Job Description

Department: MED-Physical Med & Rehab Salary/Grade: RES/ Target hiring range for this position will be between $75,000-$100,000 per year. Offered salary will be determined by the applicant’s education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Seniority Level Entry level Employment Type Part‑time Job Function Research, Analyst, and Information Technology Industries Higher Education Job Summary 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. Specific Responsibilities Become familiar with all protocols conducted at the center. Participate in the initiation of study start‑up activities. Contribute to the implementation of protocols and monitor study activities at all stages. Evaluate volunteer subjects for potential study qualification in accordance with inclusion/exclusion criteria provided by study sponsor. Assist in patient recruitment as well as acting as a resource for the marketing personnel and referring physicians. For qualified participants, initiate medical and social histories, physical exam, and physiological measures as indicated in protocol. Record this data in detail. Schedule study visits as required by protocols. Ensure appropriate laboratory, x‑ray and other diagnostic examinations are scheduled and completed per study protocol. Oversee any outside services as required. Conduct all necessary laboratory and imaging tests. Perform complete medical histories and physical examinations for qualified participants with emphasis on patient’s presenting complaints and findings pertinent to the study. Discriminate between normal and abnormal findings on history and physical in order to establish a differential diagnosis. Provide clinical support for divisional research activities within scope of license. Review medical, laboratory, and other diagnosis data on study patients. Recognize conditions beyond the scope of the Nurse Practitioner/Physician Assistant and confer with principal investigator. Make principal investigator aware of any significant abnormalities. Notify and follow up with patients as appropriate. Assist coordinators in assessment of adverse events. Ensure that serious adverse events are reported to the principal investigator and sponsor in a timely manner. Follow up with patients or patient family members in accordance with procedures. Knowledge of community resources needed for patients. Assist with collection of data requested by protocol. Ensure accuracy of data obtained. Collate and enter data into patient charts, sponsor case report forms, and/or remote data entry equipment in a timely and precise manner. Ensure that all study drug received in unit is accurately documented and sorted in locked location. Ensure that study drug is maintained in appropriate temperature controlled environment. Verify that all study drugs are correctly labeled and packaged. Ensure that appropriate study drug is dispensed to patient along with detailed instructions on use. Maintain accurate documentation of each of these along with return study drug. When studies require other supplies and/or equipment, ensure their availability and ensure proper orientation has occurred prior to use. Ensure patient compliance with study drug and study visits. Document all efforts made to retrieve study medication. Notify sponsor of any deviations from protocol. Whenever possible, obtain permission prior to deviation. Schedule routine study reviews with sponsor monitors or appointed sponsor representative. Arrange access to all subject records for the indicated time period of review. Allow time to respond to monitor questions and to make corrections to case report forms. Promptly respond to sponsor queries. Prepare for and complete close out procedures for terminated studies. Ensure 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. Work with other research coordinators and research assistants to provide back‑up, replacement during absences, and follow‑up as needed. Provide health practices information and education to study patients regarding medications, disease, diet, exercise, and any special procedures. Assist patients by providing appropriate referrals to physicians, clinics, or agencies. Provide on‑call services for study patients during evening and weekend on rotation basis with other coordinators/nurse practitioners/physician assistants. Perform diagnostic procedures as required by study protocol. Assist in training of center personnel, especially in the clinical assessment skills including blood draw and performing ECGs. Ensure gowns, gloves, goggles, masks and other personal protective equipment are used properly by all staff. Participate 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. Performs other duties as assigned. Minimum Qualifications 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. Minimum Competencies Excellent clinical assessment 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 other health‑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. Preferred Qualifications Previous research experience and 3+ years clinical experience as a Nurse Practitioner/Physician Assistant. Graduate of an accredited master’s program for Nurse Practitioner or Physician Assistant. Benefits At Northwestern, we are proud to provide meaningful, competitive, high‑quality health care plans, retirement benefits, tuition discounts and more! Visit us at to learn more. Work‑Life And Wellness 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 to learn more. Professional Growth & Development 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 to learn more. Equal Opportunity Employer Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern’s non‑discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process. #J-18808-Ljbffr Northwestern University

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