Clinical Research Associate Job Description

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Clinical Research Associate Job Description

Job descriptions
Healthcare and Medical

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

Assist with investigator site identification and distribution and collection of Confidential Disclosure Agreements (CDAs).
Collect and review the Essential Documents and GreenLight Form to enable sites to be set up and activated.
Prepare Investigator Site Files and customize for country and Sites.
Manage access for Investigator Site ElectronicSystems for internal and external study team members.
- Communicate Institutional Research Board/IndependentEthical Committee (IRB/IEC) Submission/Approval status with investigator sites and track status.
- Management, QC and filing of Essential Documents in TMF/eTMFthat have been collected from investigator sites.
- Prepare, reconcile, and archive trial-related documents at study closure.

Requirements & Skills 2

Previous clinical research experience (eg. CTA, site coordinator, etc.)
Excellent written and verbal English communication skills; fluent in host country language
Strong computer skills, proficiency with MS Office Word/Excel
Undergraduatedegree in Nursing, Life Sciences, or equivalent work experience
- Experiencewith CTMS/eTMF/EDC systems
- Goodknowledge of ICH-GCP
- Ability to be flexible and multitask

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

Coordination of multiple studies, including coordination with various departments, patients, and locations. Working within various systems to capture all data (electronic databases, patient records, patient payments, and status logs).
Completion and maintenance of regulatory documentation (amendments to protocol, laboratory binder, source documents).
Maintain the position as Program Administrator for the Headache & Facial Pain Headache Fellowship Program for all current Headache Fellows in New Innovations.
Ordering as-needed books, supplies, educational registrations, and planning graduation awards and certificates.
Screen internal and outside mail and screen telephone messages.
- Compose correspondence and reports and obtain signatures promptly as required for the division.
- Work with minimal supervision with planning, organizing, and coordinating multiple work assignments and establish and maintain effective working relationships with others, and effectively and professionally communicate sensitive information and maintain confidentiality.
- Performs other duties as assigned.

Requirements & Skills 3

This position requires a Bachelor's degree in a field directly related to the program responsibilities and one year of professional experience; or a Master's degree in an area of specialization appropriate for the program.
Clinical Research experience.

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

Manage in-house testing of R&D prototype instruments, including recruitment of subjects, maintenance of the study log, and status reports.
Work collaboratively with R&D, Clinical Affairs, and Marketing to support beta test activities, including the drafting of beta plans, beta protocols, and beta final reports.
Assist Clinical Affairs in drafting clinical procedures and protocols to ensure that clinical studies are completed professionally and promptly. Assure that accurate records are maintained and provide periodic reports, where appropriate.
Assist with training of clinical investigators to ensure the appropriate operation of instrumentation.
Represent CA/RA Department on Project Teams, where appropriate.
- Conduct clinical site audits as necessary to support clinical studies.
- Conduct clinical studies in a manner that ensures compliance with the company’s SOPs, Institutional Review Board oversight, and following clinical practices.
- Perform others duties, as assigned.

Requirements & Skills 4

Bachelor’s degree in an appropriate discipline or equivalent. Work experience may be considered instead of a Bachelor’s degree.
Must have excellent communication skills, both written and oral, and must be computer literate.

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

Responsible for site management and clinical monitoring by contractual agreements, department guidelines, SOPs, and applicable international, federal, and state regulations and guidelines.
Act as the main line of communication between the sponsor and the investigator.
Verifying that all research staff, facilities, and investigational products have adequate qualifications and resources and these remain adequate throughout.
Responsible for the safety and proper conduct throughout the trial.
Verifies that source data/documents and other trial records are accurate, complete, and maintained.
- Adverse events, concomitant medications, and intercurrent illnesses are reported by the protocol on the CRFs.
- Communicates deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator.
- Performs other related duties incidental to the work described herein.

Requirements & Skills 6

Must possess superior analytical and creative thinking skills
Excellent attention to detail and the ability to keep detailed, accurate records
Strong written and verbal communication skills
Advanced organizational and planning skills
Proficiency in MS Word and Excel programs
- Completion of an allied health degree (e.g., Respiratory Therapy, Radiology Technology, and Licensed Practical Nurse) or an Associate’s degree in Clinical Trials Research related curriculum plus a minimum of one year of healthcare experience preferred.
- Requires sitting and standing associated with a normal office environment
- Manual dexterity needed for using a calculator and computer keyboard

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

Assists in the execution and monitoring of internal clinical studies
Assists in the execution and monitoring of external clinical studies
- Assists in the identification and qualification of external clinical sites
- Assists in the development and maintenance of operating procedures
- Communicates effectively the outcomes of the study to cross-functional teams

Requirements & Skills 7

Associate degree required. Bachelor's degree is preferred
2 years of experience in conducting clinical research or laboratory experience in biology or a related field is required with an Associate degree. No previous experience is necessary with a bachelor's degree
instead of an associate degree, a minimum of four years of experience in conducting clinical research or laboratory experience in biology or a related field is required

Job summary 8

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

Duties & Responsibilities 8

Monitors activities conducted by clinical investigative sites.
Conducts site qualification, initiation, interim monitoring, and study closeout visits for Phase 1-4 studies by applicable regulations, Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and business processes.
Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites.
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
Ensures the safety and protection of study subjects through compliance with the study monitoring plan, SOPs, ICH Guidelines, and applicable regulations.
Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
- Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders.
- Maintain and complete own expense reports as per local and applicable guidelines.
- Identifies evaluates, and recommends new/potential investigators/sites on an ongoing basis.

Requirements & Skills 8

Appropriate tertiary qualification, health-related (e.g., Medical, Scientific, Nursing) preferred.
Minimum of 1 year of clinically-related experience, of which 6 months is preferable in clinical research monitoring. Experience in on-site monitoring of investigational drug or device trials is required
Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines, and applicable regulations.
- Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.
- Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study-related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.
- Demonstrated business ethics and integrity.

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

Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP, and/or Good Pharmaco-epidemiology Practice (GPP) and protocol compliance.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
Routinely reviews the Investigator Site File (ISF) for accuracy, timelines, and completeness.
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities/communication to ensure project objectives, deliverables, and timelines are met.
- May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
- Prepares for and attends Investigator Meetings and/or sponsors face-to-face meetings.
- Participates in global clinical monitoring/project staff meetings/ bid defense meetings (inclusive of Sponsor representation, as applicable).

Requirements & Skills 9

Relevant degree
Minimum 3 years of experience as a Clinical Research Associate
Oncology experience required
RBM experience is be preferred
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation, and interpersonal skills
- Basic level of critical thinking skills expected
- Fluency in German and English language

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

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.

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