Clinical Data Monitor I / Madison, WI (On-Site)

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 I, 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.