Job Listing: Research Study Nurse

Aerotek is Seeking a Clinical Research Study Nurse in Frederick, MD with the following responsibilities!

The Clinical Research Study Nurse’s duties and responsibilities include advising the Program staff in the execution of clinical protocols, monitoring clinical studies for compliance with the FDA regulations, and assisting reports and regulatory files submissions.

The principal objective for this candidate is to assist the principal investigator for clinical protocols and acquire study data for regulatory purposes. The employee will perform duties and responsibilities independently based on broad guidelines and objectives provided by the supervisor and own initiative. Specific requirements are:

NURSING CARE:

- Work involves planning, organizing and executing clinical protocols for investigational new vaccines and licensed vaccines.
- Ability to participate in the development and revision of clinical protocols.
- Ability to provide direct nursing services (care) using the nursing process in support of research protocols.
- Ability to provide nursing services in the treatment of occupational illness and/or accidents associated with work, which may involve exposure to highly infectious, contagious or toxic substances.
- Provide direct patient care daily, using the nursing process in support of research protocols.
- Serve as staff nurse in the Clinic providing direct technical guidance to paraprofessional nursing staff members.
- Ensure appropriate and accurate documentation of patient care in the medical record and in designated case report forms and specific computer programs.
- Advise, perform, and instruct staff, research participants and/or others about protocol-specific procedures and treatments, equipment, policies, adverse medication reactions, and follow-up instructions appropriate to the research study.
- Perform and/or assist in participants’ briefings and screenings, to include obtaining of informed consent.
- Regularly updates research investigators of relevant issues, concerns, and progress of study.
- Provide summary report of all study activities to the Principle Investigator (PI) and Chief.
- Assist research investigators in collecting study data and statistics.
- Assist PI in submitting final and annual report for the study.

ADMINISTRATIVE:
- Assist in developing protocol-specific recruitment strategies, to include briefing slides, flyers, advertisements and phone script.
- Interact with extramural sites for scheduling, consenting, and follow-up
- Write and review Standard Operating Procedures (SOP) and Study Specific Procedures (SSP) and guidelines.
- Ensure that studies are implemented in full compliance with Good Clinical Practices (GCP) and Department of the Army (DA) regulations, guidelines, and practices.

QUALITY CONTROL:
- Quality Control (QC) of tracking and filing of all protocol laboratory test results and samples.
- QC the preparation of study charts, case report forms, labels and laboratory and other test results.
- QC of test article (vaccine) accountability.
- QC of regulatory study file to include filing of necessary documents per protocol SOP, Food and Drug Administration (FDA) and DA requirements.

MEET EITHER OF THESE EDUCATION/EXPERIENCE LEVELS:

1. Associate of Arts degree in nursing program at an accredited college OR certified completion from an accredited Licensed Practical Nurse (LPN) school of nursing plus Certified Clinical Research Coordinator/Associate (CCRC) certification within six (6) months of selection into this position. Candidate must have a minimum of three years of recent experience in the medical research setting.
2. Bachelor of Science in Nursing degree from an accredited college

- Must hold a license as a licensed practical nurse or registered nurse in the State of Maryland
- Must be GCP (Good Clinical Practice) trained or be willing to attend GCP training
- Must possess computer skills in the following computer software programs: Microsoft Office/Word and be willing to learn Excel.
- Collaborating with developing of the Clinical Data Management System (CDMS)
- Must have current BLS certification
- Must complete DoD HIPAA training
- Must comply with proper handling of classified information

Required Skills for Research Study Nurse Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.