Contract Clinical Research Jobs in Raleigh, NC (NOW HIRING)

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Work with a team to manage grants, contracts, and financial activities that support clinical research studies.

Be You.

This position will be located within the School of Medicine Shared Research Administration Resource Group and will play an active role in working with specifically identified departments to manage their portfolio of grants and contracts.

Pre-award activities include support for clinical research, including trials, for PI initiated and Sponsor initiated studies, for multiple clinical research programs.

• Ensure all applications and contracts meet sponsor/agency and university guidelines adhering to the necessary internal and external deadlines.

Post-award activities include detailed reconciliation of assigned project budgets, preparing complex budget reports, preparing adjustments and corrections in assigned project budgets for further review and approval in order to meet project goals and federal requirements.

You will effectively manage assigned projects and financial project portfolios using independent judgment and discretion to make decisions that impact the compliance and successful completion of the clinical research studies.

You will build and maintain close collaborative working relationships with the Principal Investigators (Pls), key study personnel and colleagues throughout Duke to effectively manage the financial activities of research studies.

This position is responsible for managing and overseeing an assigned portfolio of complex grants and contracts using knowledge of grant and contract management rules and regulations, technical expertise, and analytical skills.

Work Arrangement - Hybrid; This is not a remote position; Candidate needs to live within the Triangle/Piedmont Triad area.

DEPARTMENTAL PREFERENCES

Successful candidates will have previous clinical research administration experience and/or pre-award administrative and financial experience.

MINIMUM QUALIFICATIONS

Education/Training - Work requires communications, analytical and organizational skills generally acquired through completion of a bachelor's degree program. Research or grants education and/or certification is preferred.

• Successful completion of Financial Services Introduction to R3, Introduction to Duke GL, Introduction to Accounting, Sponsored Research Reporting, Research Administration at Duke (online), Basic Compliance (online), Duke Human Research Training (online), Budget Development and Negotiation Training, and Industry Funded Clinical Research-Process for Contracts within first six months of hire is required.
• Successful completion of the Research Administration Academy (RAA) is expected. Employees hired into this classification without RAA training will work closely with their manager to schedule and complete the training within 12 months of start date. The expectation is that the staff member will maintain the requirements for their level. Failing to meet these requirements will be addressed through the performance review process.

Upon successful completion of expected training, the employee must maintain certification(s) by completing continuing education requirements.

Experience - No experience required for candidates who possess a Bachelor's or Master's degree in a field of study directly related to the specific position.

Be Bold.

Skills

• Ability to analyze data and formulate conclusions.
• Ability to learn changing technologies related to grants and contracts management.
• Proficient use of computers; requires solid working knowledge of MS Office Suite (Word, Access, Excel, Power Point).
• Ability to communicate both verbally and in writing with all levels of the organization.
• Ability to manage and prioritize multiple projects/tasks simultaneously.
• Ability to create verbal and written reports.
• Knowledge of federal rules and regulations relating to research grant and/or contract activity.
• Knowledge of Duke University policies and procedures relating to grant and contracts activity.
• Knowledge of Duke University processes, systems and offices related to and/or involved in grant and contract submission and management.
• Understand and be able to apply federal and university rules to management of effort allocation for individuals compensated whole or in part from federal awards.
• Understand and be able to apply costing rules and regulations to federally funded projects.
• Experience with/Ability to perform required functions in SPS, R3, grants.duke and SES relating to assigned duties.
• Understand financial processes and controls including the reconciliation process.

Work Performed

Pre-award Job Responsibilities (90%)

