Senior / Clinical Research Associate Job Description
Senior / clinical research associate
provides oversight of clinical research sites compliance with ICH/Good Clinical Practices (GCP), governing SOPs (standard operating procedures) and clinical study protocols.
Senior / Clinical Research Associate Duties & Responsibilities
To write an effective senior / clinical research associate job description, begin by listing detailed duties, responsibilities and expectations. We have included senior / clinical research associate job description templates that you can modify and use.
Sample responsibilities for this position include:
Work collaboratively with the study teams with the review, revision and writing of protocols, Case Report Forms (CRF) and other required documents for clinical research studies
Work with Clinical Research Organizations (CRO) and study teams to write, review and revise Informed Consent Forms (ICF)
Support the management of the daily operations of clinical research studies to ensure timely start-up, accrual, maintenance and close-out of assigned studies
Assist with the training and supervision of newly hired Clinical Research Associates (CRAs)
Reviewing informed consent forms and other Trial Master File (TMF) documents, insuring that all regulatory requirements are met
Performing site visits as needed, insuring the clinical trial is being performed according to ICH/GCP guidelines and meeting the protocol requirements
Planning, coordinating, and facilitating investigator meetings
Communicating with study centers, addressing issues and disseminating study trial information when needed
Training investigators, monitors and site personnel to ensure appropriate collection and reporting of non-serious and serious adverse events
Assisting with data flow and query resolution
Senior / Clinical Research Associate Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior / Clinical Research Associate
List any licenses or certifications required by the position: CCRA, CCRP, CCRC, GCP, ACRP, CRA
Education for Senior / Clinical Research Associate
Typically a job would require a certain level of education.
Employers hiring for the senior / clinical research associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Health, Nursing, Pharmacy, Medical, Education, Biological Science, Life Sciences, Life Science, Science, Health Care
Skills for Senior / Clinical Research Associate
Desired skills for senior / clinical research associate include:
Budget management
Clinical research process
Electronic data capture
Current GCP/ICH guidelines applicable to the conduct of clinical research
Clinical research
Phases of clinical trials
Good Documentation Practices
Current GCP/ICH & country clinical research law & guidelines
EDC systems and IVRS
Microsoft Office and the ability to learn appropriate software
Desired experience for senior / clinical research associate includes:
Requesting and managing clinical supplies, including coordinating the shipment of the clinical supplies
Managing blinded read activities
Managing vendors and consultants
Insuring that all project information is up to date in CTM
Tracking enrollment for each site
Creating and maintaining Trial Master File
Senior / Clinical Research Associate Examples
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Senior / Clinical Research Associate Job Description
Job Description Example
Our company is looking to fill the role of senior / clinical research associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior / clinical research associate
- Coordinates the review of applicable study-specific essential documents including informed consent documents, case report forms (CRFs), subject directed recruitment materials
- Coordinates the processes of Due diligence, site contracting and purchase order preparation invoice tracking
- Coordinates the collection of all the essential documents needed for the investigator initiation package (IIP)
- Ensures management of retain samples
- Ensure all clinical site personnel are trained to study protocol, procedures, and local regulations
- Ship investigational devices and performs device accountability, as applicable
- Prepare for and execute on-site qualification, study initiation, interim monitoring and close-out visits at clinical sites as necessary to ensure study requirements are being fulfilled
- Conduct monitoring visits in compliance with the study specific Monitoring Plan, Standard Operating Procedures, Good Clinical Practices (GCP) and applicable government regulations and guidelines
- Communicate clearly with clinical sites
- Maintain responsibility for site management for pre- and post-market studies ensuring successful conduct of clinical programs, and cross- functional strategies
Qualifications for senior / clinical research associate
- Knowledge of relevant medical device regulatory requirements
- Serve as a liaison for clinical trial agreement (CTA) and budget negotiations
- Ensure maintenance of study master file to ensure compliance with internal procedures, and applicable country-specific regulations
- Track progress of clinical studies with regard to budget, study milestones, and deadlines
- Perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support assigned product lines and related clinical studies, staying informed about applicable clinical landscapes and trends
- Participate in study audits, as applicable
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Senior / Clinical Research Associate Job Description
Job Description Example
Our growing company is looking to fill the role of senior / 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 senior / clinical research associate
- Manage study sites and train the clinical site staff to ensure protocol and regulatory compliance and quality of data
- Independently oversee external CRAs, providing clear communication and direction with regards to the clinical protocol and general trial support
- Participate in the CRO selection and management
- May assist in or be responsible for development of protocols, informed consents, case report forms, monitoring plans, edit specifications, and clinical study reports
