Clinical Research Associate , Lead, DCRI - Gov't & Networks RO - Military Veterans

at Duke University and Duke University Health System

Durham, North Carolina

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

PositionSummary: 

Manage the development, coordination andimp lementation of clinical operations site management and clinical monitori ngresponsibilities for assigned projects with guidance, including trial- specificprocesses and systems, and daily supervision of the Clinical Ope rations teamresponsible for site management and clinical monitoring in a ccordance withcontractual agreements, department guidelines, SOPs, appli cable international,federal and state regulations, and ICH guidelines.

 

Work Performed:

Provide leadership for the Clinical Operations project team r esponsible for site management working in close collaboration with the project leader and other functional group leaders for execution of all monitoring services according to the project-specific scope of work:

·         Def ine, assign, coordinate, oversee and assess utilization and productivit y of the monitoring team members’ daily in-house activities according t o trial-specific scope of work, budget, and timelines. Coordinate and s upervise site monitoring assignments and activities, including scheduli ng of pre-study, initiation, periodic, and close-out site visits within visit windows and according to contractual.

  • Define, assign, coordinate, oversee and assess utilization and pro ductivity of sub-contractors including independent contract CRAs, vendor or sponsor-provided CRAs, and other contracted services.
  • Provide site management and clinical monitoring expertise, and leadership to assigned team. Provide advice and gu idance to team members for assessment, resolution, and documentati on of site and study issues.
  • Identify resource needs and supervise team members’ work assignments, utilization and pr oductivity.
  • Direct and prioritize team efforts and assess overall team progress against study timelines and metrics. Develop performance standards for project team. Identify and notif y appropriate parties of emerging out of scope activities, project change orders andstudy guidelines. Evaluate impact on resource n eeds, study processes and related documents.
  • Review and approve team deliverables focusing on quality and timel iness of all monitoring activities within the defined scope of wor k.
  • Perform activities of Senior CRA as needed to move project deliverables and timelines forward.

·        

Manage the development and mainte nance ofclinical trials documents, processes, and systems according to t rial-specificscope of work and budget with minimal guidance. Participate in the developmentof the protocol, protocolrevisions and amendments, m onitoring plan, scope ofwork and operations manual with guidance.

  • Coordinate the development, use and maintenance o f study-specific processes, related documents, templates and other s ite management, communication, monitoring and regulatory tools.
  • Define site selection and activation guidelines and related activities with Investigator Relations, the project leader, the principal investigator, and the sponsor. Approve sites in colla boration with the project leader and the sponsor.
  • T rain and supervise the team on trial-specific collection, review and approval of clinical trial documents and associated processes. Prov ide final approval of essential clinical trial documents.
  • Observe for consistency in the conduct of the study and d ata collection according to the protocol and study objectives. Overs ee identification of study and site issues and assist with resolutio n and documentation.
  • Provide management of the deve lopment, implementation and maintenance of the clinical trial manage ment system, related tracking tools and status reports.
  • Apply best practices to site management clinicaltrial s processes.

 

Serve as key site ma nagement trial-team member to internal and external partners and to the project core team (project leader, principal investigator and other fu nctional group key representatives).

  • Collabo rate with internal and external partners to develop trial- specifi c tools and processes, with guidance, for efficient management of tracking site and study status, enrollment, data collection, query resolution, and other trial activities.
  • Prov ide input regarding the development of the CRF (data capture forms ) design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports.   
  • Facilitate communication between designated internal and external contacts (including contract s, clinical supplies,pharmacy, and sponsor) and study sites. Faci litate cross-functional team communication and proactive problem s olving regarding study progress and trial issues with guidance.
  • Consult with Clinical Operations administration in the management of the scope of work, associated budget andtim elines.
  • Review and analyze site payments and associated site status against Clinical Operations budget. Consult with the financial group and contract department to facilitate re solution of study and site financial issues with guidance.
  • Manage production, review and approval of trial-related re ports, including site status reports, site payments, regulatory st atus reports, trip reports, and expense reports for internal and e xternal dissemination. Review reports for identification and resol ution of study and site issues.  Notify appropriate team me mbers of findings and action plan. 
  • < span>Organize, lead, and participate in study teleconferences and meetings with the trial team and other study partners.

 

Collab orate with Clinical Operations administration to identify and oversee t rial-related training and performance concerns of monitoring team membe rs according to their individual needs; maintain awareness of level of performance and training needs; provide ongoing input to Senior Clinica l Trials Lead for development of individual training plan.

