Karen L. Grace

Responsible to the Research Practice Manager (RPM) for oversight of study conduct for oncology pan-therapeutic research studies within the Duke Cancer Institute Wake County Community Research Program. As ARPM, responsible for portfolio oversight and CRNC study duties across the Wake County pan-therapeutic community program: GI, GU, GYN, Breast, Hematology, Thoracic, Head and Neck, and Melanoma cancer research areas.

• Day to day management of CRU operations, ensuring that clinical research professionals and investigators are appropriately trained and performing activities in accordance with good clinical practice, CRU standards, institutional policy, and regulatory requirements and resources are managed to achieve the CRU and program goals
• Provide operational and study conduct metrics/reports to RPM, faculty, staff and executive stakeholders
• Screens, interviews, and hires clinical research professionals
• Conduct onboarding, training, and professional guidance for clinical research professionals, including navigation through the Tier Advancement process
• Manage staff effort distribution to ensure that staff are appropriately assigned studies based on volume and individual staff competency
• Conducts annual performance evaluations and performance improvement plans with staff; consulting with Human Resource Manager and RPM if needed
• Supervises and provides guidance on research operations of studies across oncology pan-therapeutic areas regarding adherence to regulatory and institutional policies and processes, screening, recruitment and retention, study monitoring, audit visits, participant and study level documentation, study visits, SOPs, specimen management, IND/IDE/ITP documentation, investigational product, and contracts and agreements
• Provides clinical trials support through nursing competencies across multiple oncology disease groups including: GU, GI, GYN, Breast, Thoracic, Head and Neck, Melanoma, and Hematology cancer populations
• Plan, provide, supervise and document professional nursing care utilizing professional nursing judgment and the nursing process for patients in Maestro Care system in accordance with physician orders and established policies and procedures
• Serves as expert resource for multiple study teams for participant retention and acts as liaison with other resources at Duke to optimize retention rates and serve our patients.
• Familiar with multiple electronic data capture systems common in clinical trials and clinical documentation including Rave- IMedidata, Citrix, Perceptive Informatics, Redcap, Q" (Coriell Institute), InForm eClinical Systems, Neurobank, Quintiles Infosario, Maestro Care, Perceptive MyTrials, IVRS ClinPhone, Drobox, Forte e-Reg, E-Pro, Bioclinica Smart Upload, TrialMax, IBM System Database, and 4G.

Research program Leader

Neurosurgery Combined Spine Division Research Program Manager:

Responsibilities :

Responsible for development, growth and leadership the Duke Neurosurgery Combined Spine Division's clinical research program under the oversight of the division chief. The program focuses on spinal surgery research, including faculty initiated, foundational, grant, federal and multicenter industry research studies of pediatric and adult scoliosis, spinal cord injury, spinal trauma, and tumors involving the spinal column.

Areas of focus include: Complex Adult Spinal Deformity Surgery, Cervical Deformity, Spinal Cord injury , Intraoperative Monitoring, Robotics, Device studies , American Spine Registry (ASR), Minimally-Invasive Spine Surgery, Lumbar Interbody and Lateral Fusion.

Worked closely with the Division Chief and Business Administrator to determine short- and long-term goals of the program. Determine scope of and changes to research program/portfolio operations; develop, negotiate, and oversee budgets; allocate and forecast resources.

Work closely with the Research Practice Manager, Division Business Administrative Manager, and the Department Chief Administrative Officer to plan, evaluate and implement departmental and division policy related to the CRU and research conduct including resource management and financial strategy to meet the Department, Division and SOM goals.

• Recruit, hire and manage new staff within the Spine research division and work with the Research Practice Manager for training and oversight of departmental CRU staff, including oversight and training of research study team members for the conduct of all research within the Spine Division. Served as a Clinical Research Unit/departmental resource and trainer regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans.
• Oversee implementation of and compliance with the required system for procurement, billing, compliance and proper handling, dispensing and documentation of IP for sponsored protocols, as well as secure storage plans for study documents to protect private health information per IRB, Duke Office of Clinical Research, and School of Medicine policies.
• Oversee maintenance of subject level documentation to include periodic internal audits of study subject and regulatory records. Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings.
• Evaluate processes and employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Determine and implement solutions to recruitment and retention milestones.
• Provide oversight to study team members who conduct and document consent for participants in a variety of studies. Serve as an expert resource with regard to conduct and documentation of consent.
• Serve as expert resource to study teams as they design studies, so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.
• Serve as a resource for development and implementation of Research Data Safety Plans and Conflict of Interest reviews across multiple studies and study teams.
• Prepare and submit CQMP monitoring plans for studies requiring School of Medicine internal monitoring for the division and oversee the study team response to findings including CQMP CAPA plans and map protocol data flow and predict areas of vulnerability through periodic audit reviews. Determine solutions for vulnerabilities for data flow plans for multiple studies.
• Work with faculty investigators to select methods of data capture and discuss advantages and disadvantages of each, recognizing and reporting vulnerabilities related to security of physical and electronic data.
• Serve as a key member of the division’s Spine Protocol Review Committee to conduct thorough feasibility reviews for proposed protocols, including scientific, budget and resource availability for Division approval and determine solutions to identified proposal shortcomings.
• Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.
• Participate in committees, task force, or ad hoc group at the division, unit, department, or institution level including ASR Development Committee, Spine Strategic committees, CRU Leadership Committee, and Spine Protocol Review Committee.
• Use system reports to monitor unit, division, or department compliance with institutional requirement/policies, monitor performance metrics, and assist stakeholders, faculty and CRU team members with understanding these requirements and policies through programmatic presentations (to improve compliance, review metrics, provide updates and review GCP for the purpose of improving study outcomes and achieving the division goals). Ensure that institutional communications are shared with the staff within the research program though weekly team huddles, monthly meetings and quarterly Division faculty meeting presentations.
• Develop study budgets and collaborate with sponsors and financial managers to troubleshoot under budgeted studies, establish financial monitoring systems, and review financial health of individual studies, as well as the Division.
• Oversee study teams’ maintenance of essential documents including Delegation of Authority Logs and training of key personnel on study specific duties.

