Clinical Research Coordinator II - Neurosciences

The Clinical Research Coordinator II will support Neurosciences research in a 1.0 FTE (40 hours/week) position, Monday - Friday, within standard business hours (some weekends may be required). This position will be based out the 490 Mississippi Building (primary location), with occasional travel to 200 University (secondary location), 205 University (secondary location), and outlying clinics, depending on Research Department needs.

The Neurosciences Research Program focuses on improving our understanding and care of neurological conditions. Under the direction of Dr. Mo Chen, PhD, Dr. Peter Kim, MD, and Dr. Timothy Feyma, MD, the Program designs studies to assess the quality, safety, and efficacy of neurology treatment and care at Gillette. Current areas of research include: assessing outcomes of surgical interventions and conducting clinical trials for rare and complex neurological conditions.

The Clinical Research Coordinator has significant responsibility and works to serve as an integral member of the clinical research team by leading research coordination for a designated clinical area, providing back-up to other areas as assigned. The person in this role acts as a liaison and communicator between clinicians, sponsoring agencies, Institutional Review Board (IRB), hospital departments/employees and patients to facilitate the start-up, implementation, coordination and close out of research projects. Level II will provide mentorship for Clinical Research Coordinators across the organization.

Compensation & Benefits Information:

The hourly wage for this opportunity is $29.82/hour to $44.73/hour, with a median wage of $37.27/hour. Pay is dependent on several factors including relevant work experience, education, certification & licensure, and internal equity. Hourly pay is just one part of the compensation package for employees. Gillette supports career progression and offers a competitive benefits package that includes a retirement savings match, tuition and certification reimbursement, paid time off, and health and wellness benefits for .5 FTE and above.

Core Responsibilities and Duties:

Study Management

• Organizes and facilitates study team meetings.
• Contributes to protocol development, helps determine protocol feasibility, and coordinates protocol approval processes. Recommends and implements protocol amendments as needed.
• Coordinates and establishes study schedule, clinical study activity assignments and allocation of staff and equipment.
• Develops and/or evaluates congruence of data collection tools (e.g. data dictionary, case report forms (CRF), electronic data capture (EDC) with the study protocol.
• Completes IRB application and amendments, continuing reviews, and other study related documents (consent, assent and HIPAA forms, patient recruitment materials, etc.).
• Leads screening and recruitment processes for study subjects.
• Leads consent and enrollment process when appropriate.
• Coordinates and manages study per protocol activities and carries out appropriate data collection systems and procedures.
• Conducts clinical study activity such as phlebotomy and specimen processing, vital signs, ECGs, height and weight, and other tasks as appropriately delegated by PI and record data and results.
• Serves as liaison to sponsors and outside agencies and collaborators as needed.
• Provides status updates/reports and manages monitor visits and required activities. Responsible for compiling and reporting protocol activity to study team and providing input and problem solving when needed.
• Facilitates and conducts close-outs and archiving activities.
• Works with Investigators on grant application(s) to ensure a smooth and timely submission.

Safety

• Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards.
• Oversees safety risks (e.g. clinical holds, product recalls) to minimize potential risks to subject safety.
• Informs the sponsor and IRB of any changes to the protocol or safety concerns and submit progress reports to the IRB per requirements.
• Ensures adverse event reporting is documented appropriately and maintains follow-up to determine AE resolution.
• Reviews common laboratory values and alerts.
• Maintains familiarity with and follows internal/external research guidelines/processes: Federal Drug Administration (FDA) Code of Federal Regulations, FDA guidelines, International Conference of Harmonization Good Clinical Practice (ICH GCP), IRB, National Institution of Health (NIH) and Gillette policies.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Pre and Post Award

• If applicable, works with Investigators on grant application(s) to ensure a smooth and timely submission.
• Maintains working knowledge of study contract and scope of work.
• Monitors, reconciles and requests corrections of study related subject visits to ensure that invoicing can accurately take place.
• Provides consultation to Research Financial Analyst regarding study related expenditures (i.e. study visits, participant reimbursement and time) for invoicing when applicable.
• Responsible for compiling and reporting protocol activity to study team.
• Communicates to Research Finance Analyst when study close-out needs to be conducted and consults in this process as needed.
• Develops accurate budgets in conjunction with Research Finance Analyst, PI and other appropriate Gillette staff tailored to specific funding sources (e.g. government, sponsors, internal).
• Obtains, negotiates and seeks approval of industry funded study budgets and contracts. Renegotiates budgets based on protocol changes when applicable.
• Facilitates site contract/subcontract/clinical trial agreement approval process by acting as liaison between Gillette and funding source.
• Will build Clinical Trial Management System (CTMS) templates for studies as well as use CTMS to monitor, reconcile and request corrections of study related subject visits and charges.

Qualifications:

Required

• High school diploma/GED
• Computer knowledge (use of all Microsoft products such as Access, Excel, PowerPoint, and Word)
• Ability to attend out-of-state meetings, as needed
• CPR certification (or within 3 months of hire)
• Certification in Clinical Research (ie. Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or comparable certification through Association of Clinical Research Professionals (ACRP) or similar organization or university.
  • OR must meet eligibility requirements to take the ACRP-CP® exam upon hire, and complete certification within 9 months of hire.
  • Familiarity with IRB process and federal and state compliance and regulatory rules pertaining to research, confidentiality, and HIPAA

 Preferred

• Knowledge of statistics to interpret and analyze clinical data
• Bachelors/Master’s degree in science or related medical field
• Able to perform height and weight measurements, vital signs, phlebotomy, ECG and carry out laboratory procedures

Knowledge, Skills and Abilities

• Good critical thinking skills
• Able to take initiative and perform job responsibilities at an independent level
• Able to communicate and facilitate a busy clinical research team with multiple clinical and research responsibilities.
• Strong attention to detail
• Excellent customer service skills
• Positive, encouraging attitude
• Capable of managing multiple projects
• Interest in continued learning regarding clinical area of research
• Familiarity with medical terminology

Gillette Children’s is committed to recruiting and retaining a diverse team, as we know that the diverse experiences of our employees make Gillette a stronger and better organization. We are committed to creating an equitable and inclusive environment where all patients, families and staff are welcomed and valued. We believe diverse perspectives and identities foster excellence, improve patient care and are essential for Gillette to fulfill its mission. Our team members collaborate to help patients of all backgrounds and abilities reach their full potential.

Gillette Children's is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of an individual's race, color, creed, sex, religion, national origin, age, disability, marital status, familial status, genetic information, status with regard to public assistance, sexual orientation or gender identity, military status or any other class protected by federal, state or local laws.

Gillette Children’s is a global beacon of care for patients with brain, bone and movement conditions that start in childhood. Our research, treatment and supportive technologies enable every child to lead a full life defined by their dreams, not their diagnoses.

To learn more about working at Gillette Children's, please visit https://www.gillettechildrens.org/careers.

Gillette Children's participates in the U.S. Department of Homeland Security (DHS) E-Verify program which is an internet-based employment eligibility verification system operated by the U.S. Citizenship and Immigration Services. If E-Verify cannot confirm that you are authorized to work, Gillette will give you written instructions and an opportunity to contact DHS or the Social Security Administration (SSA) to resolve the issue before Gillette takes any further action. Please visit https://www.e-verify.gov/ for further details regarding e-verify.

Salary : $30 - $45