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Position Summary: The clinical trial research assistant/data manager in the Department of Internal Medicine will be an integral member of the research team with a primary focus on studies in the Division of Pulmonology. This position will provide support for research in pulmonology by co n d u c ting multiple clin i c al tria l s with respo n sibiliti e s inc l udi n g r e cruit m ent of res e arch participants, a d minis t ering r e se a rch prot o c o l s, and col l ecti o n and analys i s of d a ta.
Protocol Development/Management and Study Responsibilities
Assist in the preparation of IRB forms and annual reviews for clinical trials and PI-initiated studies
Provide IRB support and instruction to pulmonary Principle Investigators.
R e se a rch a n d evaluate c u rr e nt literature on metho d s and tren d s p ertaini n g to appropriate topics; evaluate the methods and trends.
Serve as a m emb e r of the interd i sc i plin a ry clinical r e search team to plan, deliver and eval u ate the health care provid e d to rese a rch pro t ocol p artic i p a nts.
Ass i st with prepar i ng a n d writing r e se a rch pro g r e ss repor t s and s u mmary data f or i n c l us i on in rep o rts, presentatio n s , a n d jour n als.
Research/Clinical Activities; Subject Recruitment and Enrollment
Prep a re a n d pr e s ent e d ucational mat e r i als for p a rtic i pants and ot h er staff to carry out prot o c o l therapy as n eed e d.
Serve as a liaison to pulmonary and adjunct department physicians in facilitating protocol procedures and relating patient care information.
Attend research meeti n gs as r e qu i red. Org a nize study pr o c e d ur e s a n d follow study p arti c i p ants an d maintain r e cords of the i r visits and int e rviews.
Com m un i ca t e with study spo n sors a n d/or c o ntr a ct r e se a rch organ i zatio n s a b out the status of the rese a rch proj e c t.
Maintain skil l s and com p etenc i es relat e d to pulmonary patient assessment, sp e c ial e quipm e n t, medicati o ns a nd proced u r e s.
Recruit, screen and enroll participants, ensuring all the prerequisites are complete and conform to required parameters and consent is obtained according to standards
Assist with and collect data on pulmonary assessments according to international standards as part of study data collection.
Assist with the dispensing of study-related medications per protocol with explanation of potential side effects and instructions on how to take the medications.
Responsible for collecting, assembling and mailing charts, bills, specimens, X-rays and slides.
Obtain a n d proc es s hum a n blood a n d tissue samp l es for use.
Data Collection and Monitoring
Use Epic to search for and extract patient data
Use various database programs to input data collected as part of multi-site collaborative studies.
Upload lung MRI, CT and X-ray images to database programs.
Regulatory Guidelines and Documents
Follow Federal Regulations related to human subjects research and assist pulmonary department physicians in maintaining regulatory documents.
Follow u niversal precauti o ns a n d ge n eral p o lic i es a n d pr o c e d ures in accorda n ce w i th university, collegiate, hospital a nd federal g uide l ines.
Attend IRB trainings and stay up to date on all policies and procedures and provide instruction to research team members.
Administ e r assig n ed a s p e cts of the vari o us st u dy co m pon e nts, inc l uding enrolling, sche du ling visits in the clinical research clinic, org a niz a tion of multiple teams involved in c a re of the participants, coll e cti n g and a n alyz i ng data.
Coordinate enrollment for pulmonary studies with ED intern enrollment team
Maintain effective working relationsh i ps with faculty, staff, students and the publ i c .
Seek o p p o rt u nities to en ha nce o ne ' s own prof e ss i on a l kn o w le d ge a nd abiliti e s.
Provide assistance with pulmonary procedure financial loss analysis
A Bachelor's degree in a Health Science field or an equivalent combination of education and experience is required.
Ability to work some weekends, evenings, and nights per study protocol as required.
Experience working in a clinical research related position.
Demonstrated excellent written and ver ba l comm u nication skills with patients/families, and interdisciplinary team members as demonstrated through written and verbal interactions are required.
Working knowledge of Good Clinical Practice (GCP) is the ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects is required.
Excellent time management skills and the ability to perform detail oriented work is required.
Working proficiency in computer software applications (MS Word, Excel, Outlook and PowerPoint) is required.
Previo u s basic ex p erie n ce a nd p artici p ation w i th clinical tria l s is highly desirable.
Experience working in a laboratory processing and shipping research samples.
Working experience in processing research regulatory documents and study budget preparation is desirable.
Phlebotomy skills experience is desirable.
Experience with REDCap and I-Cart Applications is desirable.
Basic experience with preparation of IRB submissions is desirable.
Licensed RN, MA, or Respiratory Therapist is desirable
Basic experience (6 months) caring for pulmonary patients is desirable.