Precision Medicine Group

Clinical Research Associate II - FSP

Remote, United States · Mid

Sponsorship not specified$92k-$137kDetected 34 days ago

GCPProject ManagementEHR/EMRClinical TrialsClinical ResearchResearchCommunicationPublic SpeakingOrganizational Skills

About the role

The CRA II is a seasoned, experienced professional in monitoring and site management.
will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management.
Incumbents work independently as a study team member.

Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.

Minimum Required:
Site management or equivalent experience in clinical research
Ability to travel overnight.
Demonstrated ability to conduct formal presentations to a wide variety of audiences including, colleagues, investigative staff, and clients with a high level of proficiency
4-year college degree or equivalent experience in a scientific or healthcare discipline.
Two (2) years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research
Other Required:
Excellent communication and organizational skills are essential. A team player.
Experience monitoring oncology trials
Evidence of a client focused approach
Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.
Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed.
Fluency in English and for non-English speaking countries the local language of country where position based
Preferred:

Graduate or postgraduate degree
Auto-immune monitoring experience
Experience monitoring in rare and complex therapeutic areas
Experience monitoring EDC trials and EHR records
Experience in biopharma or relevant therapeutic area
Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country
Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines.

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.

Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.

This listing is sourced directly from Precision Medicine Group's careers page and normalized into a canonical job model.