RESEARCH PROGRAM LEADER - PEDIATRICS
RESEARCH PROGRAM LEADER - PEDIATRICS
The Program Leader position will work closely with Drs. Lang and Sleasman on designated projects inthe Pediatric Asthma, Allergy/Immunology and Airways Research Program. This position will call upon significant past experience in clinical trials to develop, coordinate and implement research and administrative strategies essential to the successful management of clinical trials conducted by Drs. Lang and Sleasman. The PL will require someone with leadership skills, a positive attitude and enjoys working on teams. He/she will require professionalism, excellent organization and communication skills, maturity and interest in mentoring. This position will perform a variety of duties involved in the organization, documentation and compilation of clinical research data;function in a preceptor capacity for research coordinators, research assistants, and designated staff, and serve as a primary operations support to Drs. Lang and Sleasman. Drs. Lang and Sleasman will ensure that there is a reasonable workload and the position is equipped for success.
Tasks will vary somewhat depending on active project and may be called upon to do one or more of the following:The PL will help with hiring, management and performance reviews ofstudy staff. Assist inmonitoring project budgets; regulatory responsibilities for designated active projects (assist withwritten and verbal communications with IRB, FDA, Sponsor, DataMonitoring Committees, etc);compliance with staff training requirements; input into study recruitment strategies, research program marketing strategies; and auditing charts to ensure adherence to GCP in order to develop a productive and safe research program. Recommend guidelines and refinement of guidelines in the collection of clinical data and administration of clinical trials; assist in the determination of guidelines for new protocols. Assist the principal investigators and other team members in the development of plans, time lines,and processes for clinical research studies; coordinate the ongoing analysis and modification of protocols; recommend amendments to study protocols as appropriate.Confer with coordinators,physicians and other research staff to explain protocol and to elicitcompliance with regulations;assure adherence to FDA and protocol guidelines; identify potentialproblems and/or inconsistencies and take action as appropriate.Coordinateand lead the work ofthejunior research staff (CRC, assistants, Fellows, others) and provide feedback to staff's supervisor on a routine basis; conduct functional research team meetings as needed.
In conjunction with Drs. Lang and Sleasman, participate in initial contacts with outside vendors and internal functional groups for potential projects including early trial budget negotiations and contract development. Perform other related duties incidental to the work described herein.
Regulatory/Administrative (examples):Oversee projects with Drs. Lang and Sleasman to ensure research program projects are conducted in compliance with protocol guidelines, regulatory agencies and institutional boards.
Run weekly lab or project meetings (report on progress of activeprojects)o At first this may include just 2-3 people but is planned to grow to include multiple coordinators,fellows and junior faculty.
Training requirements (CITI, etc.) for all key personnel and staff on active projects
Assist in writing yearly reports to IRB (and other reporting as needed
Assist CRCs with reporting of SAEs as needed to IRB. Assist in writing yearly reports to FDA for all required projects
Discuss Performance management for staff
Assist with training research staff on regulatory/administrativeduties as needed
Assist with regulatory aspects of stored clinical research samples inDr. Sleasman's and Lang's lab
Assist with the development of Case Reportand Consent forms
Proof-read/editdrafts of CRF,protocols, MOPs and consent forms. Assist in the preparation of amendments to protocols and/or modifications to study design as appropriate.
Collaborate on the preparation of manuscripts for publication through proof-reading,literature research and targeted writing. Learn and grow; new ideas are welcome
Financial: Assist in the review of budgets with budget team and with JL and JWS.
Assist with long-term planning of program
Assist in creating new budgets
Data Science: Identify operational problems with data collection and entry
Assist with data audits
Monitor interactions and ensure adherence with Investigational Drug Services procedures
Interact with REDCap team and trouble shoot problems with timely data entry.
Learn and help facilitate Duke electronic health records Data Queries(Deduce
Research coordination: Direct hands-on research coordination will be limited. As a PL,familiarity with certain research procedures will be important to develop. These may include pulmonaryfunction testing, sample processing and sample storage. Oversee proper storage of research equipment and binders.
Recommend changes to PIs as needed to improve safety, quality and efficiency.Provide support to CRCs with study procedures as needed (rare). Assist in training new personnel as directed/approved by Drs. Lang and Sleasman.
Assist PIs in overseeing recruitment progress and reaching recruitment goals.
Reviews test results (especially abnormal or critical values) and bring to the attentionof Drs.Lang or Sleasman, or other investigators as appropriate.
1280 RESEARCH PROGRAM LEADER
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, 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 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.
1.Completion of a bachelor's degree plus a minimum of four years ofresearch experience2.Completion of a master's degree plus a minimum of two years ofresearch 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.