Clinical Research Coordinator

JOB DESCRIPTION
To work as an integral member of partner/investigator site staff maintaining the day-to-day relationship with a partner site/s involving planning, co-coordinating and, as appropriate, execution of clinical studies in accordance with the protocol, contracted scope of work and any relevant local guidelines and regulations.

RESPONSIBILITIES
- Work directly at patient/subject interface at investigator sites to deliver high quality patient data in accordance with local regulations, agreed scope of work and as required by protocol.
- Assist Investigator with Feasibility questionnaire completion and return.
- Facilitate timely start up of all studies at the site by ensuring timely completion/submission of regulatory documents and ethics approvals and IP release documents.
- Attend and participate in investigator meetings, monitoring visits, audits, seminars and other regional or national meetings.
- Assist with screening and enrollment of subjects into assigned studies.
- Support subjects on trials to encourage maximum retention and future recruitment.
- Assist with the establishment of a recruitment and contingency plan for each study.
- Perform functions necessary for successful completion of all protocol required visits/procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of investigational product, scheduling, drug accountability/reconciliation and organizational tasks, where appropriate and as delegated by the investigator, in accordance with local country requirements.
- Accurately complete source documents and case report forms in both paper and electronic format.
- Assist investigator with recording and reporting of adverse events as per local regulatory authority guidelines.
- Ensure documentation of data protection agreement is on file for assigned site (Nurse Honorary contract, Master CRC
Services Agreement or other such documentation) where necessary and in accordance with local country requirements.
- Perform other duties as assigned.
Qualifications

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good knowledge of medical terminology.
- Above average interpersonal and organizational skills.
- Proficient in the use of Microsoft Office.
- Fluent in local language, spoken and written.
- Fluent in written English language.
- Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
- Ability to maintain confidentiality.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
* Registered nurse, medical physician or appropriate educational qualification and 1 years experience as accepted