  • Coordinate and oversee trial-specific training for C RAs which may include therapeutic in-service, reference materials, investigator meeting, team monitor training, on-site co-monitoring and training visits.
  • Coordinate the coaching and training of CRA team members’. Provide and document regular feedba ck and coaching to individual team members. Maintain documentation , providing specific examples of performance issues.
  • Facilitate participation in on-site co-monitor training vi sits for final sign-off of designated CRAs to perform independent site visits.
  • Recognize accomplishments of ind ividual team members and the team as a whole.
  • Assis t with all aspects of performance management including compiling a nd providing feedback to the Senior Clinical Trial Lead for team m embers’ annual performance evaluations, identifying strengths and areas for improvement using specific examples, and providing input for Individual Development Plans. Assist with development and del ivery of performance reviews and work improvement plans.
  • information exchange

Supervise and manage monitori ng trial-teammembers’ adherence to DCRI and sponsor-specific administrat ive policies withguidance. Encourage team members to attend appropriate training and meetings.

  • Review trial-related exp ense reports, timesheets, and time-off requests for use of appropria te project and activity codes and timely completion in accordance wi th applicable travel guidelines and expense reporting procedures; ap prove and process reports.
  • Oversee training and coaching of new monitoring team members on the use of applicable fi nancial and other organizational forms for trial-specific activities , and the effective use of cost and time-saving strategies. Refer em ployees to Senior Clinical Trials Lead if further training or coachi ng is needed.
  • Attend appropriate clinical team leadership meetings, department meetings and organizational meetings .  Encourage team members to attend appropriate team, d epartment and educational meetings.
  • Assist in the development, implementation and revisionof processes, SOPs and s tandard forms.

 

Support the DCRI’s mission, depar tmentgoals and organizational activities.

  • Overs ee team dynamics to foster professional relationships.
  • Maintain awareness of developments in clinical research regu lations and therapeutic areas by reading related literature, attenda nce at professional meetings and research seminars.
  • Encourage and support cross-functional and therapeuticinformat ion exchange.

 

Actively support the Clinical Operationsfunct ional group and the DCRI.

  • Participate in specia l assignments as requested by project leader.
  • I nterview job candidates and make hire recommendations for clinical m onitoring teams.
  • Complete administrative activi ties accurately and in a timely manner, e.g., time tracking, attenda nce reports, training file.

Encourage team to seek opportunities forpersonal dev elopment.

Recei ve and review audit findings, developaction plan for audit response and provide input for formal audit response withguidance.Perfor m other related duties incidental to the workdescribed herein.

Preferred Education/Training: 

Bachelor ’s degree in clinical, health or life science

Preferred Education: Registered Nurse, Nurse Practitioner, Physician’s Assistant, Pharmacist

  

Preferred Experience: 

4-5y ears related clinical research experience including 3 years directly related CRA exper ience or clinical trial management experience

 

Knowledge, Skills and Abilities: 

·     Strong technical spelling and grammarskills, includin g reviewing and proof reading of business documents andcommunications

·     Ability to write, speak, and presentstrategies clearly and concisely in a variety of communication settings andstyles

·     Strong interpersonal skills, ability toestab lish and promote positive business relationships, customer serviceorient ed

·     Abili ty to collaborate with team membersto achieve trial-specific goals withi n specified timelines

·     Ability to collaborate with internal andexternal partners to achieve departmental and organizational goals

·     Ability to lead others and fost erteamwork; ability to manage, motivate and lead teams

·     Proficient computer skill s including MSOffice, Word, Excel and PowerPoint; able to learn and use computer applications

·     Ability to train and coach site managementand clinical mon itoring team members

·     Ability to direct and manage competingindividual and team a ctivities to meet trial objectives, timelines and budget

·     Ability to use critical thinking skills toeffectively solve problems and use conceptual thinkin g to anticipate impact ofdecisions

·     Strong knowledge of medical terminology

·     Understanding of scientific application toclinical trials research

·     Technical knowledge and sk ills for monitoringprocedures and practices

·     Knowledge of clinical research trial operations

·     Strong knowledge of FDA regulations, ICHguidelines, and Good Clinical Practices and their application to clinicaltrials

·     Understanding of departmental SOPs andsystems

·     Ability to travel 25%, some forconsecutive nights

 

 

Minimum Qualifications

 

 

Education

Work requires graduation from an accredited degree program providing

1. Completion of an allied health degree (e.g., Respiratory Therapy, clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus four years of healthcare experience; or one of the following equivalents: Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of six years healthcare experience; or

2.Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or

3. Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research; or

4. Completion of a bachelor's degree plus a minimum of five years closely related research experience.

 

**State of North Carolina license may be required.**

 

Experience

None required beyond that described above OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

 

Duke is an Affirmative Action/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, sexual orientation, or veteran 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 essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

 

Durham, North Carolina

As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.

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