Support clinical trial site feasibility and site selection process
Conduct all aspects of clinical monitoring for clinical trials including conduct of site qualification visits, site initiation visits, routine monitoring visits and close-out visits at clinical trial sites
Support the maintenance of the Investigator Site Files and sponsor Trial Master Files
Conduct all aspects of site management as prescribed in the clinical trial specific functional plans
Prepare accurate and timely trip visit reports
Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiates appropriate actions to achieve objectives
Organize and make presentations at Investigator Meetings
Participate in the development of Case Report Forms and clinical trial documents
Act as primary contact for clinical trial supplies and other suppliers (vendors)
Participate in regular clinical trial team meetings
Mentor less experienced or new CRA colleagues
Perform CTM tasks as appropriate and as delegated by the CTM
Proactively contributes to continuous improvement of Clinical Operation specific processes, procedure and templates

Requirements

Min. Bachelor’s Degree, preferably in life science or nursing, or equivalent
At least 4 years of on-site monitoring experience in the pharmaceutical/ biotechnology industry (incl. all monitoring visit types)
In-depth knowledge of ICH-GCP, FDA and EMA and applicable local regulations and laws
Understanding of basic medical oncology terminology and science preferable
Exceptional attention to detail
Advanced presentation and organizational skills
Comprehensive understanding of priorities within own scope with limited interaction with the supervisor
Proactively driving quality and efficiency to meet timelines and milestones in own scope
Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF, CTMS)

Benefits

Competitive rates for Health, Dental, and Vision Insurance
4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment.
Sick Time Off – 56 hours
12 Paid Holidays
100% Employer-Paid Life Insurance up to at 1x annual salary
100% Employer Paid Short- and Long-Term Disability Coverage
401(k) with Immediate Eligibility & company match… You are eligible for 401(k) plan participation as of your first paycheck. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
Partially paid Parental Leave for eligible employees. (3 weeks)
Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness
Employee Paid Identity Theft Protection and Pet Insurance.
Professional Growth: Opportunities to work with leading experts in the field of T-cell immunotherapy. Company provided learning and development opportunities Fast paced, high demand collaborative and dynamic environment.

Applicant Tracking System Keywords

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

Hard skills

clinical monitoringsite managementpatient recruitmentdata captureCase Report Forms developmentclinical trial documentationmonitoring visit typesattention to detailquality and efficiency improvement

Soft skills

organizational skillspresentation skillsmentoringproactive communicationteam collaboration