Description
Essential Duties and Responsibilities:- Coordination and management of clinical trial sites
- Monitor via on site visits and via remote review of data collected: if the protocol is adhered to, if the study is performed in compliance with GCP, checks if IRB approvals are still valid and in place
- Review in time the eCRF data collection system on completeness and timely query resolution and closure
- Site management: build and maintain good relations with investigators and site staff
- Ensure that patient enrolment on site follows agreed recruitment plan
- Close down study centers on completion of the trial
- Ensure that study staff conducting the protocol has received the proper materials and instructions to enter patients into the study
- Ensure that the rights, well-being, and safety of human subjects are protected by verifying that informed consent procedures and protocol requirements are adhered to according to regulatory requirements
- Ensure data is submitted on Case Report Forms (CRFs) or other data collection tools
- Monitor data for missing or implausible data
- Maintain proper documentation of all site correspondence
- Assist in the training and mentoring of personnel
- Contact and troubleshoots non enrolling sites
- Perform monitoring and performs clinical closeouts in one or more programs
- Performs other related duties as required or assigned
- Bachelor's degree in Life Sciences (e.g., Biology, Nursing, Pharmacology)
- 2 + years site monitoring experience
- 3 + years experience working in Oncology (as a monitor, coordinator, or nurse)
- In-depth experience with each stage of a clinical trial (i.e. study start-up through archive) and study site management
- In-depth experience with each type of site monitoring visit (pre-study, initiation, interim, close-out)
- Thorough knowledge of FDA GCP-ICH Guidelines and local regulatory requirements
- Sound knowledge of medical terminology and clinical monitoring process
- Excellent verbal and written communications skills
- Excellent interpersonal and organizational skills and attention to detail
- Computer literacy, proficiency in MS Office
- Able to travel up to 50%
To find out more about Real please visit www.realstaffing.com