INC Research has flagged the Senior CRA I (Taiwan, Taipei) job as unavailable. Let’s keep looking.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.

The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Local Study Manager.

Typical Accountabilities

  • Contributes to the selection of potential investigators.
  • In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
  • Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
  • Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
  • Actively participates in Local Study Team (LST) meetings.
  • Contributes to National Investigators meetings, as applicable.
  • Initiates, monitors and closes study sites in compliance with Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
  • Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
  • Updates CTMS and other systems with data from study sites as per required timelines.
  • Manages study supplies (ISF, etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
  • Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSM the correct timing and type of visits.
  • Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
  • Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
  • Ensures data query resolution in a timely manner.
  • Works with data management to ensure robust quality of the collected study data.
  • Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
  • Prepares and finalizes monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with SOP.
  • Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
  • Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required.
  • Assists site in maintaining inspection ready ISF.
  • Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSM and CQM.
  • Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, SOPs and local requirements. Supports/participates in regular QC checks performed by LSM or delegate.
  • Ensures that all study documents under their responsibility (i.e. site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
  • Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.

Ensures compliance with Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

  • Ensures compliance with local, national and regional legislation, as applicable.
  • Collaborates with local MSLs as directed by LSM or line manager.

Education, Qualifications, Skills and Experience

  • B.A./B.S. with strong emphasis in medical school.
  • At least 1 years' experience as CRA.
  • Direct site monitoring experience means full scope onsite monitoring activities in phase I-III global studies.
  • Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
  • Good knowledge of relevant local regulations.
  • Good medical knowledge and ability to learn relevant Therapeutic Areas.
  • Basic understanding of the drug development process.
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
  • Excellent attention to details.
  • Good written and verbal communication skills.
  • Good collaboration and interpersonal skills.
  • Good negotiation skills.
  • Ability to travel nationally/internationally as required.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement. 

Read Full Description
Confirmed 14 hours ago. Posted 30+ days ago.

Discover Similar Jobs

Suggested Articles