Clinical Research Associate
- Experience Level
- Experienced (non-manager)
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.
- Communicate the progress and relevant information or escalate issues of the study to the appropriate study management team
- Engage and maintain good written and verbal communication with external stakeholders in order to ensure effective study
- Accountable for local activities required in set up and for high quality execution of studies; will seek 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
- 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 for clinical
- Works with client Study staff to carry out a local study / site level risk
- Delivers appropriate training to site staff and other relevant parties, as required. Assists with web based and face to face client trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively run the clinical study.
- Participate in global investigators and/or monitor meetings as appropriate. Facilitates investigator’s participation in global meetings and/or may assist the client 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
- Ensure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP).
- Work with the sites to ensure they address data queries in a timely Verifying that data entered in to the CRFs is consistent with patient medical notes and entered in real time.
- Ensure Investigator and site staff receives safety reports and new safety information in a timely manner.
- Ensure the accuracy of data collected for safety reporting (AEs, SAEs ), and provides such information to client safety department and other relevant departments, within the required time frames.
- Completes monitoring visit reports within the agreed
- Ensure local and global clinical study tracking databases are kept current with clinical study information as required (e. e-track, Veeva, RAMOS).
- Ensure all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the Ensure all unused study supplies are accounted for and destroyed appropriately.
- Ensure sponsor study records are inspection ready at all times and archives records as applicable.
- Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing
- Able to work within remote teams and independently
- Ability to effectively manage multiple priorities and responsibilities of increasing scope and
- Good interpersonal
- Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic
- Respects confidentiality in terms of
- Proactive, conscientious and precise in delivery of quality work even when under pressure
- Effective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timely
- Flexible with high learning and change agility
- Collaborative, building strong internal and external
- Knowledge of local regulations, IND/ICH GCP - guidelines,
- Available and willing to travel as job requires
- Strong computer skills with good eye for detail.
At 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.
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