Clinical Research Associate Job Description

Clinical Research Associate Job Description

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Clinical research associate provides instructions to Clinical Research Coordinators (CRC), Regulatory staff, Investigators, and other research team members regarding AHRI policies and standard operating procedures, and Good Clinical Practice guidelines.

Clinical Research Associate Duties & Responsibilities

To write an effective clinical research associate job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical research associate job description templates that you can modify and use.

Sample responsibilities for this position include:

The Clinical Research Associate (CRA) monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols
Take part and initiate processes, procedures in order to further develop the skills and capacity of the clinical research team
Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects
Performing necessary functions as approved by the company, for the conduct of clinical research
Prepare/monitor clinical development plans
Oversee review and approval of protocols
Review/approve informed consent document
Plan and track study milestones and study data
Visit sites/investigators
Execute clinical study agreements

Clinical Research Associate Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Clinical Research Associate

List any licenses or certifications required by the position: ACRP, SOCRA, CRA, GCP, ICH, CCRP, CCRA, CCRC, CRP, BLCS

Education for Clinical Research Associate

Typically a job would require a certain level of education.

Employers hiring for the clinical research associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Education, Medical, Nursing, Science, Health, Life Science, Healthcare, Health Care, Technical, English

Skills for Clinical Research Associate

Desired skills for clinical research associate include:

ICH and local regulatory authority regulations regarding drug
Clinical research process
Budget management
Microsoft Office and the ability to learn appropriate software
Clinical research
Electronic data capture
Phases of clinical trials
Good Documentation Practices
Good Clinical Practice guidelines
Current GCP/ICH guidelines applicable to the conduct of clinical research

Desired experience for clinical research associate includes:

Review/approve SAP/amendments
Review SAE reports
Review clinical data
Conduct safety/efficacy review of clinical data (signal detection)
Review protocol deviations
Develop and execute high-quality, realistic, cross-functional, clinical trial plans using best practice management standards and methodologies

Clinical Research Associate Examples

1

Clinical Research Associate Job Description

Job Description Example
Our innovative and growing company is hiring for a clinical research associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical research associate
  • Develops and disseminate Requests for Proposals from Service Provider’s and will manage Service Providers including training and oversight, and serves as the primary point of contact for SPs
  • Draft and coordinate the review of study-related documents including protocols, informed consent forms, case report forms, monitoring plans, investigator brochures, and clinical study reports
  • Maintain program timelines, develops study budgets, and coordinates review of data listings and prepares interim/final clinical study reports
  • Contribute to development of abstracts, presentations, and manuscripts and may contribute to the development of clinical trial management best practice processes and SOPs
  • Write protocols, amendments, case record forms, clinical reports and other documents relevant for dedicated clinical investigations
  • Assists the study team(s) to deliver the clinical study within agreed timelines
  • Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors
  • Provides oversight of Clinical CRO Investigator background checks
  • Assists in oversight of vendor shipment of clinical supplies
  • Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP
Qualifications for clinical research associate
  • Support site identification, selection, recruitment & qualification, and initiation
  • Travel to study sites for meetings and monitoring visits upon request (ca
  • The SCRA ensures that activities are conducted in accordance with the internal quality system and external guidelines and regulations
  • Reviews Clinical Monitoring Reports and correspondence related to Pre-Study and Initiation Visits and follows-up with Clinical CRO to resolve open action items
  • Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager
  • Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System
2

Clinical Research Associate Job Description

Job Description Example
Our growing company is looking to fill the role of clinical research associate. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical research associate
  • Maintain awareness of current issues in clinical research by reading relevant literature and attending industry meetings and other training opportunities
  • Performing basic screening of patients for study enrollment
  • Enrolling patients in studies
  • Performing patient follow-up visits
  • Documenting study procedures in source clinic charts
  • Updating and maintaining required logs and charts
  • Organizing work area
  • Performing audits for quality control purposes
  • Processing and sending lab specimens per protocol specifications
  • Completing case report forms ensuring accuracy of data and reporting of adverse events to sponsor
Qualifications for clinical research associate
  • Ability to prioritize in a fast paced environment, generate enthusiasm for new processes and technology and a desire for learning new skills is a plus
  • Certification as a Medical Assistant is preferred
  • Exercises independent judgment in providing assistance to the Administrator, nurses or other company official
  • Functions as a clinical assistant to the Research nurses
  • Maintains a filing system(s) with proper indexing and ongoing removal of inactive material
  • Assists with planning, preparation, review and assembly of regulatory documents, submissions to IRB and sponsor to assure compliance with approved FDA and GCP/ICH guidelines
3

