TKL Research is a full-service, international Clinical Research Organization (CRO) serving the pharmaceutical, biotechnology, medical device and consumer healthcare industries. We provide comprehensive clinical trial management services for Phase 1-4 clinical research studies, including an inpatient Phase 1 facility and outpatient specialized research clinics.
We are seeking a highly motivated CRA for our growing organization!
As a Clinical Research Associate, you will take ownership of the monitoring functions on projects with proper planning, timely initiation and completion of high quality documentation, and work with our project management team to ensure that protocol requirements, deliverables and regulatory guidelines are met.
Responsibilities include, but are not limited to:
- Conducting clinical monitoring visits (ie, pre-study, initiation, interim and close-out) which includes all preparatory and follow-up aspects, with a range of travel at 50-75% (approximately 10 days per month, e.g. for assigned site visits, investigator meetings, co-monitoring)
- Attending weekly sponsor/project management teleconferences
- Involvement in initial review of study documents
- May present at Investigator's Meetings
- Monitoring site performance and compliance and providing management with necessary reports, updates, and recommendations
- Preparing clinical sites for regulatory agency audits
- Assisting sites and data management with data query resolution
Candidates must have 2+ years of proven success in monitoring clinical trials. Experience in Phase II and Phase III is a plus. A Bachelor's degree, preferably in a sciences or health related field is required. We seek clinical monitors who are highly organized and detail-oriented, computer literate, with strong problem solving abilities, and excellent written and verbal communication skills. Background in diverse therapeutic areas is preferred.
We offer a competitive compensation package for full time employees, commensurate with your background and experience, including full benefits, 401(k) with match and a profit sharing plan.
This is a remote-based position in Michigan or Illinois. Home office experience is required.
TKL Research, Inc. - 6 months ago