Senior Clinical Research Job Description
Senior clinical research
provides guidance to the research departments, study teams, research investigators and staff to promote compliance with the research-related Code of Federal Regulations, International Conference of Harmonization (ICH) Good Clinical Practice (GCP) standards, AHRI policies and procedures, and all other applicable requirements, standards and guidelines.
Senior Clinical Research Duties & Responsibilities
To write an effective senior clinical research job description, begin by listing detailed duties, responsibilities and expectations. We have included senior clinical research job description templates that you can modify and use.
Sample responsibilities for this position include:
Clinical Research Portfolio management within designated Operating Company, , fostering strong, productive relationships with colleagues within the organization
Initiating payments to investigators
Overseeing tracking for receipt of original CRFs in house
Contribute to the development, review and revision of study management and vendor plan documents
Work directly with Investigators and site personnel to collect, track and report on feasibility information related to the identification, evaluation and selection of investigator sites
Participate in the selection and management of CRO and other third-party vendors
Manage and report on investigator site and overall study progress, including review and approval or site monitoring reports
Monitor site investigational product needs and works with clinical supplies to ensure sites receive appropriate supplies in a timely manner
Work collaboratively with Scientist and project team to ensure ongoing review of patient profiles and data listings
Participate in the review of clinical trial agreements, work orders and other site/vendor agreements
Senior Clinical Research Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Clinical Research
List any licenses or certifications required by the position: GCP, CITI, ACRP, CCRA, CCRC, CCRP, IATA, BLS, LC, SOCRA
Education for Senior Clinical Research
Typically a job would require a certain level of education.
Employers hiring for the senior clinical research job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Health, Nursing, Pharmacy, Medical, Life Sciences, Biological Science, Education, Science, Health Care, Life Science
Skills for Senior Clinical Research
Desired skills for senior clinical research 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
Medical terminology
Current GCP/ICH & country clinical research law & guidelines
EDC systems and IVRS
Desired experience for senior clinical research includes:
Attend scientific meetings and profession courses/conferences
Assist with the development, review and revision of departmental SOPs and processes
May serve as Clinical Study Project leader and/or Clinical Affairs representative on assigned project teams and/or Product Development Process (PDP) teams to provide clinical guidance, strategy, and support for the development of new technologies, new products, and extended product claims
Maintain responsibility for clinical study activities and site management for multiple clinical sites for several ongoing clinical studies
Design and develop key clinical study documents
Participate in site start-up activities including creation and shipment of the investigator site file, collection of essential regulatory documents, and IRB submission(s)
Senior Clinical Research Examples
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Senior Clinical Research Job Description
Job Description Example
Our growing company is looking to fill the role of senior clinical research. 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
- Provides assistance to the clinical trial manager in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs
- Maintain study, program, and department documents with accuracy and timeliness using Microsoft Office programs (Word, Excel and PowerPoint)
- Works closely with the Clinical Trial Assistant (CTA) to supervise Trial Master File (TMF) filing and review, and audit readiness
- Under supervision, may assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and Clinical Study Reports (CSR’S)Contributes to SOP development on an as needed basis
- Helps resolve routine study monitoring issues
- Monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents and files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required
- Participate in or conduct Pre-Investigational, Study Initiation, Site Monitoring, and Study close-Out visits at study sites
- Conduct co-monitoring and monitoring visits with contracted monitors and implement training as need to insure compliance with the protocol, CRF, SOPs and GCPs
- Plan and Implement clinical studies in all phases of drug development
- Participate in the selection and management of 3rd party vendors, which may include but not limited to contract monitors, CROs, and analytical laboratories
Qualifications for senior clinical research
- Strong knowledge, understanding and application of principles, concepts and practices of clinical investigations/studies is necessary
- Working knowledge of regulations and standards applied in clinical area and medical devices is essential
- Experience monitoring approval and surveillance studies in support of PMA and 510(k) is necessary
- Basic understanding of statistics, statistical methods, and design of experiment is preferred
- Must be an advanced user of Microsoft Office applications such as MS Word, Excel, Project, and PowerPoint
- Ability to independently set and manage multiple priorities is preferred
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Senior Clinical Research Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of senior clinical research. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior clinical research
- The clinical research associate leads or provides oversight to third party CRAs involved with site monitoring
- Participate in the study budget process and invoice tracking for 3rd party vendors, including clinical investigator sites
- Maintain communication with clinical department, investigators and clinical sites and contract clinical monitors
- Prepare all study binders prior to Study Initiation
- Prepare drug shipment requests for study drug shipments from vendors to study sites
- Verification of study drug accountability completeness at site visits
- Ensure case report forms (CRFs) are accurate, complete, and verifiable against source documents
- Verify study site screening and enrollment logs are complete and current
