Clinical Research Associate - FSP

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 client’s 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 LSAD 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 finalises 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 client’s 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 LSAD and CQAD.

• Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD 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 client’s 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 LSAD or line manage

Education, Qualifications, Skills and Experience

Essential

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).

• 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 client’s 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

•Valid driving license (*)- to be deleted if not required in a country.

(*) to be adapted to local country market needs

Desirable

• Ability to work in an environment of remote collaborators.

• Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.

• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

• Good analytical and problem-solving skills.

• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.

• Familiar with risk-based monitoring approach including remote monitoring.

• Good cultural awareness.

• Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.

• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

Key stakeholders and relationships

Internal (to client or team)

• LSADs and Local Study Teams

• Line Manager and local SMM LT

• Clinical Quality Associate Director

• Local Medical Teams: MSLs and Medical Affairs

• Global Study Teams

• Global Clinical Solutions functions

• Clinical Data Management

• Regulatory Affairs

• Patient Safety

External (to client)

• Investigators and site personnel

• Study related vendors

• Inspectors