company requirements for clinical studies
- Works with study staff to carry out a local study / site level risk assessment
- Delivers appropriate training to site staff and other relevant parties, as required. Ensures that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively run the clinical study
- Participates in global investigators and/or monitor meetings as appropriate
- Facilitates investigator’s participation in global meetings and/or may assist the study staff with organizing local investigator meetings. Participates in other study meetings as required
- Maintain good relationship with sites and ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met
- Ensures that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP)
- Works with the sites to ensure they address data queries in a timely manner. Verifies that data entered in to the CRFs is consistent with patient medical notes and entered in real time
- Ensures Investigator and site staff receives safety reports and new safety information in a timely manner
- Ensures the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to safety department and other relevant departments, within the required time frames
- Completes monitoring visit reports within the agreed timelines
- Ensures local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track, Veeva, RAMOS)
- Ensures all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately
- Ensures sponsor study records are inspection ready at all times and archives records as applicable
Detail-orientated, passionate and reliable.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- Prior experience as a CRA working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
- A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
- You will be educated to degree level, have equivalent experience or be a licensed healthcare professional.
- Knowledge of filing and archiving trial documentation in the Trial Master File (TMF)
- Strong written and verbal communication skills in English and local language
Available and willing to travel as job requires
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
For more information please visit our website: www.prahs.com