- Assist with projection and management of clinical supplies
- Coordinate and/or participate in investigator meetings
- Responsible for updating study timelines and metrics
- Responsible for listing review and resolution of queries during database lock and in preparation of final study reports
- Participate in and/or chair meetings or conference calls with CROs, CRAs and cross-functional study teams
- Provide mentoring to CRAs and Clinical Trial Assistants (CTA’s)
Qualifications for senior / clinical research associate
- 5+ years of postgraduate pharmaceutical experience
- Experience with late stage drug development preferred
- Bachelor's Degree in a related field (e.g., biological, medical, public health, physical sciences, engineering) is required
- Ability to work effectively on a cross-functional team is desired
- Must have the functional and technical knowledge and skills to do the job at a high level of accomplishment
- Must possess ability to solves difficult problems with effective solutions
3
Senior / Clinical Research Associate Job Description
Job Description Example
Our company is growing rapidly and is hiring for a senior / clinical research associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior / clinical research associate
- Track clinical data, regulatory documents, patient enrollment, and data resolutions to assist the timely completion of clinical studies
- Assist in the creation of model informed consents, case report forms, instruction manuals, and monitoring tools
- Assure regulatory compliance of investigational sites with company SOP’s, FDA, and ICH guidelines
- Write visit reports and follow-up letters to investigators
- Set up files, archive study documentation, correspondence and completed case report forms
- Enhance professional growth and development through participation in education programs, current literature, in-service meetings and workshops
- Provide technical and administrative assistance to the clinical department
- Site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
- Involvement in Feasibilities and Start up of studies assigned
- Preparation of study documents and support in submissions
Qualifications for senior / clinical research associate
- Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans
- Experience in selection and management of vendors/CROs (Central Lab, IVRS, EDC)
- Bachelor’s degree in a relevant scientific discipline or equivalent
- At least 5 years of relevant clinical experience with at least 2 years in a CRA functional role in the pharmaceutical industry, with global study experience
- Able to perform assignments with general instructions
- Able to solve complex problems, prioritize multiple tasks, plan proactively and accomplish goals within project
4
Senior / Clinical Research Associate Job Description
Job Description Example
Our company is searching for experienced candidates for the position of senior / 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 senior / clinical research associate
- Assist in the preparation of study specific procedures and guidelines
- Responsible for all aspects of Site Management and Monitoring of clinical studies from initiation through close out, including onsite visits and remote monitoring
- Completion of visit reports and tracking in CTMS and other systems within requested timelines
- Working with a local and international project teams
- Responsible for data review as per project specifications
- Review and maintenance of regulatory documents as per study and local requirements
- Liaise between the sites and project teams and establish good communication and relationship
- Assist with training, mentoring, and development of new employees, co-monitoring
- Authorized to work in the US for any employer
- Be less than one hour from a major airport
Qualifications for senior / clinical research associate
- University degree in a science related field or are a certified health professional
- Degree in pharmacy, life science or related field
- Ability to mentor and train other monitors in a positive and effective manner
- Ability to evaluate medical research data and proficient knowledge of medical terminology
- Ability to multi-task and prioritize multiple high-priority projects, site questions, and clinical team inquiries while managing responsibilities and deadlines
- Participates in investigator meetings as necessary
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Senior / Clinical Research Associate Job Description
Job Description Example
Our company is hiring for a senior / 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 senior / clinical research associate
- Consistently completes site monitoring reports
- For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out
- Ensure clinical trial management systems containing all site-specific information are maintained and kept current
- Responsible for coaching and mentoring CRAs and providing input into their development
- May participate/lead in global/local task forces and initiatives
- Provide leadership in representing monitoring interests to the study conduct team
- Take a leadership role in developing monitoring organisation characterised by process standardisation, best practice sharing, and continuous improvement
- Provide training for new monitoring personnel and contribute to their performance appraisals, as appropriate
- Individual contributor who demonstrates diligent and self-motivated approach to working in an off-site and independent work environment
- Participate in reviewing protocols, amendments, investigator brochures, Informed Consent Forms (ICFs) and CRFs and facilitate Institutional Review Board (IRB) submission, queries, and approval
Qualifications for senior / clinical research associate
- Experience developing tools and processes that increase measured efficiencies of the project
- BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience
- Ability to use a variety of software programs (MS Office)
- Monitoring and/or site/ study management experience
- Demonstrated competence in standard business procedures (SOPs, Global Regulations)
- Experience in Oncology monitoring is preferred