Monitors investigator sites with a risk-based monitoring approach; applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks
Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities
Assess investigational product through physical inventory and records review
Documents observations in reports and letters in a timely manner using approved business writing standards
Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution
Conducts monitoring tasks in accordance with the approved monitoring plan
Ensures a shared responsibility with other project team members on issues/findings resolution
Participates in investigator meetings as necessary
Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites
Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner

Requirements

Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 Months - 2 years as traveling clinical research associate)
Valid driver's license where applicable
Proven clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Ability to manage Risk Based Monitoring concepts and processes
Good oral and written communication skills, with the ability to communicate effectively with medical personnel
Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills

Benefits

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

clinical monitoringroot cause analysisdata accuracySDRSDVCRF reviewrisk-based monitoringmedical terminologyICH GCPadministrative tasks

critical thinkingproblem solvingcommunicationcollaborationinvestigationtime managementattention to detailreport writingissue resolutionteamwork

Bachelor's degree in life scienceRegistered Nursing certification