Job details
Job type full-time
Full job description
Job title: clinical research associate i (cra 1)
Department: clinical research
Reports to: project manager and cra manager
Effective date:
Summary
The clinical research associate (cra) will be responsible for all necessary activities required for setting up and monitoring a study, completing accurate study status reports, and maintaining study documentation.
The cra will manage multiple aspects of subject’s welfare, including submission of protocol, consent documents for ethics/irb approval and assist in the preparation of regulatory submissions as requested.
To be successful in this role, the cra should be able to recognize logistical problems, and initiate appropriate solutionsIdeal candidates will be detail-oriented, have the ability to multitask and be able to collaborate with various role playersThe cra must be able to work independently, be a team player, and proactively problem solve.
As a cra you will work independently to monitor your study sites, including evaluation, initiation, routine and close out visits.
Qualifications
Minimum of 1 year of study experience as a cra, including at least 1 year of active independent field monitoring experience as a cra— all types of visits.
Bachelor`s degree in a life science or related discipline or rn/bsn with 4 years related experience.
Computer skills required with proficiency in microsoft office suite, including word, excel, powerpoint.
Other skills required:
Deep understanding of ich gcp guidelines, fda code of federal regulations, or local country clinical trial regulations.
Excellent time management and social skills
Highly motivated with a phenomenal eye for detail.
Duties and responsibilities
Implements and monitors the progress of clinical studies at investigative sites
Ensures that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (sops), ich-gcp, and all applicable regulatory requirements.
Conducts site visits to assess the qualification of potential investigators, sites, and site staff
Initiates studies and instructs site personnel on the proper conduct of studies
Conducts routine monitoring visits to oversee conduct of clinical trial and ensure principal investigator oversight
Provides regular clinical status information to team members and project management
Communicates common site trends to lead cra and other project team members
Performs investigative site file reconciliation and requests any new or updated site-related essential and non-essential documents
Reviews essential documents for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ich guidelines, project standard operating procedures, and sponsor requirements.
Ordering, tracking, and managing ip and trial materials.
Overseeing and documenting ip dispensing, inventory, and reconciliation.
Ordering, tracking, and managing ip and trial materials.
Overseeing and documenting ip dispensing, inventory, and reconciliation.
Meeting all deliverables including timely submission and finalization of monitoring visit reports, per sops and monitoring plan
Travel requirements: ability to travel up to 80% of the month
