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.

Duties & Responsibilities 1

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Requirements & Skills 1

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.

Duties & Responsibilities 2

Requirements & Skills 2

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).

Duties & Responsibilities 3

Requirements & Skills 3

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.

Duties & Responsibilities 4

Requirements & Skills 4

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.

Duties & Responsibilities 5

Requirements & Skills 5

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.

Duties & Responsibilities 6

Requirements & Skills 6

Job summary 7

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.

Duties & Responsibilities 7

Requirements & Skills 7

Job summary 8

We are looking for a Clinical Research Associate to join our team.

Duties & Responsibilities 8

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.

Duties & Responsibilities 9

Requirements & Skills 9

Job summary 10

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.

Duties & Responsibilities 10

Requirements & Skills 10

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