In addition to managerial responsibilities, this position supported division goals in the role of Clinical Research Nurse Coordinator, providing primary coordination and support of division studies to include:

- Ambulatory Medication Administration

- All aspects of clinical trial coordination and documentation

- Regulatory study start-up, activation, maintenance, and

closeout.

- Feasibility review

- Budget planning

- Resource development

- Preparation, management and participation in study audits

- Patient education of participants in research trials.

- Participant functional testing and administration of patient

reported outcome tools.

- Assist patients with appointments and billing concerns.

- Act as a liaison between participants and their clinical

providers and aid participant access to clinical care.

- Arrange patient transportation and assistance with care

access needs as they arise.

- Participate in community outreach to support the goal of

inclusion and diversity in clinical research

• Coordinate and participate in all aspects of clinical research studies conducted by principal investigator(s) at Duke University Medical Center Movement Disorders Clinic, ALS primary Coordinator .
• Assist in evaluating new protocols for feasibility including assessing subject eligibility requirements and availability as well as feasibility of study team time commitment and assessment of resources including equipment, space, and staff experience. Assist in assessment of budget requirements to conduct the trial
• Collaborate with the Primary Investigator on investigator written protocols and study planning, ensuring the training of study staff in the study protocol and required trainings, including CITI training, creating study visit source documents and study files, coordinate multiple entities involved in the study, contribute to IRB submission documents preparation, assist the site monitor in obtaining essential documents for the startup, initiation and ongoing conduct of the study, actively coordinate and participate in site pre- selection visits, site selection visits, investigator meetings, site initiation visits and ongoing monitor visits
• Maintain communication with the sponsor and Clinical Research Organization monitor to ensure appropriate conduct of the clinical trial including adverse event reporting, investigational drug maintenance and accountability, management of study supplies, subject travel reimbursement, study interim analysis data preparation and study closeout procedures, manage and participate in study audits
• Conduct all aspects of protocol execution including the informed consent process of clinical trial subjects, protection of the subject's rights, observing regulatory requirements, and documentation of the consent process, screening, recruiting and enrolling study subjects following state and federal regulations and ICH and Good Clinical Practice Guidelines, conducting study activities in accordance with the protocol following ICH and GCP practices, collecting complete and accurate study data in accordance with the study protocol and ensuring data entry within required timelines established by the sponsor, address data queries in a timely manner working with the study monitor to ensure accurate and high-quality data, collect study laboratory samples via venipuncture and other collection methods
• Maintain study rater certification for ALS Trials including ALS Functional Rating Scale Administration, Manual Muscle Testing, Hand Held Dynamometry and Pulmonary Function testing and cognitive assessments training.

Clinical duties included:

ALS RN for the Duke ALS clinic :

• Assist with lumbar puncture procedures, skin biopsy procedures and other study procedures requiring a licensed provider
• Staff skills training in venipuncture and ALS patient care.
• Placing intravenous catheters for infusions utilizing best standard of practice procedures to reduce risks, monitor for complications and ensure proper infusion techniques
• Perform pulmonary function testing, progression scales, cognitive testing, manual muscle testing, fine motor testing, suicidality assessment.
• Maintain regular professional activities including attending professional conferences and learning opportunities, MDA and ALSA fundraiser - clinic representative

• Conduct supervisory home visits for clients per the State of NC Guidelines
• Review plan of care with client, family and care staff
• Document plan of care, client concerns, changes in medical history and seek appropriate follow up with primary care or other agency as needed
• Conduct intake assessments for new clients to establish care
• Physical assessment of health status of client upon admission
• Supervisory review of nursing assistants in the home environment (part-time).

• Data extraction and entry into the sponsor EMR.

• Staff nurse in the Post Anesthesia Care Unit and pre-op areas of the Ambulatory Surgical Unit
• Responsibilities are the same as outlined above but include pre-op preparation of patients undergoing outpatient procedures
• Responsibilities include legal identification procedures, obtaining physical history, ensuring all consents are signed and dated per legal requirements, surgical marking of site is completed, pre-medication with sedating substances, assisting anesthesiologists with regional and epidural blocks, and IV and indwelling urinary catheter placements.

• Post-Anesthesia Care Unit, Post-anesthesia recovery of multiple patient populations including assessment, observation and intervention of hemodynamic needs in the post-operative period
• Responsibilities included but are not limited to invasive/non-invasive monitoring, lab draws, lab interpretation and follow up, IV starts / restarts, fluid balance observation, pain management including narcotic, regional and epidural management, critical care management, airway management, patient education, family education/bereavement process assistance, discharge planning, team leader, preceptor, weekend charge nurse responsibilities.

• Staff RN floating to unit where needed including PACU, Orthopedics, Urology, Plastics, ENT, Neurology and General Surgery
• General RN beside nursing duties

• Post-surgical care of general surgery patients.