Clinical Research Associate Job Description
Job summary 1
The Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with sites, the Clinical Research Associate will ensure the success of clinical trial operations and management.
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Job summary 2
We are looking for a Clinical Research Associate to join our Clinical Operations department. You will be responsible for site identification and assisting with the distribution and collection of essential documents by the SOP and ICH-GCP. You will support submissions to local regulatory authorities, localization of patient-facing materials, and assembly of the Investigator Site File.
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Job summary 3
A Clinical Research Associate will coordinate multiple complex clinical trial studies independently. Will manage multiple patients enrolled in clinical trial studies and guide them through study visits while overseeing all aspects of the clinical trial process which includes: managing and handling laboratory supplies and data; participating in subject identification and recruitment; overseeing the consent process; gathering, transcribe, and enter study data into sponsor databases; gather and handle biospecimens; create source documents to collect study data; ensure quality control, compile reports for regulatory compliance and maintenance while complying with clinical trial study requirements. The Clinical Research Associate will also troubleshoot to avoid protocol deviations. Will complete all training requirements for each study, attend study meetings as necessary, and participate in monitoring visits and audits. Completion and maintenance of all regulatory documentation (startup packets, training, logs, amendments, continuing reviews).
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Job summary 4
The Clinical Research Associate is responsible for supporting in-house testing of R&D prototype instruments. The Clinical Research Associate may also assist with training external clinical study sites on the use of prototype and commercially available instrumentation. The Clinical Research Associate may assist with the planning and execution of beta studies, including the preparation of beta plans, beta protocols, and final beta reports. The Clinical Research Associate may participate as a member of Project Teams, as assigned, representing the Clinical/Regulatory Affairs department.
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Job summary 5
You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Clinical Research Associate, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
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Job summary 6
The Clinical Research Associate (CRA) has an important task within the clinical trial process. He or she has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data is accurate, complete, and verifiable from source documents. Most importantly, the CRA makes sure that the conduct of the trial complies with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements. This is an exempt position that directly reports to the Chief Medical Officer.
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We are recruiting a new Clinical Research Associate to join our Clinical Affairs team. In this role, you will be involved in designing, executing, and monitoring internal and external clinical studies in support of our products and pipeline. Your efforts in this manner will adopt, adhere and follow standard procedures in executing experiments, evaluations, documentation, and reporting of results/findings. You should be a steward of quality and excellence. Successful and timely completion of clinical studies directly impacts the ability to meet product development goals and product introduction timelines.
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Job summary 8
We are looking for a Clinical Research Associate to join our team.
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Requirements & Skills 8
Job summary 9
The Clinical Research Associate independently performs investigational site qualification, interim, and site close-out monitoring visits by our Standard Operating Procedures. Completes and writes applicable visit reports and follow-up letters. Independently performs site initiation visits including conducting site and study-specific training by our Standard Operating Procedures. Writes site initiation visit reports and follow-up letters. Responsible for collecting and completing associated documentation during visits.
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A Clinical Research Associate manages an assigned set of multiple research protocols to assure efficiency and regulatory compliance of the protocol, attending the clinic as needed, with mentorship by experienced staff. Responsible for compilation, registration, and submission of data. Maintains a system for effective data flow associated with research protocols.
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Frequently asked questions
What is the role of a clinical research associate?
A Clinical Research Associate (CRA) is involved in various stages of a clinical trial, acting as a liaison between the site conducting the trial and the sponsor, such as a pharmaceutical or medical device company. They play a key role in ensuring that clinical trials are conducted in compliance with the clinical trial protocol, good clinical practice (GCP) guidelines, and regulatory requirements. Here's a general overview of their typical responsibilities:
Site Identification and Evaluation: CRAs may help in identifying potential sites for clinical trials and evaluating their suitability. This can involve assessing the site's facilities, staff, patient population, and past performance in trials.
Site Initiation: They conduct site initiation visits to train site staff on the trial protocol, procedures, and regulatory requirements. They also ensure that the site is ready to start enrolling patients and conducting the trial.
Monitoring: One of the main duties of a CRA is monitoring the conduct of the trial at the site. This includes regular visits to the site to review source documents, compare them to case report forms (CRFs), and verify that the trial is being conducted in compliance with the protocol and GCP guidelines.
Data Management: CRAs ensure that the data collected from clinical trials are accurate, complete, and verifiable from source documents. They may also help in resolving any data queries that arise.
Safety Reporting: They ensure that any adverse events or safety issues are properly reported and followed up, both at the site and to the sponsor and regulatory authorities as required.
Communication: They act as the main line of communication between the site and the sponsor, answering any questions from the site, providing updates to the sponsor, and escalating any issues as needed.
Site Close-Out: At the end of the trial, CRAs conduct site close-out visits to ensure that all trial activities are completed, all data queries are resolved, and all investigational products and trial materials are accounted for and returned or disposed of as appropriate.
Compliance: Throughout the trial, CRAs are responsible for ensuring that the trial is conducted in compliance with the protocol, GCP guidelines, and applicable regulatory requirements.
Documentation: They ensure that all required trial documentation is in place and maintained appropriately, including the trial master file (TMF).
Remember that the specific duties of a CRA can vary depending on the organization they work for, the specific trials they work on, and their level of experience.
Who does a clinical research associate work with?
A Clinical Research Associate (CRA) works with a variety of individuals and teams involved in clinical trials, both within their own organization and externally. Here are some of the key groups they interact with:
Clinical Research Coordinators: These are often the primary contact persons at the site conducting the trial. CRAs work closely with them to monitor the trial and resolve any issues.
Principal Investigators: These are the individuals, typically doctors or other healthcare professionals, who are responsible for conducting the clinical trial at a site. CRAs interact with them to ensure the trial is being conducted in accordance with the protocol and regulatory requirements.
Sponsor's Clinical Team: CRAs are often employed by or work on behalf of the sponsor of the trial, such as a pharmaceutical or medical device company. They interact with various teams within the sponsor's organization, such as the clinical operations team, data management team, and safety team.
Regulatory Authorities: Depending on their role and the specific trial, CRAs may interact with regulatory authorities such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
Patients: While direct interaction with patients in the trial is usually limited, CRAs may occasionally interact with patients, such as during site visits.
Contract Research Organizations (CROs): Many sponsors outsource their clinical trials to CROs. If a CRA is employed by a CRO, they would work with the teams within the CRO and represent the sponsor at the trial sites.
Ethics Committees / Institutional Review Boards (IRBs): These are the bodies that approve and oversee the ethical conduct of the trial. CRAs may interact with them to submit necessary documentation and address any questions or concerns they have.
Pharmacovigilance / Safety Team: CRAs often interact with these teams to ensure that any adverse events or safety issues are properly reported and followed up.
Remember that the exact nature and extent of a CRA's interactions with these groups can depend on many factors, including the size and type of their organization, the specific trials they work on, and their level of experience.
