Senior Clinical Research Associate

September 19

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Helping bring new therapies to light

Drug Development • Regulatory Affairs and Submissions • Clinical Strategy • Cell & Gene Therapy • Rare Diseases & Orphan Indications

1001 - 5000

Description

• Independently control and monitor investigational sites. • Pro-actively detect issues. • Provide solutions to ensure clinical studies are performed according to the trial protocol. • Comply with SOPs, applicable regulations, and principles of Good Clinical Practice. • Conduct site management in line with study budget. • Maintain and update CTMS in compliance with SOPs. • Liaise with project team members and track study progress. • Provide functional assistance to project team members. • Track collection of ongoing study data. • Supervise generation of electronic tracking systems and logs.

Requirements

• At least five years clinical monitoring experience and/or relevant clinical trial experience. • Relevant life science degree / medical / nursing background, or combination of education and experience. • Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures.. • Strong written and verbal communication skills including good command of English and local language. • Representative, outgoing and client focused. • Ability to work in a fast-paced challenging environment of a growing company. • Administrative excellence • Proficiency with various computer applications such as Word, Excel, and PowerPoint required. • Effective clinical monitoring skills (all kind of visits mastered): • Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology. • In-depth knowledge of clinical trials and the critical elements for success in clinical trials. • Excellent understanding of the drug development process. • Ability to proactively identify and resolve issues in a timely manner. • Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel. • Effective organizational and time management skills. • Ability to manage multiple projects and strong attention to detail. • Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients. • Ability to meet project requirements. • Proven flexibility and adaptability. • Ability to work in a team or independently and to effectively prioritize tasks. • Ability to perform travel an average of 8 days on site per month, depending on project needs.

Benefits

• Comprehensive benefits package per location • Competitive salaries per location • Departmental Study/Training Budget for furthering professional development • Flexible Working hours (within reason) • Opportunity for remote/hybrid* working depending on location • Leadership and mentoring opportunities • Participation in our Buddy Program as a new or existing employee • Internal growth opportunities and career progression • Financially rewarding internal employee referral program • Access to online soft-skills and technical training via GoodHabitz and internal platforms