Regulatory Coordinator/Data Coordinator-Medical Research Department

Troy, MI

$18-20, Contingent on experience

Looking for a full time regulatory coordinator/data coordinator in our Medical Research Department. Must possess excellent written and verbal communication skills. Must be self-motivated and a self-starter with excellent time management skills. Must be very detail oriented, have the ability to multi task and work well in a team environment. Strong computer skills needed to develop reports and documents/forms. Ability to communicate effectively with Physicians, Clinic employees and Sponsors. Responsibilities include working with pharmaceutical companies for study start-up & close-out activities, developing SOPs, maintaining study documents etc. College degree preferred but not required.

Full-time Hours: M-Th " 7 AM – 4:30 PM; F " 8 AM – 12 PM

Responsibilities:

· Handle sensitive information in a confidential manner

· Write and edit documents from letters to reports and instructional documents

· Develop and maintain filing systems, both electronic and physical

· Update and maintain office policies and procedures

· Work with supervisor to develop SOPs

· Take detailed meeting minutes during staff meetings

• Communicate effectively with subjects, research team, principal Investigators, ancillary staff, study sponsors and primary care providers.

· Work effectively independently as well as in a team environment.

· Assure all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.

· Prepare complex regulatory documents such as, Informed Consents, complex amendments, Progress Reports, Yearly renewal submissions.

• Maintain logs, including tracker submissions
• Participate in monitoring visits
• Participate in multidisciplinary team program meetings as required.
• Prepare for and participate in audits by sponsors and external regulators.
• Protect subject confidentiality.

· Audit charts

• Document and maintain all study related procedures and events on case report forms (CRFs) or electronic data capture (EDC),
• Respond to queries in a timely fashion.
• Participate in multidisciplinary team program meetings as required.
• Prepare for and participate in audits by sponsors and external regulators.
• Complete tasks and projects by deadlines set by supervisor & sponsors.
• Investigate solutions to problems and determines best course of action.
• Perform all other duties as assigned, which may include assisting in other departments within Troy Internal Medicine Research

REQUIREMENTS/QUALIFICATIONS

· Strong proficiency in MS Office Suite, including Word and Excel, Outlook or other email system, use of computerized medical tracking systems, internet search capabilities and other applications as appropriate.

· Excellent time management skills and the ability to prioritize work

· Attention to detail and problem solving skills

· Excellent written and verbal communication skills

· Strong organizational and planning skills with the ability to multi-task

Job Type: Full-time

Pay: $18.00 - $20.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Work setting:

• In-person

Ability to Relocate:

• Troy, MI 48098: Relocate before starting work (Required)

Work Location: In person