Molecular Technologist

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).

Job Responsibilities:

• 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 m.jacobs@proclinical.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.

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