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United Urology Group is Hiring a Research Coordinator Near Hanover, MD
Job Location
Hanover Office - Hanover, MD
Position Type
Full Time
Education Level
High School
Job Category
Research
Description
Are you interested in making a difference in patient care? Learn about our unique culture of respect, growth, innovation, the best patient care, and how we give back to the community.
At United Urology Group , our employees are at the heart of our mission and have incredible opportunities to impact our patients' lives with their urologic care.
- We foster a culture that thrives on compassion, teamwork, integrity, and diversity, all of which start with our staff!
- We deliver a cohesive approach to urologic care that provides patients access to experienced specialists, a superb team of healthcare professionals, and the most advanced technology for patient treatments and therapies.
- We offer competitive salaries and a great work/life balance: enjoy your weekends!
- UUG offers outstanding benefits, including tuition reimbursement, health, dental, and vision insurance, corporate discounts, and much more!
Position Summary:
The Research Coordinator will screen, enroll, and follow study subjects for Phase I, II, III, and IV clinical trials, ensuring protocol compliance and close monitoring while the subjects are in study.
Primary Duties & Responsibilities:
Conducting Clinical Trials
- Review with the Principal Investigator (PI) the inclusion/exclusion criteria, overall structure, and requirements of each protocol and ensure logistics for site implementation.
- Review the protocol and the informed consent form for accuracy and clarity.
- Develop and implement strategies for subject recruitment and ongoing communications with all physicians, research staff, and office staff.
- Complete new trial feasibilities upon review with potential Investigator and submit to Sponsor/CRO. Complete and submit CDA to Sponsor/CRO in accordance with site Standard Operating Procedures (SOP).
- Schedule site Sponsor visits in accordance with internal SOP.
- Prepare study charts, binders, and supplies for offsite storage in conjunction with the Regulatory Specialist, when applicable.
- Ensure maintenance and calibration of site study required equipment.
- Review the study design and inclusion/exclusion criteria with the PI/SI and, if needed, the Sponsor to ensure understanding.
- Review, verify, and record/collect all relevant documentation in the subject's medical record needed to confirm study eligibility.
- Review the protocol, informed consent form, and follow-up procedures with the potential study subjects.
- Ensure the current approved informed consent is signed before subjects are screened and enrolled.
- Inform and document notification of the subject's Primary Care Physician of trial participation if approved by the subject.
- Perform delegated Protocol specific tasks as assigned by Principal Investigator.
- Ensure that the randomization procedures are followed and documented per protocol guidelines.
- Document protocol exemptions and deviations as appropriate. Ensure duplication of each for filing in the subject source and with the regulatory specialist.
- Ensure all procedures and documentation of subject participation are kept in accordance with FDA regulations, ICH guidance, and internal SOP.
- Schedule subjects for follow-up visits, collect subjects' responses to therapy, and interview subjects for adverse events and changes to concomitant medications. Ensuring that a review of EMR is made during the subject visit for any notable medical/medication changes from the last research visit.
- Review laboratory data and communicate abnormal values to the PI/SI andas needed, primary care provider or specialist if additional medical attention is needed.
- Assess and document subject compliance and accountability with Investigational Product (IP). Document re-education when appropriate.
- Communicate with research staff to ensure timely and accurate study drug distribution when applicable.
- Administer study drug therapy as needed and maintain the study drug dispensing log if a pharmacist is not involved.
- Record all Adverse Events outlined in protocol and review them with the PI/SI.
- Report all Serious Adverse Events to the principal investigator, sponsor, and IRB as outlined in the protocol and site SOP. If need be, contact the subject's primary care physician or specialist.
- Reporting all Deviations/Adverse/SAE within Sponsor/IRB's timeframe and in accordance with site SOP.
- Follow SOPs/GCPs/HIPPA according to the site, sponsor, ICH, and FDA.
- Maintenance of accurate and complete documentation, including but not limited to signed informed consent forms, source documentation, drug dispensing logs, subject logs, and study-related communications.
- Follow up and document outstanding action items on Monitoring reports, ensure PI/SI oversight, and that the site Regulatory Specialist receives reviewed/corrected/signed copy of the report.
- File appropriate regulatory or Sponsor communications with the site Regulatory Specialist.
- Create and maintain Master Subject Log and Visit Log.
Qualifications
Qualifications:
- Minimum High School Diploma or GED required.
- Minimum of two (2) years of clinical research experience.
- Maintained certification of accreditation (CCRC/IATA/CPR/NIH/CITI).
- Must have the ability & willingness to travel to other sites as necessary within a geographic region.
- Exceptional customer service skills.
- Strong attention to detail, a willingness to learn & the ability to stay organized.
- Ability to perform clinical assessments.
- Strong understanding of FDA clinical trial phases I-IV.
- Strong understanding of GCP set forth by the ICH.
- Proficient knowledge of medical terminology.
- Proficient knowledge of Research related Terminology.
- Strong communication skills, both verbal & written.
- Proficient computer software and database skills.
- Comfortable working in a fast-paced environment.
- Very comfortable asking probing questions to patients, if applicable.
- Must demonstrate a caring, compassionate, and patient attitude.
- Maintain HIPAA compliance.
- Multitasking and proactive problem-solving.
- Ability to type a minimum of 40 words per minute.
- Regularly required to sit 4-7 hours/day and stand 1-3 hours/day.
- Intermittently required to stoop, bend, speak, and listen.
- Frequently lift and or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
The successful candidate(s) for any UUG position will be subject to a pre-employment background check.
Job Summary
Full Time
$53k-70k (estimate)
05/05/2024
05/18/2024
unitedurology.com
The following is the career advancement route for Research Coordinator positions, which can be used as a reference in future career path planning. As a Research Coordinator, it can be promoted into senior positions as a Clinical Research Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Research Coordinator. You can explore the career advancement for a Research Coordinator below and select your interested title to get hiring information.
If you are interested in becoming a Research Coordinator, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Research Coordinator for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Research Coordinator job description and responsibilities
Research coordinator administers clinical trials under following good clinical practice guidelines.
03/08/2022: Nashville, TN
These coordinators work at clinical research sites where they will study their subjects to ensure the successful operation of the clinical trial.
02/11/2022: Pittsfield, MA
Research coordinators (CRC) prepare, direct, and coordinate clinical trail projects.
01/20/2022: Lawrence, MA
Research coordinators would also collaborate with other representatives that offer equipment or software for the trial to ensure all requirements are met.
02/20/2022: Rapid City, SD
Research coordinators carefully organize clinical studies to produce the most accurate results possible.
01/05/2022: Montgomery, AL
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Research Coordinator jobs
Learn about current research programs.
03/12/2022: Juneau, AK
Research up-to-date guidelines and regulations.
02/05/2022: Washington, DC
Research Coordinators guide their subjects through every aspect of the trials and distribute questionnaires after the study to help researchers gauge their viability.
01/24/2022: Middlesex, NJ
Familiarity with scientific research standards and practices.
02/14/2022: Miami, FL
Research coordinator also performs various administrative tasks required for whichever study they are currently administrating.
02/18/2022: Lansing, MI
Step 3: View the best colleges and universities for Research Coordinator.
