Proclinical is currently recruiting for a Molecular Technologist with a leading research company located in Spring House, PA. As the Molecular Technologist, you will contribute to monitoring plans using a risk-based approach (e.g. Risk Based Monitoring).
- Under supervision, participate in study center selection, pre-study qualification, initiation, and closeout.
- Coordinate and conduct study monitoring with CRAs to ensure study compliance, data quality, proper documentation and study completion.
- Review Essential Documents (e.g., Patient Informed Consent Forms, 1572s,)
- Help to develop framework for consistency in monitoring oversight across clinical programs.
- Review study protocol and study plans from an operational/monitoring perspective and provide meaningful and logical insights into its feasibility and appropriateness.
- Use study monitoring metrics to monitor recruitment, site visits, data quality, patient safety, timely submission of trip visit reports, timely escalation of any monitoring quality issues, etc.
- Contribute to development of patient recruitment strategies and identify barriers to recruitment and proposes solutions.
- Foster relationships with CRO study management and monitoring counterparts during all stages of study (start up, conduct, closeout, and query resolution/data cleanup).
- Oversees monitoring and study support team for quality and compliance. Identifies issues and escalates any areas of concern, including study conduct or personnel issues. Work with the CRO Clinical Lead/Lead CRA in managing communications and training for CRO CRAs. Leads, trains and helps develop contracted CRAs.
- Ensure consistency in processes across all programs and strict adherence to SOPs, regulations and guidelines.
- Serve as the face of company at monitoring oversight visits. Cultivate site relationships through discussions with PI and site staff. Address all study related questions.
- Oversee SSVs / SIVs / SMVs and COVs across programs as needed.
- Manage vendor activities for clinical studies ensuring that vendors are adhering to timelines, budget and are delivering quality.
Skills and Requirements:
- Bachelor degree in Life Sciences required, preferably in Biology or Chemistry
- Minimum of 2 years of experience in a lab setting required
- Minimum of 1 year of experience in a Molecular lab required
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 267-297-3376 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.