Clinical Research Associate Job Description

Job Description Example
Our company is searching for experienced candidates for the position of clinical research associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical research associate
  • Being familiar with the protocol, case report form, informed consent, source documentation and patient diary (when applicable), for the research studies
  • Ensuring study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner
  • Generating reports for supervisor on patient enrollment and tracking
  • Maintaining accountability of own ongoing professional growth and development
  • Maintaining strict confidentiality of patients, employees and company information at all times and adheres to HIPAA Guidelines
  • Performing other duties not specifically listed in this job description as assigned
  • Support the successful migration/indexing of clinical study trial Master files into the new eTMF system (Pharma TMF) through the provision of support to the CPSSO Study Accountable Person (SAP) and their Study Team members Clinical Development Scientists and Clinical Data Scientists (as appropriate)) to agreed quality and data integrity standards
  • Provide support to the CPSSO clinical development or data scientist team members as needed
  • Serve as point of contact for the migration/indexing study teams for TMF matters, and liaise with the other TMF Subject Matter Experts (SMEs) and process owners to help their understanding of requirements and associated solutions to ensure the migrated and indexed TMFs are inspection ready
  • Support the analysis and identification of business problems/opportunities that may arise during the migration/indexing and, support the implementation of high quality solutions
Qualifications for clinical research associate
  • Maintains up-to-date records of continuing education credits earned, if applicable
  • Consistently demonstrates problem solving and communication skills while interacting with co-workers, hospital employees and customers
  • Works with the Research Center Coordinators to manage the development and tracking of budget, intra-hospital payments, investigator payments and patient payments
  • Assists with coordination of residents, pharmacy students, externs, interns, technician students, and volunteers
  • Works with Research Center staff to provide departmental and intradepartmental staff and patient education for clinical trials
  • Meets with sponsors and monitors of investigational studies being conducted to assist in the implementation, conduct and monitoring of all ongoing studies
4

Clinical Research Associate Job Description

Job Description Example
Our company is hiring for a clinical research associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical research associate
  • Coordinates with Principal Investigator, department, and central administration to help ensure that clinical research and related activities are performed in accordance with Federal regulations and other sponsoring agency policies and procedures
  • Patient screening and recruitment
  • Patient enrollment
  • Maintaining and dispensing study product and supplies
  • Completing and ensuring the quality of case report forms
  • Maintaining source documents
  • Ensuring site quality
  • Responding to queries in a timely manner
  • Assist in preparation of protocols and documentation for clinical studies, entailing communication with consultants such as surgeons, radiologists and outside statisticians
  • Assist in the IRB/EC application process, including review of informed consent / HIPAA forms for conformance to pertinent government regulations
Qualifications for clinical research associate
  • Collect, process, and ship lab samples per study protocol, as needed
  • Collects patient specific data and/or laboratory results
  • Assist with audits performed by research sponsors and the FDA
  • Assists in coordination of marketing of Research Center services
  • *Prefers MA- would like research experience, flexibility in schedule is a must
  • University degree (Life Science)
5

Clinical Research Associate Job Description

Job Description Example
Our growing company is hiring for a clinical research associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical research associate
  • Assist Madigan research investigators and its collaborators, as directed by DCI leadership, in the preparation of research proposals and protocols involving human subject clinical research coordination
  • Contribute to overall data management such as case report form design, edit check review, data clarification process and evaluating and analyzing clinical data
  • Recruit, qualify and train investigators and clinical site personnel (and laboratories, as applicable) for study participation
  • Assist with contract and budget preparation and negotiations
  • Coordinate activities of investigators and clinical site personnel to ensure compliance with the protocol and overall clinical objectives
  • Coordinate the organization of study regulatory files, inventory and all related study materials and supplies
  • Assure data integrity through proper on site monitoring, verification of source records, documentation of protocol deviations, and completion of written reports, in accordance with department Standard Operating Procedures (SOPs)
  • Communicate with clinical sites to expedite the exchange of information and to ensure that clinical studies are kept on schedule and within budget
  • Assist with the implementation of investigator meetings and general clinical meetings (as applicable)
  • Contribute to obtaining government approvals and preparing progress reports for clinical studies
Qualifications for clinical research associate
  • Excellent communication skills both in English and Turkish
  • Good in planning and organization
  • Good knowledge of MS Windows and MS Office
  • Having driving license
  • A Medical Assistant certification OR BA/BS in a science related field OR 1+ years of research experience, or an equivalent combination of education and experience, is required
  • Must be proficient with Microsoft office applications (Outlook, Word and Excel) internet based applications

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