Your tasks and responsibilities
The primary responsibilities of this role, Sr. Clinical Research Associate, are to:
Who you are
- Manage and oversee the Bayer Consumer Health (BCH) Personal Care Franchise the operational conduct of all types of Consumer Research Studies (e.g. Sensory Testing, testing of Consumer Commodities or devices, Consumer Care Insight Tests / Consumer Tests) in humans in which a subject is physically exposed to a BCH product or active product ingredient from obtaining bids working with sourcing to final study report.
- Works closely with Clinical Trial Manager on the preparation and conduct including monitoring of safety, efficacy and claims studies for Personal Care products. This includes amongst others the receipt of necessary documentation for the Trial Master Files (TMF) as well as TMF maintenance, control of budget, communication with and to Clinical Research Organizations (CROs), Laboratories, and other external vendors involved in the conduct of studies. Collection and maintenance of submission documents, including EC/IRB submissions.
- Operational expert for the set-up, preparation and conduct of Sensory Testing, testing of Consumer Commodities, Consumer Care Insight Tests / Consumer Tests in humans in which a subject is physically exposed to a BCH product or active product ingredient.
- Ensure that all applicable guidances including, however not limited to ICH Guidelines, GCP and SOPs are followed in all aspects of the studies.
- Partner with CRO data management staff to process Case Report Form (CRF) and subject reported outcome questionnaire development.
- Operational activities for the execution of efficacy, safety and claims studies for Personal Care Products, Oversee administrative activities, maintenance of study documentation, collection and review of IRB/EC submissions.
- Coordinating ethical committees/independent review board (EC/IRB).
- Perform study initiations, carry out interim monitoring visits with the timely completion of reports and oversee these activities conducted by internal and external CRAs and/or CROs.
- Ensure timely recruitment of subjects and smooth running of subsequent operations, including data flow.
- Account for and reconcile all used and unused trial supplies.
- Closing down or oversee closing down of study sites on completion of the trial including archiving study documentation and correspondence.
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following: Required Qualifications:
- Bachelor's or (international equivalent) in Nursing, Life Sciences, Health Sciences or other scientific/health- related field. Minimum of four years of experience in clinical biomedical development, preferably with 2-3 years in the field of clinical trial monitoring as a CRA.
- Ability to be On-Site in Morristown, NJ.
- Excellent written and verbal communication skills, interpersonal and organizational skills are preferred.
- Solid knowledge in in tracking clinical study costs against the budget.
- Knowledge of, and adherence to ICH/GCP Guidelines, and as well as appropriate guidelines for clinical monitoring are required.
- Knowledge and cross functional understanding of clinical trial methodology and logistics.
- Team player with ability to work independently to accomplish objectives within timelines established by the Clinical Trial Manager and /or Project Teams.
- Experience working in a matrix organization.
- Position requires willingness for business trips, up to 25%, partially with significant frequency.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Country:
United States Location:
A little about us:
Why Bayer? Because we’re a pioneer in the fields of human, animal, and plant health. Because we invent solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.