In-house CRA Job Description Template
Our company is looking for a In-house CRA to join our team.
Responsibilities:
- Assist in the development of study plans and status reports;
- Assist with development and review of Informed Consent Forms;
- Perform on site co-monitoring and remote monitoring activities;
- Perform regular reviews of data entered by investigational site staff according to data review/monitoring guidelines;
- Track study supplies and coordinate shipments of supplies to sites as needed;
- Manage the study Trial Master File (TMF) and ensure periodic TMF audits;
- Maintain the clinical trials management system (CTMS) and other project tracking tools;
- Collect, track and review investigational site records relating to subject screening and enrollment;
- Will coordinate work with CRAs monitoring on-site;
- Collect, track, and review all site regulatory documents;
- Interact with sites, clients, vendors and internal study team members.
Requirements:
- Ability to set priorities and work independently;
- Proficiency with office automation software including Microsoft Office and Adobe Acrobat and strong internet research skills;
- BA/BS, preferably in a life science, nursing, pharmacy or related field;
- The ability to constructively interact directly with sponsor personnel;
- Ability to travel as needed;
- 2 years of direct work experience managing essential documents within the CRO, pharmaceutical, or biotechnology industry;
- Attention to detail, excellent written and oral communications;
- Working knowledge of ICH E6, and the Code of Federal Regulations;
- Excellent organizational and multi-tasking skills;
- Strong written and verbal communication skills.