CLINICAL RESEARCH ASSOCIATE, LEAD
CLINICAL RESEARCH ASSOCIATE, LEAD
DCRI - Site Support & Management
Occupational SummaryPosition Summary:
Manage the development, coordination and implementation of clinical operations site management and clinical monitoring responsibilities for assigned projects with guidance, including trial-specific processes and systems, and daily supervision of the Clinical Operationsteam responsible for sitemanagement and clinical monitoring in accordance with contractual agreements, department guidelines, SOPs, applicable international, federal and state regulations, and ICH guidelines.
Primary Responsibilities and Tasks:Provide leadership for the Clinical Operations project team responsible 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.
Manage the development and maintenance of clinical trials documents,processes, and systemsaccording to trial-specific scope of work and budget with minimalguidance.
Participate in thedevelopment of the protocol, protocol revisions and amendments,monitoring plan, scope of workand operations manual with guidance.
Serve as key site management trial-team member to internal and externalpartners and to theproject core team (project leader, principal investigator and otherfunctional group keyrepresentatives).
Collaborate with Clinical Operations administration to identify andoversee trial-related training andperformance concerns of monitoring team members according to theirindividual needs; maintainawareness of level of performance and training needs; provide ongoinginput to Senior ClinicalTrials Lead for development of individual training plan.
Supervise and manage monitoring trial-team members' adherence to DCRIand sponsor-specificadministrative policies with guidance.
Encourage team members to attendappropriate training andmeetings.
Support the DCRI's mission, department goals and organizationalactivities.
Required Education and Experience Bachelors degree in clinical, health or life science, with preferred training as Registered Nurse,Nurse Practitioner, Physician's Assistant, Pharmacist.
4-5 years related clinical research experience including 3 years directly related CRA experience or clinical trial management experience.
Knowledge, Skills and Abilities• Strong technical spelling and grammar skills, including reviewing and proof reading of business documents and communications• Ability to write, speak, and present strategies clearly and conciselyin a variety ofcommunication settings and styles• Strong interpersonal skills, ability to establish and promotepositive business relationships, customer service oriented• Ability to collaborate with team members to achieve trial-specific goals within specified timelines• Ability to collaborate with internal and external partners to achievedepartmental andorganizational goals• Ability to lead others and foster teamwork; ability to manage,motivate and lead teams• Proficient computer skills including MS Office, Word, Excel and PowerPoint; able tolearn and use computer applications• Ability to train and coach site management and clinical monitoringteam members• Ability to direct and manage competing individual and team activitiesto meet trialobjectives, timelines and budget• Ability to use critical thinking skills to effectively solve problems and use conceptual thinking to anticipate impact of decisions• Strong knowledge of medical terminology• Understanding of scientific application to clinical trials research•
Technicalknowledge and skills for monitoring procedures andpractices• Knowledge of clinical research trial operations• Strong knowledge of FDA regulations, ICH guidelines, and GoodClinical Practicesand their application to clinical trials• Understanding of departmental SOPs and systems• Ability to travel 25%, some for consecutive nights
2985 CLINICAL RESEARCH ASSOCIATE, LEAD
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, gender, gender expression, genderidentity, 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 robustexchange of ideas—an exchange that is best when the rich diversity ofour perspectives, backgrounds, and experiences flourishes. To achievethis exchange, it is essential that all members of the community feelsecure and welcome, that the contributions of all individuals arerespected, and that all voices are heard. All members of our communityhave a responsibility to uphold these values.
Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
Work requires graduation from an accredited degree program providingclinical training as a Registered Nurse (RN), Physician's Assistant (PA)or Pharmacist plus four years of healthcare experience; or one of thefollowing equivalents:1. Completion of an allied health degree (e.g., Respiratory Therapy,Radiologic Technology, Licensed Practical Nurse) or Associates degree inClinical Trials Research related curriculum plus a minimum of six yearshealthcare experience; or2.Completion of a master's degree in Public Health, HealthAdministration or a related area with three years directly relatedclinical trials research experience; or3. Completion of a bachelor's degree plus a minimum of four yearsdirectly related experience in clinical trials research;or 4. Completion of a bachelor's degree plus a minimum of five yearsclosely related research experience.**State of North Carolina license may be required.**
None required beyond that described aboveOR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
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 provision for requests for reasonable accommodation will be provided by each hiring department.