How to Be Orthopedic Clinical Research Coordinator - Job Description, Skills, and Interview Questions

Jul 18, 2023 / 5 Minutes Read / By Albert

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The role of an Orthopedic Clinical Research Coordinator is critical to the successful outcomes of research studies in the orthopedic field. These coordinators are responsible for ensuring the accuracy and integrity of the data collected during the research study, as well as managing all administrative aspects of the research project. By carefully monitoring the research process and providing clear project management, an Orthopedic Clinical Research Coordinator can ensure that the research data is valid and reliable, and that the results are useful for informing medical decisions.

they are responsible for recruiting and enrolling participants, collecting and analyzing data, and maintaining all records associated with the research study. As a result, Orthopedic Clinical Research Coordinators play an important role in advancing medical knowledge and improving patient care in the field of orthopedics.

Steps How to Become

Obtain a Bachelor's Degree. The first step to becoming an orthopedic clinical research coordinator is to obtain a bachelor's degree in a health-related field, such as biology, health science, or public health.
Gain Experience. Working as a medical assistant or research assistant in an orthopedic clinic or research lab can provide valuable experience that may help you land a job as an orthopedic clinical research coordinator.
Earn Certification. The Association of Clinical Research Professionals (ACRP) offers the Certified Clinical Research Coordinator (CCRC) credential for individuals who have experience in clinical research and pass the certification exam.
Pursue Advanced Degrees. A master's degree in clinical research or a related field may be beneficial for individuals who want to become an orthopedic clinical research coordinator.
Obtain Licensure. Depending on the state, individuals may need to obtain licensure as a clinical research coordinator in order to practice in the field.
Maintain Professional Membership. Joining organizations such as the ACRP may be beneficial for individuals who want to stay informed about new developments in the field and network with other professionals.

The Orthopedic Clinical Research Coordinator must stay ahead and capable in the field in order to ensure the accuracy and success of their research projects. Staying informed of the latest research, advances in technology, and best practices in the field is essential for staying ahead and capable. honing communication, organizational, and problem-solving skills can help the Coordinator be well-prepared for any challenges that may arise.

Furthermore, cultivating a network of professionals in the field can provide insight, resources, and support that can be invaluable when confronting difficult tasks. In order to remain competitive and knowledgeable, the Orthopedic Clinical Research Coordinator must stay informed, hone their skillset, and build relationships with other professionals in the field.

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Job Description

Design and monitor clinical trials according to regulatory requirements, Good Clinical Practice (GCP), and Standard Operating Procedures (SOPs).
Manage data collection, entry and analysis of study results.
Prepare and submit documents for regulatory approval, such as IRB applications, study protocols, and participant consent forms.
Recruit, screen and enroll study participants.
Monitor patient progress throughout the study period.
Collect and maintain data from patient charts, questionnaires, lab results, and other sources.
Train and educate research staff on protocol requirements and standard operating procedures.
Lead trial-related meetings with the research team.
Develop study materials, such as patient education brochures and training manuals.
Develop trial-related databases and data entry systems.
Track and monitor budget expenditures throughout the study period.
Complete study close-out procedures and final reporting requirements.

Skills and Competencies to Have

Clinical research experience in the orthopedic field
Knowledge of federal regulations related to clinical research
Ability to analyze and interpret clinical data
Proficiency in relevant computer software, such as Microsoft Office, statistical software and electronic medical record systems
Excellent organizational and communication skills
Ability to work independently and collaboratively with a multidisciplinary research team
Ability to prioritize tasks and meet deadlines
Knowledge of Good Clinical Practice (GCP) guidelines
Familiarity with clinical trial protocols and procedures
Detail-oriented approach to data collection and management

The ability to conduct and coordinate clinical research is essential for any Orthopedic Clinical Research Coordinator. Successful research coordinators must have strong organizational and communication skills, be able to manage multiple tasks and deadlines, have knowledge of research methodology and data management, and be proficient in using computers and technology to analyze data. they must have the ability to think critically, analyze data, and be adept at problem solving.

In addition to these skills, research coordinators must also possess the ability to share information with other research professionals in a clear and concise manner, as well as the ability to collaborate with team members to ensure that all research objectives are met. All of these skills are necessary for successful clinical research coordination, as they help ensure that each research project is conducted properly, efficiently, and effectively.

