On Call Clinical Data Monitor I

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 On Call Clinical Data Monitor I, to lead and support our Clinical Pharmacology Start-up team in initiating Early Phase clinical trials for our clients with maximum speed and efficiency.

This is a on-call, office based position 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 Technicians are drawn to their 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.
• Act as principle host for sponsor CRF monitoring visits. Promoting a professional image
• of Leeds CRU and building strong collaborative working relationships with CRA’s.
• 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
• Educated to GCSE / O level standard.
• 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.
• Excellent written and oral communication skills
• Ability to prioritize workloads
• Good organizational skills
• Previous customer service experience desirable

Previous clinical experience is ideal, but not a must. We are open to consider recent graduates or any recent clinical experience.

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)