Advanced Clinical

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience, and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

REMOTE

We are hiring for the role of a Clinical Research Associate (CRA) responsible for the day to day activities of a including set up, monitoring and completion of clinical trials in accordance with SOPs, ICH-GCP, and relevant local and international regulatory guidelines.

Essential Functions/Responsibilities

• Ensures the integrity of clinical data and adherence to applicable regulatory, protocol and company guidelines.
• Ensures the rights, safety and well being of clinical trial subjects is maintained.
• Performs site monitoring activities including:
• site evaluation visits
• site initiation visits
• monitoring visits
• closeout visits
• Collaborates with the Clinical Trial Working Group (CTWG) to drive subject recruitment.
• Establishes and maintains regular contact with Investigators, vendors, and trial sites to ensure compliance with applicable regulations and the protocol.
• The job holder is responsible for maintaining cGxP knowledge applicable to the job.
• Assists in study feasibility analysis, country assessment, site identification and subject recruitment and planning.
• Co-ordinates local IRB/IEC submissions and any required local submissions with the Clinical Team Manager (as applicable).
• Assists in study start-up activities including site selection and document collection.
• Review of essential documents, including the local translation of essential documentation (e.g., Patient Information Leaflets).
• Coordinates study site payments where required.
• Liaises with CTWG to ensure all study requirements are arranged (e.g., central laboratory support, equipment)
• Provides training of clinical trial study staff at site initiation on all study procedures and throughout the duration of the study as required.
• Performs routine on-site monitoring visits including source data verification of CRF's, query resolution, essential document maintenance and IMP accountability as required per protocol.
• Ensures proper storage, dispensing, accountability, receipt and return of clinical study materials.
• Reviews adverse events reports and ensures site is reporting the events appropriately and in a timely manner.
• Ensures site compliance with trial protocols, ICH-GCP and applicable regulations.
• Works with site personnel and study team to prevent, address and resolve issues.
• Communicate project specific information to/from trial sites and documents communication with study site/project team and escalates issues to CTWG in a timely manner.
• Assists in development of enrolment strategies and recruitment plans with the CTM, providing information specific to each study site.
• Executes additional tasks to meet departmental project-related or developmental/change objectives.

Required Knowledge, Skills, and Abilities

• Knowledgeable of ICH-GCP, and relevant local and international regulatory guidelines, as applicable.
• Fluency in English and Spanish. For bilingual employees, perform simple translations (e.g., CRA/site communications), where applicable.
• Possess strong verbal and written communication, interpersonal and organisational skills.
• Have a high degree of accuracy and attention to detail.
• Ability to drive and be available for domestic and international travel including overnight stays, as required.
• Able to use initiative and problem solve.
• Flexible and adaptive approach to work.
• Able to work in a team and as an individual.
• Ability to identify issues and resolve appropriately with guidance.
• Ability to process visit reports and expenses claims in a timely manner to an acceptable, quality.

Required/Preferred Education and Licenses

• BSc (or equivalent) in a life science or healthcare discipline, pharmacy degree or nursing qualification AND a minimum of 3 years monitoring of clinical trials in the pharmaceutical/CRO or biotechnology industry.
• A minimum of 5 years’ experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry is required where no BSc or equivalent qualification is held.
• Competent with standard and job specific computer applications including Microsoft Office, SharePoint and Electronic Data Capture systems.
• Previous experience with risk-based monitoring approaches.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.