Clinical Research Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8btedn

Provide support to Clinical Affairs team to assure study site selection and conduct of the study by study sites in compliance with Good Clinical Practices, federal regulations, and Clinical Affairs SOPs through in-house and some on-site monitoring

Verifichi che le sue competenze e la sua esperienza corrispondano ai requisiti di questo ruolo, quindi si candidi con il suo CV qui sotto.

Conduct pre-study visits to assure the site has adequate facilities, staff, and subject population for conducting the study within established time frames

Coordinate the distribution of supplies to study sites and assure an adequate quantity of supplies on hand during the course of the study

Track distribution and return of all study materials and drug

Conduct site initiation in order to ensure that all elements are in place for performing the study according to protocol and in compliance with all applicable regulations and good clinical practice guidelines

Perform interim site monitoring visits and document findings in a monitoring report which will be completed in a timely manner

Perform close-out visits to all study sites

Assist in maintenance of Trial Master Files (TMFs)

Assist with preparation of informed consent (ICFs), case report forms (CRFs), study support documents for assigned studies

Review site generated ICFs for compliance with study protocol and federal regulations

Review and provide feedback to Clinical Trial Team Lead on data management documents





Review and provide feedback to Clinical Trial Team on pharmacovigilance plans for assigned studies

Evaluate and recommend selection of investigators/study sites

Train investigators, coordinator, and other trial staff in data collection methods to ensure collection of patient data that is accurate, complete, and conforms to project data standards and protocol requirements

Ensure the collection, review, and updating of all essential documents defined by FDA regulations, company industry standards

Job Experience: 2+ years of relevant working experience in a clinical research setting at a CRO

Or an R.N. or Bachelor's degree in biological sciences or other healthcare related field with/without related clinical research experience

Working knowledge of the FDA CFRs and Good Clinical Practice Guidelines associated with CRA activities

Must be proactive and able to work independently and with teams

Excellent written and verbal communication skills

Literacy in Microsoft Office (Word, Outlook, and Excel)

Ability and willingness to travel possibly up to 50% of the time

Oxford is an Equal Opportunity Employer. xkiyazw All applicants will receive consideration for employment without regard to race, ethnic origin, religion, sex, age, sexual orientation, gender identity, national origin, disability, or any other characteristic protected by law. All persons hired will be required to verify identity and eligibility to work in the Country in which they have applied to work.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8btedn