Clinical Research Associate

Location
Burlingame, California, United States
Posted
Apr 06, 2021
Ref
4368338003
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
SUMMARY OF ROLE:

We have an exciting opportunity for an entry level Clinical Research Associate (CRA). The candidate will be part of the Clinical Affairs - Clinical Operations team and report into the Lead CRA for Clinical Operations. This person will play a key role in supporting the conduct of clinical studies for molecular in-vitro diagnostics (IVD). The CRA will conduct site monitoring visits as well as perform in-house CRA responsibilities. Success will lead to increased exposure to additional responsibilities and career development opportunities. On the job learning and a desire to say "yes" to new things are expected. This role will not be boring!

PRIMARY RESPONSIBILITIES:
  • Based on experience the candidate will conduct site co-monitoring or solo monitoring visits (pre-study, initiation, routine monitoring and closeout) per monitoring plan and applicable SOPs. Write comprehensive reports to reflect all activities executed during visits and maintain accurate and complete action item logs.
  • Site monitoring responsibilities will include assisting Sr CRAs and CTMs with training and overseeing cross-functional site personnel on study related procedures for the duration of the study. You will also have an opportunity to conduct refresher training for sites as required per clinical monitoring plan.
  • Assists with study start-up activities including but not limited to evaluation, selection, and activation of investigational sites for clinical studies.
  • Confirms qualifications of site and personnel, specifically the Investigator and Site Staff, as well as confirming suitable resources and facilities to properly conduct the study.
  • Tracks enrollment activities, maintain applicable spreadsheets for team collaboration, and develop contingency plans as needed, to ensure sites remain on track with enrollment commitments.
  • Extensive review of site Essential Documents (ED) within the Investigator Site File (ISF) for accuracy and completeness. Reconcile and ensure appropriate filing within the Trial Master File (TMF).
  • Escalates site issues to Sr CRAs and CTMs to ensure transparent and expedient communication between sites and study management.
  • Works with Sr CRA's to ensure Investigator Agreements (IA) and budgets are executed for assigned study sites.
  • Based on experience the candidate will assists Sr CRAs or perform solo source data verification of study data that has been entered into EDC, and expedites data cleaning process is performed to prepare data for adjudication and database locks.
  • Collaborates regularly with study lead and clinical study sites to ensure timely delivery of study milestones.
  • Assists with organizing IRB/EC submissions with follow through to ensure successful outcomes.
  • Participates in the drafting of additional study and department-related documents, including study newsletters, meeting minutes, and presentations.
  • Ability to travel up to 70%

QUALIFICATIONS:
  • Associates degree plus 4 years of job related experience; BS degree preferred
  • At least one (1) year of (CRA) monitoring experience in the pharma, IVD or CRO industry
  • Experience with clinical trial information systems
  • A thorough understanding of clinical processes as well as GCP and ICH guidelines,
  • Excellent communication, organizational skills, and attention to detail
  • Excited to 'wear many hats' and self-motivated to take on new challenges
  • Well organized and detail oriented

COMPENSATION AND CLASSIFICATION:
  • Classification: Full-time remote position (Midwest/West or East Coast)
  • Compensation: Competitive and commensurate with experience; includes equity package.
  • Benefits: Medical, dental, and vision; 401(k) and more

Inflammatix is an equal opportunity employer and does not discriminate on the basis of race, ancestry, color, religion, sex/gender (including gender identity), pregnancy, childbirth, related medical conditions and breastfeeding, national origin, age, sexual orientation, marital status, registered domestic partner status, military and veteran status, physical or mental disability, medical condition, genetic characteristic, or any other characteristic protected by applicable law.