Clinical Research Coordinator - Cancer Institute at Memorial Regional Medical Center

Bon Secours Mercy Health • Midlothian, VA

1d

About The Position

To implement and manage aspects of all active clinical research programs and to assist in other activities as assigned by investigator providers related to these programs with responsibilities to include, but not limited to: interacting with BSHSI legal, finance, compliance, and other departments as appropriate to help start up new clinical trials. Handle consents and agreements, capture patient data and enter it into confidential data management systems provided by industry sponsors, handle regulatory (IRB) submissions for new clinical trials, submit Serious Adverse Event (SAE) information to IRBs, handle amendments, manage safety reports and submit to IRBs as appropriate, track annual review dates and submit continuing reviews, and assist with departmental needs as requested in a back-up capacity.

Requirements

• Bachelor’s degree in a health science, life science, or related field
• Minimum of 2 years of experience in regulatory affairs or clinical research
• Familiarity with regulatory and ethical requirements related to human subjects research (e.g., IRB, FDA, ICH-GCP)
• Strong attention to detail and organizational skills
• Excellent written and verbal communication
• Ability to manage multiple priorities and meet deadlines
• Critical thinking and problem-solving abilities
• Proficiency in Microsoft Office and familiarity with regulatory databases

Nice To Haves

• Master’s degree or regulatory certification (e.g., SOCRA, ACRP)
• Experience working in an academic medical center or large research institution
• Knowledge of electronic regulatory systems and clinical trial management systems (e.g., OnCore, REDCap)

Responsibilities

• interacting with BSHSI legal, finance, compliance, and other departments as appropriate to help start up new clinical trials
• Handle consents and agreements
• capture patient data and enter it into confidential data management systems provided by industry sponsors
• handle regulatory (IRB) submissions for new clinical trials
• submit Serious Adverse Event (SAE) information to IRBs
• handle amendments
• manage safety reports and submit to IRBs as appropriate
• track annual review dates and submit continuing reviews
• assist with departmental needs as requested in a back-up capacity

Benefits

• Competitive pay, incentives, referral bonuses and 403(b) with employer contributions (when eligible)
• Medical, dental, vision, prescription coverage, HSA/FSA options, life insurances, mental health resources and discounts
• Paid time off, parental and FMLA leave, short- and long-term disability, backup care for children and elders
• Tuition assistance, professional development and continuing education support
• Benefits may vary based on the market and employment status.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees