Research Regulatory Supervisor – Virtual Position Available In Mecklenburg, North Carolina

Job Description:

Position Description:

Every great life-changing discovery begins the same way-with newknowledge. It can change everything, from a single life to thefuture of entire communities. That’s why academic medicine, and thecontinuous pursuit of knowledge, is at the center of everything wedo at the Medical College of Wisconsin (MCW). In the role of aResearch Regulatory Supervisor you will be working in our CancerCenter.

PurposeSupervise regulatory personnel, and responsible foroverseeing daily operations, quality and timeliness of regulatoryactivities.

Primary Functions

• Supervise staff including overseeingdaily operations of the regulatory team to ensure compliance withstate and federal regulations.
• Develop, improve, and applystandard education, processes, and procedures requiring specializedexperience to assure timely, quality, and compliant work inconjunction with Regulatory CRQA Specialist and Regulatory Manager.
• Ensure creation and maintenance of accurate, timely and compliantregulatory records and data, providing information for evaluationand specific recommendations for improvement.
• Operationalize andimplement proposed solutions or process improvements related toidentified problems or obstacles in the system/procedures relatedto implementation of the research protocols.
• Draft, submit, andadvise on regulatory submissions including but not limited toprotocols, protocol summaries, amendments, protocol deviations,serious adverse and other reportable events, continuing progressreports, and consent-to-treat documents without need forsupervision.

Following IRB and IBC guidelines, prepare and/orprovide guidance to Regulatory Specialists for drafting/modifyingIRB and IBC documents or other safety committee and regulatorydocuments as required by research program activities.

• Keepabreast of changing regulations and regulatory techniques andmethodologies that might facilitate designated research projects.
• Demonstrate processes and procedures and provide individualizedinstruction for regulatory staff and other partners as required Perform as a regulatory specialist/coordinator for selectprojects as needed.

Maintain protocol activation timeline including trackingdeadlines for program components. Utilize MCW’s Clinical TrialManagement System (CTMS) OnCore and other system to assist withmeeting regulatory requirements and tracking activities. Collect,analyze, and disseminate program data. Report program data andprogress to program stakeholders Manage other data systems, such as Florence, RightFax, andeBridge which support research activities. Correspond with localand central IRBs as needed.

• Work closely with other teams anddepartments to advance the department’s research goals.

All remote work must be performed within one of the MCW registeredpayroll states, which currently includes: WI, AZ, FL, IL, IN, MD,MI, MN, MO, NC, TN,TX, and UTKnowledge – Skills – AbilitiesKnowledge of biology, chemistry, mathematics, documentation,regulatory compliance, interpretation of regulations, and recordsmanagement.

Oral and written communication skills.

Critical thinking,problem solving, and attention to detail.

Data utilization andresource management. #LI-AV1

Preferred Schedule:

Fulltime 8-4:30

Position Requirements:

SpecificationsAppropriate experience may be substituted foreducation on an equivalent basis

Minimum Required Education:

Bachelor’s degree

Minimum Required Experience:

5 years in complianceor healthcare field

Preferred Education:

Master’s degree in relatedfield

Preferred Experience:

Experience in a supervisor role

Certification:

CCRC or CCRP required. CITI training required within90 days of hire. Target salary range for this position is between $73,000.00 and$93,000.00 annually. The final offered salary will depend on theapplicant’s education, experience, skills, and knowledge, as wellas considerations of internal equity and market alignment. Why MCW? Outstanding Healthcare Coverage, including but not limited toHealth, Vision, and Dental. Along with Flexible Spendingoptions 403B Retirement Package Competitive Vacation and Paid Holidays offered Tuition Reimbursement Paid Parental Leave Pet Insurance On campus Fitness Facility, offering onsite classes. Additional discounted rates on items such as: Select cell phoneplans, local fitness facilities, Milwaukee recreation andentertainment etc. For a full list of positions see: For a briefoverview of our benefits see: MCW as an Equal Opportunity Employer and Commitment toNon-Discrimination The Medical College of Wisconsin (MCW) is an Equal OpportunityEmployer. We are committed to fostering a diverse community ofoutstanding faculty, staff, and students, as well as ensuring equaleducational opportunity, employment, and access to services,programs, and activities, without regard to an individual’s race,color, national origin, religion, age, disability, sex, genderidentity/expression, sexual orientation, marital status, pregnancy,predisposing genetic characteristic, or military status. Employees,students, applicants or other members of the MCW community(including but not limited to vendors, visitors, and guests) maynot be subjected to harassment that is prohibited by law or treatedadversely or retaliated against based upon a protectedcharacteristic. .