Clinical Trial Specialist
Proclinical is currently recruiting for a Clinical Trial Specialist for a biopharmaceutical company located in Cambridge, MA. Successful candidate will be responsible for study management and monitoring of assigned projects in accordance with SOPs, Good Clinical Practice, International Conference on Harmonisation (ICH) Harmonised Tripartite Guidelines, local regulations, and additional sponsor requirements.
- Demonstrate study and clinical investigative site management according to Good Clinical Practices, ICH Guidelines, local regulations, and SOPs.
- Create and provide input into study management requirements and tools, monitor tools and manuals and training tools.
- Maintain thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines.
- Perform study oversight and study site visits to ensure regulatory and study requirements are being fulfilled.
- Review study records including case report forms, consent forms, and other materials, and verse in remote monitoring approaches.
- Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols;
- Provide input, track progress, and work to implement corrective action plans for study and individual site recruitment and retention plans.
- Develop and maintain collaborative relationships with investigational sites study teams, CRO teams, and vendor teams.
- Produce quality and timely study documentation, including trip reports, tracking and site/sponsor communications in accordance with standard operating procedures.
- Maintain accurate and timely Sponsor/site communication and correspondence.
- Responsible for ensuring IMP and supplies accountability.
- Participate in company, departmental and project team meetings.
Skills and Requirements:
- Minimum of Bachelor's degree.
- Monitoring/CRO management or CRO oversight experience of clinical trials, including site management, or equivalent preferred.
- Knowledge of ICH GCP guidelines and the expertise to review and evaluate medical data.
- Excellent written and verbal communication, problem-solving, and interpersonal skills.
- Strong attention to detail.
- Effective organizational and time management skills.
- Ability to travel up to 35%.
- Proficient with MS Office Suite (Excel, Word, and PowerPoint), familiar with MS Project.
- Clear alignment with Core Values.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Maya Smith at (+1) 267-405-6995 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.