Clinical Data Monitor Madison Wi

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 (Part-Time)** 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. WHAT YOU WILL DO: You will utilize your skills, knowledge, and clinical judgement for all aspects of data capture, review and quality for Phase I studies. The Clinical Data Monitor I is someone who ensures 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. **Other key responsibilities**: * 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. * And perform other job-related duties and or tasks as assigned. **YOU NEED TO BRING…** * 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. The important thing for us is you are comfortable working in an environment that is: * **Fast paced**: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. * **Changing priorities constantly** asking you to prioritize and adapt on the spot. * **Teamwork** and **people skills** are essential for the study to run smoothly. * **Technology based**. We collect our data directly into an electronic environment. **What do you get?** Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: * Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) * 401(K) * Paid time off (PTO) * Employee recognition awards * Multiple ERG’s (employee resource groups) **_Physical Requirements:_** * _Ability to work in an upright and /or stationary position for 6-8 hours per day._ * _Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment._ * _Occasional crouching, stooping, with frequent bending and twisting of upper body and neck._ * _Ability to access and use a variety of computer software developed both in-house and off-the-shelf._ * _Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs._ * _Regular and consistent attendance._ * _Varied hours may be required._ Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).