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Aerotek Clinical Research Nurse in Indianapolis, Indiana

Description:

Job Functions:

The Clinical Research Nurse will initiate, conduct, complete, and report clinical studies/trials. Manage patient interactions and follow-up including recruitment, consent, and study visits. Assign and coordinate activities of study sites to ensure protocol, regulatory and standard operating procedures (SOP) and Good Clinical Practice (GCP) compliance. Schedule, prepare for and participate in monitor visits. Prepare and respond to Sponsor or FDA audits. Develop solutions to complex problems that impact the timely and accurate conduct of clinical research.

Other duties and responsibilities:

  • Coordinate and administer new clinical research study activities and those studies from nursing staff.

  • Actively recruit research participants to reach accrual goals.

  • Complete local and Central IRB trial submissions for new studies.

  • Complete Regulatory aspects of study start-up for new and ongoing studies.

  • Data Entry of study data from ongoing and new studies (SHORE, as massive amounts of data are collected for each participant).

  • Collect and report study data from ongoing and new Research participants including AE and SAE data as applicable.

  • Provide guidance and support to junior level peers.

  • Extract data from source documents and completed CRFs. Work with PIs to determine SAEs and AEs.

  • Maintain Current knowledge of regulatory affairs and/or Issues. Maintain a high level of expertise through familiarity of clinical literature and/or attending continuing educational classes.

Skills:

Clinical research, Clinical trial, Gcp, Ekg, Crf, Crc, Patient recruitment, Epic, Clinical study, gastro, gastroenterology, Hepatology

Top Skills Details:

Initiate, conduct, complete, and report clinical studies/trials in Gastroenterology. Assign and coordinate activities of study sites to ensure protocol, regulatory and standard operating procedures (SOP) and Good Clinical Practice (GCP) compliance. Develop solutions to complex problems that impact the timely and accurate conduct of clinical research.

Must haves:

  • BSN

  • Research EXP and Home health or management

  • They need the person to be able to have functional management exp

Preferred:

  • Exp in liver trials

  • Clinical Research experience - CRC that is a nurse

Additional Skills & Qualifications:

Position with be on Dr. Ormans team - he currently has a trial that is going to be issued a large sum of money in grant funding. The protocol originally had the nurse going into the homes of the subjects, but due to covid that has been changed. Looking for someone with experience in research w/a BSN and has home health experience

Experience Level:

Intermediate Level

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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