Clinical Research Associate

Job Description

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future!

A day in the Life:

• Communicate the progress and information or raise issues to the study management team.
• Accountable for activities required in set up and for quality execution of studies
• Performs site evaluation visits, study initiation visits, and monitoring visits at the frequency and site visits.
• Determines the feasibility of the study protocol with reference to study complexity.
• Confirms staff availability, facilities, for per protocol patient population.
• Confirms ability to align with ICH GCP and Client requirements for clinical studies and works with Client Study staff to carry out a study / site level risk assessment.
• Delivers training to site staff and parties, as the need arises. 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 be responsible for the study.
• Participate in global investigators and/or supervise meetings. Facilitates investigator’s participation in global meetings and/or may assist the Client study staff with organizing investigator meetings. Participates in study meetings as required.
• Maintain relationship with sites and ensure that study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related achievements are met.
• Ensure that investigators and staff fully understand their roles and responsibilities with respect to requirements (ICH-GCP).
• Work with the sites to ensure they address data queries in a timely manner. Verifying that data entered into 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 etc.), and provides such information to relevant departments, within the required time frames.
• Completes supervising visit reports within the agreed timelines.
• Ensure local and global clinical study tracking databases are kept current with clinical study information as required.
• Ensure all vital 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.
• Ensure sponsor study records are inspection ready at all times and archives records as applicable.

Experience and Skills

• Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing skills.

• Able to work within remote teams and independently.
• Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.
• Good interpersonal skills.
• Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment.
• Respects confidentiality.
• 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 manner.
• Flexible with high learning and change agility.
• Collaborative, building strong internal and external relationships.
• Knowledge of local regulations, IND/ICH GCP - guidelines.
• Available and willing to travel as job requires.
• Strong computer skills with good eye for detail.