• Develop budgets and budget justification in collaboration with PI/Research Team which include proofing the budget for inconsistencies, ensuring accuracy and compliance with study protocol.
• Arrange and participate in budget discussions.
• Prepare and submit grants and contracts through pre-award process utilizing both Sponsor and Duke regulations. Follow through to submission to Sponsor.
• Submit contracts through the SPS system for approval. Ensure receipt of sponsor signatures on final agreement.
• Advise the faculty/PI on administrative requirements in preparing proposal submissions.
• Assist faculty/PI and study team with development of internal cost assessment including the use/implementation of the Clinical Research Management System, if applicable.
• Obtain management approval on external and internal budgets before sending to the sponsor for review.
• If required prepare, coordinate and review proposal elements such as biosketches, justifications and facilities & resources for consistency, accuracy, and completeness.
• Monitor compliance with agency and University regulations regarding submission; verify all financial information, including the application of the appropriate overhead rate for the project.
• Negotiate budget and payment terms with the approval from the Principal Investigator, research team and Grants and Contracts Manager.
• Review informed consent to ensure it is consistent with the budget and financial terms outlined in the agreement.
• Interpret contractual payment terms and prepare final contract and associated budget and documents for initial invoice.

Post-award Job Responsibilities (5%)

• Read and develop a full understanding of the terms and conditions of the executed budget and payment schedule in order to set-up and effectively manage study finances.
• Manage the patient reimbursement process in a timely manner.
  
  • Monitor and determine appropriate charging of patient care expenses to the study fund codes.
  
  
• Promptly invoice, collect, deposit and record funds to the appropriate fund code according to the executed study budget and payment schedule for study start-up, ongoing per patient revenue, and all other earned invoice able payments.
  • Follow up as needed to ensure invoices are paid promptly.
  
  
• Manage overdrafts.
• Ensure that the Clinical Research Unit (CRU) Management Fee is transferred from study revenue to the applicable research infrastructure codes.
• Close-out studies in a timely manner in compliance with School of Medicine (SOM) policy and the requirements of the funding agency, as applicable.
  • Transfer any residuals in accordance with Departmental and School of Medicine (SOM) policy.
  
  
• Work closely with the study team to manage effort and make adjustments as needed to ensure that funding sources are properly aligned with the effort of faculty and study staff, while maintaining compliance with funding agencies policies.
• Monitor proposal and contract status and advise faculty/PI on requirements and deadlines associated with research protection protocols.
• Reconcile monthly budget reports and inform faculty/PI and/or supervisor of potential corrections/adjustments that have been made.
• Monitor compliance with agency and University regulations regarding reporting.
• Maintain financial records per the institutional documents' retention guidelines.

Administrative Job Responsibilities (5%)

• Produce reports and fiscal forecasts for the study team regularly during the study with enough detail for study teams to make informed decisions about their research portfolio, Hub accounts and funds available to support effort and other expenses.
• Develop project management plan for review by the faculty/PI or senior level grants administrator.
• Serve as primary liaison with sponsors, study personnel and PIs. Collaborate, and communicate with other study personnel as required.
  • Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions.
  • Refer more complex questions and escalate issues to others as appropriate.
  
  
  
  
• Interpret departmental policies and procedures, making decisions on specific operating problems and issuing instructions on behalf of unit.
• Apply federal and university rules to appropriately manage effort for individuals compensated, in whole or in part, from sponsored awards
• Submit reports to the Divisional Administrator/Business Manager/Leadership when requested.

Tier Structure

Associate: Proficient as a grants and contracts administrator.

Advanced: Experienced, highly capable, and requires minimal oversight of work. Experience - 3 years of relevant experience (2 years for internal employees who have received 2 Exceeds Expectations on performance reviews). Training - RAA required in addition to 2 electives to prepare for AGM is required. AGM must be completed within 12 months.

Senior: Subject matter expert. May be responsible for mentoring and developing others. Experience - 6 years of relevant experience (5 years for internal employees who have received 4 Exceeds Expectations on performance reviews. CRA certification can also reduce the years of experience requirement to 5 years). Training - RAA and AGM required. Expected to attend all the appropriate internal updates.

Lead: Advanced tier competencies as well as responsibilities for mentoring and developing staff. Oversees work of others. May or may not carry same responsibilities as a full supervisor. Experience - 3 years of relevant experience (2 years for internal employees who have received 2 Exceeds Expectations on performance reviews). Training - RAA and AGM required. Expected to attend all the appropriate internal updates.

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

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Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $59,829.00 to USD $96,900.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members.

Learn more at: https://hr.duke.edu/benefits/

Equal Opportunity Employer: Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions:
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Service