We're looking for a Clinical Research Monitor(CRA), working in the Healthcare Systems & Services industry in Minneapolis, Minnesota, United States.
Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.
Develops and maintains liaison with clinical investigators, clinical research organizations (CRO), affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval.
Responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports.
May assist with design, development, and monitoring of clinical evaluation projects.
Trains investigators and site personnel.
Includes headquarter and field clinical research associates (CRA).
Implements and prepares the clinical development strategy as outlined by the clinical teams.
May contact and recommend qualified investigators to perform studies and initiate clinical trials.
Ensures recruitment and retention of patients.
Plans, executes and validates the centralized Risk-Based Monitoring processes for assigned programs in conformance with relevant regulations, guidelines, policies and procedures with general oversight.
Conduct centralized monitoring activities across the various phases of the trial associated with the study planning, start-up, execution, closeout, of clinical trials utilizing OC-RDC and CTMS (and additional electronic platforms as needed).
Provide input into the integrated centralized Risk-Based Monitoring plans, monitoring guidelines, and source data verification plans.
Compile historical site performance metrics and trending analysis.
Maintain oversight of key operational risk indicators (trial and site level); investigate and mitigate potential trial risks.
The pay range we are offering is 60 to 75 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
BA/BS degree in science or health care area or nursing degree, or equivalent education
5 years clinical trials monitoring experience; at least 3 years recent medical device monitoring experience
3 or more years of clinical trials monitoring experience required in the medical device or pharmaceutical industry, or CRO
Medical device experience is preferred
Previous experience as a clinical research monitor required, centralized monitoring is a plus
Good knowledge of overall clinical trial management, understanding of protocol, study associated risks and their significance
Critical thinking and analytical skills to define and analyze data from complex, overlapping domains to facilitate the key decisions
Good knowledge of the therapeutic area/medical device area being studied
Ability to operate and proactively use various systems and electronic databases to analyze trial quality/performance and compliance and pick up trends and early warning signals is required
Proficiency in Microsoft Excel
Effectively communicate and understand when issue escalation is required
Strong communication skills allowing smooth and effective communication along multiple communication streams required
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.