Clinical Research Coordinator Job Description
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The Clinical Research Coordinator coordinates, assists, and implements clinical research projects at the client. Under general direction, performs duties associated with coordinating study initiation, investigators' training, and implementing study protocols. In addition, the Clinical Research Coordinator will assist ACR's departmental projects including education, quality improvement, and other human research support services.
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Job summary 2
We are currently seeking a Clinical Research Coordinator to manage all aspects of conducting clinical research trials. This position is responsible for working collaboratively with multidisciplinary teams, including research, hospital, and clerical staff to efficiently organize the coordination of clinical trials. A Clinical Research Coordinator will aid with the screening, recruiting, consenting, and enrollment of patients in clinical trials as well as aiding with data collection/management and ensuring protocol compliance.
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Job summary 3
A Clinical Research Coordinator manages protocols to ensure the safety of patients and the quality of clinical trial data. Prepares and submits Institutional Review Board (IRB) paperwork and maintains all related regulatory document submissions.
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Job summary 4
We are looking for candidates with medical backgrounds and excellent interpersonal skills for the position of Clinical Research Coordinator. Clinical Research Coordinators are responsible for administering questionnaires and subject material, adhering to regulatory trial standards, and participating in subject recruitment efforts, among other duties. Clinical Research Coordinators need to engage with research subjects, explain what is expected of them, and understand their concerns, requiring excellent interpersonal and communicative skills.
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The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial by the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations.
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The Clinical Research Coordinator will be responsible for coordinating and assuring the integrity of all activities associated with conducting a clinical trial. S/he will ensure compliance with local, state, and federal regulatory requirements.
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A typical Clinical Research Coordinator performs a variety of administrative tasks in support of clinical trials and assists in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies.
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The Clinical Research Coordinator (CRC) will manage all aspects of a clinical behavioral research study. The CRC will assign and coordinate activities of the study to ensure protocol, regulatory, standard operating procedures (SOP), and Good Clinical Practice (GCP) compliance.
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The selected candidate will help coordinate among Clinical Research Coordination team members conducting investigational clinical studies by Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.
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Job summary 10
Under the direction of the Director of Clinical Services and Principle Investigator (PI), the Clinical Research Coordinator in his/her designated specialty is responsible for the promotion of good clinical practices and medical care in the conduct of the clinical investigation. This will be performed by ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of data generated at the site, and directing the conduct of the clinical investigation according to federal and state regulations and guidance documents. By the very nature of the profession, the level of the assignment will call for a maximum degree of knowledge, professional judgment, and ingenuity.
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Frequently asked questions
What are 10 things clinical research coordinators do?
Clinical Research Coordinators (CRCs) play a pivotal role in managing and coordinating clinical trials, which can involve various responsibilities. Here are ten key tasks a CRC might perform:
Study Protocol Management: CRCs ensure clinical trials are carried out according to the approved protocol. They are responsible for understanding the study design and ensuring all activities adhere to it.
Regulatory Compliance: CRCs help ensure the clinical trial complies with relevant regulations and guidelines, such as those from the FDA or local Institutional Review Boards (IRBs).
Patient Recruitment and Screening: They may be involved in recruiting participants for trials, which includes obtaining informed consent and screening participants to ensure they meet the study's eligibility criteria.
Data Collection and Management: CRCs are responsible for the accurate collection, recording, and storage of data from clinical trials. This might involve using electronic data capture systems or maintaining paper records.
Patient Care Coordination: CRCs often coordinate care for trial participants, which can include scheduling appointments, ensuring tests and procedures are completed, and monitoring participants' health and safety.
Communication: CRCs communicate with a range of people, including patients, healthcare professionals, and research investigators. They also liaise with study sponsors and regulatory authorities.
Safety Reporting: They monitor and report any adverse events or unanticipated problems involving risks to participants or others during a clinical trial.
Staff Training: CRCs might train other staff members on study protocols and procedures to ensure correct and consistent data collection.
Quality Control: They check data entries, case report forms, and other documents for accuracy and completeness to maintain the quality of the research data.
Administrative Tasks: CRCs may also manage administrative duties related to the clinical trial, such as budgeting, managing resources, and organizing meetings.
Remember, the specific duties of a CRC can vary widely based on factors like the type of clinical trial, the size and nature of the research institution, and the regulatory context.
What are clinical research coordinator skills?
Clinical research coordinators (CRCs) need a variety of skills to effectively perform their roles, which involve managing and coordinating clinical trials. These skills include:
Organizational Skills: CRCs manage various aspects of clinical trials, such as patient schedules, data collection, and regulatory documentation. Excellent organizational skills are essential to handle these tasks efficiently.
Attention to Detail: Clinical trials require precise data collection and careful adherence to protocols. A keen eye for detail helps ensure the accuracy of data and the integrity of the trial.
Communication Skills: CRCs communicate with a range of individuals, including patients, healthcare professionals, researchers, and regulatory bodies. They need excellent written and verbal communication skills to convey information effectively and build strong relationships.
Interpersonal Skills: They often interact with study participants, so they need good interpersonal skills to establish trust and rapport. Empathy and sensitivity are particularly important when working with participants who may be dealing with serious health issues.
Problem-Solving Skills: CRCs may face a variety of challenges during a clinical trial, from recruitment issues to data discrepancies. Strong problem-solving skills can help them find effective solutions.
Understanding of Clinical Research: A solid grasp of clinical research principles and procedures is essential. This includes understanding research design, ethical guidelines, regulatory standards, and data management practices.
Data Management Skills: CRCs often collect, record, and manage a large volume of data. They need to be comfortable with data management systems and have a good understanding of data privacy regulations.
Ethical Awareness: They must adhere to strict ethical guidelines to protect the rights, safety, and well-being of trial participants. An understanding of research ethics, including informed consent and confidentiality, is crucial.
Flexibility and Adaptability: Clinical trials can be unpredictable, with unexpected challenges or changes. The ability to adapt and respond effectively to these changes is important.
Knowledge of Medical Terminology: Familiarity with medical and scientific terminology is beneficial in understanding study protocols and communicating with healthcare professionals and researchers.
These skills help CRCs ensure the smooth operation of clinical trials, safeguard the well-being of participants, and contribute to the advancement of medical knowledge and treatments.
