As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.Job DescriptionAs one of the largest Clinical Research Organizations in the world, we have four
EarlyPhase 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 DOYou 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)
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement.