Clinical Data Monitor (Part-time) / Madison, WI (On-site)

Fortrea•Madison, WI

1d•Onsite

About The Position

As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US. We are currently seeking a Clinical Data Monitor, to interact directly with our healthy volunteer participants while learning to read clinical research protocols and enjoy working in a fast-paced team-oriented environment. Each day is different, you will be exposed to a wide variety of Therapeutic Indications and study types (ascending dose, first-in-human, food effect, drug to drug interactions, etc.). This is a full-time, office/clinic-based job in Madison, WI. If you join us, you will work with some of the world´s leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug. Many are drawn to this profession because of its direct impact on patient care. If this is your case, you will not miss that working in Phase 1 trials. Whilst allowing you to have a close face-to-face relationship with participants, and as you continue to practice your clinical skills and knowledge, you´ll be involved with the latest medical technologies and treatments, witnessing their development firsthand. When the drug you worked with gets approved, you know you´ll touch many patient´s lives around the world.

Requirements

B.Sc. degree in Life Science / Pharmacy or equivalent related discipline is preferred
Must be able to demonstrate working knowledge of Microsoft Office.
Language Skills: English Required (Speaking, Writing, and Reading)
In lieu of education relevant job experience will be considered.
Typically looking for 1-2 years of data handling experience. Experience can be from a clinical or non-clinical background. For example, financial data handling background.
Comfortable working in an environment that is fast paced, has changing priorities, requires teamwork and people skills, and is technology based.

Responsibilities

Utilize skills, knowledge, and clinical judgment for all aspects of data capture, review and quality for Phase I studies.
Ensure that all data and information is produced on time, in accordance with defined quality standards and meets the requirements of the business and our customers.
Data Planning – responsible for all data aspects of studies including review of draft protocols, attending Clinic Start Up Meetings, supporting the workbook (CRF) design process, training plans for non-standard study data capture and attend Biometrics start up meetings as required.
Ensure that the data entry and QC of dose escalation data is completed within the required timelines.
Complete daily ongoing QC of all study data across Clinical Operations including daily shop floor QC.
Query Resolution – ensure all database queries; sponsors written data queries, CRA monitoring queries and internal QA audit findings are resolved within the agreed timelines.
Responsible for ensuring the weekly Data Entry Schedule is updated and accurately reflects study workload.
Study Close Down - Ensure completed CRF’s are signed by the Principal or Associate Investigator and that all CRF’s and source data is archived on completion of the study.
Perform other job-related duties and/or tasks as assigned.