- Participate in collection of data relative to serious adverse events
- Ensure site compliance with the protocol, CRFs, GCP’s, resolution of data queries, and overall clinical objectives
Qualifications for senior clinical research
- Must spend his/her time and the time of others on what’s important
- Must relate well to all kinds of people, up, down, and sideways, inside and outside the organization
- Must have ability to travel domestically, at least 20% of the time
- 5+ years field clinical monitoring experience, 3+ years experience in regulated studies
- Bachelor’s degree required in health profession, life sciences or engineering field preferred
- Working knowledge of GCPs and ICH Guidelines preferred
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Senior Clinical Research Job Description
Job Description Example
Our company is looking for a senior clinical research. 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
- Provide project administrative support including maintenance of study documentation (e.g., correspondence, CRFs, study approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, ) and, as required, prepare clinical summaries
- Oversee purchase order process and invoice reconciliation for clinical studies the Clinical Affairs department, including working with accounts payable and external parties
- Monitoring of moderately complex clinical experimentation including data collection, summary and thorough analysis, in support of department research projects and guidelines
- Fully accountable for ALL aspects of site management including ensuring completion and delivery of all local activities required to ensure high quality set up, execution and completion of studies
- Communicate progress and relevant study information or escalate issues of the study to the local study management team and other key stakeholders CRA Manager
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings
- Attends clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements
- Schedules sponsor monitoring visits
- Meets with monitors / auditors during routine visits to discuss case report form completion, query resolution and other protocol-related issues
- The Senior CRA will coordinate clinical study activities including development of protocols, preparation of informed consents, investigator brochures, sections of regulatory submissions, Case Report Forms and other study materials
Qualifications for senior clinical research
- Ablility to read and interpret technical procedures and regulatory requirements
- Competent in written and oral English and Dutch
- Ethical and conscientious mentality
- Fluency in English language (written and verbal) is required Hebrew
- Bachelor’s degree in a field appropriate to the area of assignment AND four years of research administrative/coordinative program experience
- Understanding of clinical development, knowledge and experience in international (FDA, EMEA, ICH) and local regulations
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Senior Clinical Research Job Description
Job Description Example
Our growing company is looking for a senior clinical research. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior clinical research
- Coordinate and communicates with universities, contract research organizations, private practices, institutional review boards, and other functional groups engaged in the conduct of clinical studies
- Assist in developing the field monitoring organization characterized by process standardization, best practice sharing, and continuous improvement
- Assume a greater leadership role in the development and implementation of efficient and effective approaches to study site management
- Provides training, delegated by the Monitoring Manager, for new monitoring personnel and contributes to their performance appraisals, as appropriate
- Takes a leadership role within monitoring organization through assisting with clinical projects, as appropriate
- Represents US Monitoring / Global Clinical Operations on internal and external process improvement teams
- Acts as a resource for other monitoring personnel regarding study-specific knowledge, monitoring issues
- Independently complete special projects as assigned by Monitoring management
- Verify adequacy of clinical data through comparison of case report forms to source documents
- Perform CRF review, query generation and resolution against established data review guidelines
Qualifications for senior clinical research
- Bachelor’s degree in a clinical or health related field, in life sciences, or equivalent work experience
- Requires 5+ years prior experience in monitoring and managing clinical sites, ideally in oncology indications
- Works closely with Clinical Trial Manager on the preparation and conduct including monitoring of safety, efficacy and claims studies for Personal Care products
- A Bachelor's degree or equivalent in a health care or other scientific discipline
- For Senior Research Associate position, minimum 3 years clinical monitoring experience, preferably with some experience in leading clinical teams in the region
- Bachelor of Science in biology or related degree (or higher)
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Senior Clinical Research Job Description
Job Description Example
Our company is hiring for a senior clinical research. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior clinical research
- Functional expert on the CRA role and would be expected to role model and mentor junior level CRAs
- Manage at least a full complement of sites with multiple protocols depending on study/site complexity
- Maintains accurate study site information in the CTMS and records visit and non-visits contracts appropriately and in a timely manner
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
- Of clinical sites, maintenance of study files, conduct of pre-study and initiation visits
- Prove correctness of invoices from investigators against planned payments (per visit/patient) with CRA/CPA (Vendor’s staff)
- Participation in investigator meetings
- Writing and validation the technical and /or administrative documents, which are necessary for the Medical Project
- Updates CTMS (Clinical Trial Management System)
- Preparation and updating of the study risk management plan
Qualifications for senior clinical research
- Experience with Progeny database and pedigree construction a plus
- Background in genetics a plus
- Advanced degree preferred with an academic focus in natural science, nursing, bioengineering or a related academic field
- External -Internal Candidates
- 2 or more years CR expereince in pharma or CRO
- Ability to work indepentant