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Frequent Interview Questions

What experience do you have in research and clinical studies?
What is your experience with regulatory compliance and databases like REDCap?
How familiar are you with relevant data collection methods and analysis techniques?
How do you ensure the accuracy of data collected?
What challenges have you faced when coordinating clinical trials?
Describe a situation in which you had to juggle multiple tasks simultaneously.
How do you stay organized and up-to-date on project progress?
How do you handle difficult conversations with patients or sponsors?
What strategies do you use to maintain consistency in data collection across multiple sites?
How do you ensure patient safety protocols are followed during a study?

Common Tools in Industry

Electronic Medical Record (EMR) System. A digital database of patient information used to track and store medical records (eg: Epic, AllScripts).
Clinical Data Management System (CDMS). Software used to enter, manage, and report on clinical trial data (eg: Oracle Clinical).
Clinical Trial Management System (CTMS). Software to manage the administrative, financial and operational aspects of clinical trials (eg: CTMS by Medidata Solutions).
Statistical Analysis Software (SAS). Software used to analyze and interpret data from clinical trials (eg: SAS 9. 4).
Electronic Data Capture System (EDC). Software used to collect and store data from clinical trials (eg: InForm by Oracle).
Clinical Outcome Assessments (COA). Software to measure patient-reported outcomes for clinical trials (eg: PRO-CTCAE by Merck).
Regulatory Document Management System (RDMS). Software for organizing and managing documents required for clinical trials (eg: Veeva Vault).

Professional Organizations to Know

American Orthopaedic Society for Sports Medicine
American Academy of Orthopaedic Surgeons
American Orthopaedic Association
National Institutes of Health
International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
International Cartilage Repair Society
Orthopaedic Research Society
American Shoulder and Elbow Surgeons
European Society for Sports Traumatology, Knee Surgery and Arthroscopy
International Society for the Study of the Lumbar Spine

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Common Important Terms

Clinical Trials. A type of study involving human volunteers to assess the safety and efficacy of a new treatment, drug, or medical device.
Clinical Research Organizations (CROs). Organizations that provide services to pharmaceutical and biotechnology companies to help them conduct clinical trials.
Institutional Review Board (IRB). A committee that reviews, approves, and monitors research involving human participants to ensure the rights and welfare of the participants are protected.
Investigational New Drug (IND). A drug or biological product intended for use in clinical trials that has not yet been approved for marketing by the U. S. Food and Drug Administration (FDA).
Good Clinical Practices (GCP). A set of standards that describe the responsibilities of sponsors, investigators, and monitors involved in clinical trials.
Data Management. The process of collecting, organizing, and analyzing data from a clinical trial.
Statistical Analysis. The process of analyzing data from a clinical trial to determine whether the results are statistically significant.

Frequently Asked Questions

What is the role of an Orthopedic Clinical Research Coordinator?

An Orthopedic Clinical Research Coordinator is responsible for coordinating and managing clinical research projects related to orthopedic medical conditions. This includes managing research timelines, recruiting and tracking participants, collecting and analyzing data, and ensuring compliance with regulatory standards.

What qualifications are needed to become an Orthopedic Clinical Research Coordinator?

To become an Orthopedic Clinical Research Coordinator, one must typically have a bachelors degree in health sciences, a masters degree in public health or a related field, and experience working in clinical research. Additionally, certification as a Clinical Research Coordinator (CRC) may also be required.

What responsibilities do Orthopedic Clinical Research Coordinators have?

Responsibilities of an Orthopedic Clinical Research Coordinator include designing and implementing clinical trials, recruiting and screening participants, gathering data, tracking results, and responding to inquiries from the research team and regulatory bodies.

How many hours a week do Orthopedic Clinical Research Coordinators typically work?

Orthopedic Clinical Research Coordinators typically work around 40 hours per week, depending on the needs of their particular research project.

What is the expected salary range for Orthopedic Clinical Research Coordinators?

Salaries for Orthopedic Clinical Research Coordinators vary depending on experience and location but typically range between $50,000 and $70,000 per year.

Web Resources

Clinical Research Teams | Department of Orthopaedic Surgery ortho.stanford.edu
Orthopaedic Clinical Research - Children's Hospital of Philadelphia www.chop.edu
Full-time, Paid, Clinical Research Coordinator, Orthopedic www.gs.columbia.edu