Site Monitoring Lead – Clinical Trials Ridgefield, CT – REMOTE (EST AND CST APPLICANTS ONLY) 12 month W2 contract (with potential to extend or transition to perm) Pay rate: $85-90/hour About 25% travel Some of the Your Responsibilities: Trial Preparation:
- Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study.
- Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs working on assigned trials.
- Implement the monitoring plan as part of the Trial Team. Monitor clinical monitoring deliverables for assigned trials in clinical operations system(s)(e.g. BI CTMS).
- Deliver Risk-based Site Monitoring approach and local training for the trial.
- Develop and provide appropriate training of local trial teams (e.g. Clinical Trial Managers (CT Manager) and Clinical Research Associates (CRA)).
- Assist with in-house Site Monitoring inspection readiness activities and lead preparation for US site regulatory inspections, as requested.
- Behave as local expert and consultant on site management and monitoring topics.
- Participate in and contribute to global/regional and local Trial Team meetings, international/ regional / local Investigator Meetings.
- Timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee).
Trial Conduct:
- Monitor progress and oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct including adherence to ICH-GCP, and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans.
Including but not limited to:
- Issue management / oversight on country level.
- Continuous review, risk identification, evaluation/ analysis and communication on a country level as applicable.
- Maintain Risk-based Site Monitoring approach for the OPU and provide feedback on the trends identified that may impact the TLMM and/or site monitoring oversight plan.
- Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits) at OPU according to plan, implement follow-up actions and escalation, as required.
- In conjunction with SML-r, contribute to preparation and implementation of trial level documents including training material updates/retraining as needed.
- In conjunction with SML-r, facilitate communication and training related to site monitoring in the trial at the OPU:
- Communication and training of CT Managers and CRAs. Performing re- training as necessary.
- Participate, prepare input (as requested by SML-r) for Trial Oversight Meetings (country level) and contribute to the timely responses to questions from external and internal stakeholders.
Skills or Requirements:
- Oncology, Metabolic, CNS, and Dermatology experience
- Project Management. CAPA, Risk Assessment, Clinical Trial Monitoring
- PMP Certification
Education:
- Bachelor's Degree (Health Sciences, Health Care, Nursing or Others) required
- minimum of 5 years of experience performing on-site monitoring or 8 years of relevant business experience in the regulated pharmaceutical or healthcare industry, including on-site monitoring experience.
What's In It For You? We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
- Medical, Dental & Vision Benefits
- 401K Retirement Saving Plan
- Life & Disability Insurance
- Direct Deposit & weekly ePayroll
- Employee Discount Programs
- Referral Bonus Programs
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Visit to contact us if you are an individual with a disability and require accommodation in the application process.For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.