Clinical Research Associate

Northwestern University • Chicago, IL

68d • $75,000 - $100,000

About The Position

The Clinical Research Associate is responsible for coordinating clinical research-related activities as well as providing clinical research support to the research group. The PA/NP manages activities associated with highly complex clinical research studies including investigator-initiated trials single and multi-center trials and industry-initiated trials. Responsibilities include: performing patients assessments, conducting patient visits, collecting and documenting clinical research data, attending clinical trial conferences and meetings, acting as a liaison between patients and physicians, and acting as a resource to research study patients, physicians, and other/clinical personnel. This individual is the primary contact for all participants and coordinators to access at any time of day. This individual uses advanced communication skills to problem solve complex situations. This individual will provide clinical support and clinical research activities to the PI. This individual acts as a sub investigator on all clinical trials at any given time. The hours for this job are flexible and can be either part-time or full-time.

Requirements

• Graduate of an accredited Nurse Practitioner or Physician Assistant program; current Illinois licensure.
• Must complete NU's IRB CITI training before interacting with any participants and must re-certify every 3 years.
• Excellent clinical assessments skills
• Detail-oriented and highly organized.
• Ability to understand technical research protocols.
• Excellent problem solving skills.
• Able to make decisions independently and yet must be team oriented.
• Must possess ability to articulate and clearly communicate study information to patients, and otherhealth care professionals.
• Excellent written and oral communication skills.
• Professional demeanor with ability to interact with pharmaceutical/sponsor representatives,regulatory agents, medical center administration, medical staff, peers, and patients.

Nice To Haves

• Previous research experience and 3+ years clinical experience as a Nurse Practitioner/PhysicianAssistant.
• Graduate of an accredited master's program for Nurse Practitioner or Physician Assistant.

Responsibilities

• Become familiar with all protocols conducted at the center. Participates in the initiation of study start-up activities. Contributes to the implementation of protocols and monitors study activities at all stages.
• Evaluates volunteer subjects for potential study qualification in accordance with inclusion/exclusion criteria provided by study sponsor. Assists in patient recruitment as well as acting as a resource for the marketing personnel and referring physicians.
• For qualified participants, initiates medical and social histories, physical exam, and physiological measures as indicated in protocol. Records this data in detail. Schedules study visits as required by protocols.
• Ensures appropriate laboratory, x-ray and other diagnostic examinations are scheduled and completed per study protocol. Oversees any outside services as required. Conducts all necessary laboratory and imagining tests.
• Performs complete medical histories and physical examinations for qualified participants with emphasis on patient's presenting complaints and findings pertinent to the study. Discriminates between normal and abnormal findings onhistory and physical in order to establish a differential diagnosis. Provides clinical support for divisional research activities within scope of license.
• Review medical, laboratory, and other diagnosis data on study patients. Recognizes conditions beyond the scope of the Nurse Practitioner/Physician Assistant and confers with principal investigator. Makes principal investigator aware of any significant abnormalities. Notifies and follows up with patients as appropriate.
• Assists coordinators in assessment of adverse events. Ensures that serious adverse events are reported to the principal investigator and sponsor in a timely manner. Follows up with patients or patient family members in accordance with procedures. Knowledge of community resources needed for patients.
• Assists with collection of data requested by protocol. Ensures accuracy of data obtained. Collates and enters data into patient charts, sponsor case report forms, and/or remote data entry equipment in a timely and precise manner.
• Ensures that all study drug received in unit is accurately documented and sorted in locked location. Ensures that study drug is maintained in appropriate temperature controlled environment. Verifies that all study drugs is correctly labeled, and packaged. Ensures that appropriate study drug is dispensed to patient along with detailed instructions on use. Maintains accurate documentation of each of these along with return study drug.
• When studies require other supplies and/or equipment, will ensure their availability and ensure proper orientation has occurred prior to use.
• Ensures patient compliance with study drug and study visits. Documents all efforts made to retrieve study medication. Notifies sponsor of any deviations from protocol. Whenever possible, obtains permission prior to deviation.
• Schedules routine study reviews with sponsor monitors or appointed sponsor representative. Arranges access to all subject records for the indicated time period of review. Allows time to respond to monitor questions and to make corrections to case report forms. Promptly respond to sponsor queries.
• Prepares for and completes close out procedures for terminated studies. Ensures all FDA, sponsor, and center regulations have been followed.
• Assist with training of other center personnel who will be directly involved with the assigned study.
• Works with other research coordinators and research assistants to provide back-up, replacement during absences, and follow-up as needed.
• Provides health practices information and education to study patients regarding medications, disease, diet, exercise, and any special procedures. Assists patients by providing appropriate referrals to physicians, clinics, or agencies.
• Provides on-call services for study patients during evening and weekend on rotation basis with other coordinators/nurse practitioners/physician assistants.
• Performs diagnostic procedures as required by study protocol.
• Assists in training of center personnel, especially in the clinical assessment skills including blood draw and performing ECGs . Ensures gowns, gloves, goggles, masks and other personal protective equipment are used properly by all staff.
• Participates in other division activity such as special projects, in-service, training, and any other duties assigned by supervisor
• Must take the certification exam within 2 years, or with 1 year if has 1 year previous experience as a research coordinator.

Benefits

• At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.
• Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles.
• We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.
• Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Educational Services
• Number of Employees: 5,001-10,000 employees