A Clinical Research Consultant manages clinical trials and studies relating to biotechnological and pharmaceutical products, drugs, and procedures. The job description includes researching to ensure the products are safe to be released and used in the market. While the duties tend to vary based on the type of research being conducted, the following are certain core duties mentioned on the Clinical Research Consultant Resume – creating, and writing trail protocols; identifying and establishing trial sites, training site staff on therapeutic areas, ordering and managing IP and trial materials; conducting regular site visits, liaising with regulatory authorities; and ensuring compliance with SOPs and local regulations, and GCP and ICH guidelines.
Employers tend to pick resumes denoting the following skills – knowledge of the pharmaceutical industry, terminology, and practices; a deep understanding of FDA regulations and their practical implementation; strong verbal and written communication skills, and proficiency with MS Office and Excel. To become one, it is necessary to hold an undergraduate or postgraduate qualification in life science, nursing, or microbiology.
Headline : Clinical Research Consultant is responsible for Managing clinical research projects as they are initiated or completed at the clinical site, Planning and executing prospective research initiatives at the clinical site, Leading team in recruitment of investigators for projects that require intensive training or experience.
Skills : EDC, Microsoft Office, Auditing Software.
Description :
Trained the students about clinical research.
Trained was also provided for the newly appointed trainers.
Included the importance of auditing & Inspections in clinical trials.
Regulatory affair-ed and guidelines Various aspects of IND and NDA submissions and regulatory requirements for the trials.
Promoted the Institution by giving presentations in various Colleges.
Reported to project team and site personnel any findings noted at monitoring visits.
Sourced verified subject data in the electronic CRF database.
Experience
5-7 Years
Level
Executive
Education
M.Sc In Clinical Research
Clinical Research Consultant Resume
Headline : Clinical Research Consultant with a military background, extensive experience in leadership, driving results, directing administrative and operational matters in private, non-profit, military, and government health care agencies. Innovative problem-solver with a proven record of accomplishment of generating revenue and company growth. Goal-oriented leader entrusted with complex issues and an ability to work independently or as a team player.
Skills : Clinical research, Medical and scientific writing,.
Description :
Partnered with sites to ensure recruitment goals are met.
Assisted sites with operational needs (e.g. vendor activities, site payment).
Submitted monitoring visit reports (MVRs) for all monitoring visits conducted.
Sent follow-up letter to Principal Investigator summarising visit conduct and all action items.
Contacted the Regional Operations Manager (ROM) regarding significant site conduct issues.
Met all departmental timelines and deliverables for review/queries of all electronic case report forms.
Managed assigned sites by regular contacts to ensure site compliance, adequate enrolment, and understanding of study requirements.
Experience
5-7 Years
Level
Executive
Education
MHA In Health Care
Clinical Research Consultant Resume
Headline : Extensive experience in the life cycle of the clinical research process including the initiation of study startup activities, ongoing monitoring and close-out of clinical investigative sites. o Excellent interpersonal and business development skills with experience in the recruitment of investigator sites, the collection and verification of investigator documentation, conduct pre-site qualification visits and the negotiation of Clinical Trial Agreements and site budgets.
Skills : Consulting, Clinical Skills, Training.
Description :
Responsible for establishing minimum learning standards/requirements for the Emory University research community including the development of Continuing Educational Courses as related to clinical research quality assurance, Good Clinical Practice standards, source documentation, contract and budget negotiations and research billing compliance.
Served as the central resource for the research community at Emory to provide expertise and guidance on complex issues, related to clinical research study start-up, billing compliance, budget negotiation and contract execution.
Developed and facilitated live and online courses for Emory Research Investigators, Coordinators and Administrators.
Utilised essential training software such as Adobe Captivate, Net Learning, Black Board and People Soft.
Assisted in the development of clinical research billing compliance SOPs.
Provided support and mentoring to research staff as needed.
Provided clinical trial consulting to pharmaceutical and biotechnology companies as requested with an emphasis on monitoring and site management.
Experience
5-7 Years
Level
Executive
Education
MS
Clinical Research Consultant Resume
Objective : Clinical Research Consultant is responsible for Facilitating and tracking corrective action plans, in support of management, to foster completion and achieve compliance, Thoroughly reviewing complex study protocols and Informed Consent Documents (ICDs) to identify all Emory Healthcare (EHC) and/or Grady billable items and services required of the study which might generate a CPT code that requires a Prospective Reimbursement Analysis (PRA) to ensure research billing compliance.
Skills : Drug Safety, Researching, Clinical Skills.
Description :
Assisted with the optimal application of Federal, State, and local laws, guidance documents, Emory University Institutional policies, and Institutional Review Board (IRB) policies and procedures while meeting the objectives of the Emory University research community.
Consulted on complex research and regulatory issues in conjunction with the team(s) to identify solutions and develop improvement processes.
Researched topics of departmental, institutional or strategic importance.
Served as the central resource for the research community to provide expertise and guidance on complex issues, operational goals, business strategies, ethical considerations, regulatory mandates, and institutional policies related to human research protections.
Developed and facilitated training programs to accomplish goals.
Planned and conducted independent audits to assess compliance with regulations, guidelines, institutional policies, and operating procedures for the purpose of preventing and detecting inaccuracies and mismanagement, while promoting accountability and efficiency within OCR teams.
Prepared and distributed report of findings to the Executive Director and appropriate members of the Leadership Team.
Experience
2-5 Years
Level
Junior
Education
Bachelor Of Science In Biology
Clinical Research Consultant Resume
Summary : Clinical Research Consultant with more than nine years of experience initiating, monitoring, and closing out clinical trials for major pharmaceutical companies. Possesses thorough understanding of FDA regulations, GCP and ICH guidelines, and standard clinical trial protocol and technical aspects of pharmaceutical research.
Skills : Clinical Research, Interpersonal Skills.
Description :
Managed clinical sites as a monitor for a Phase III cardiovascular study from site evaluation through site initiation and closeout.
Identified and evaluated potential study sites.
Conducted pre-trial, initiation, routine and close-out visits.
Source verified subject data in the electronic CRF database.
Audited regulatory documents.
Provided ongoing communication and follow up with clinical sites.
Observed study conduct.
Experience
10+ Years
Level
Senior
Education
B.S. In Biology
Clinical Research Consultant Resume
Objective : Critical thinker seamlessly acclimating to changing fiscal, regulatory and clinical environments. Future-oriented, self-directed consistently functioning at a high level of performance particularly in the gray areas of healthcare. Knowledgeable educator with the ability to translate complexity into mainstream comprehensibility.
Skills : Planning, Auditing, Clinical Skills, Medical Service.
Description :
Managed clinical sites as a monitor for medical device (contact lens) studies from site initiation through site closure.
Conducted interim and site closure visits.
Sourced verifies subject data in the electronic CRF database.
Audited regulatory documents.
Provides ongoing communication and follow up with clinical sites.
Managed clinical sites as a monitor for a Phase IV PKU study from site initiation through closeout.
Conducted initiation, routine and close-out visits.
Experience
2-5 Years
Level
Junior
Education
Bachelor Of Science In Biology
Clinical Research Consultant Resume
Objective : Clinical Research Consultant with 5 years of experience in Building relationships with the Clinical Research Institute (CRI) on behalf of your company through comprehensive marketing efforts, Ensuring compliance with regulatory requirements by monitoring activities closely throughout project life cycle; identifying potential issues early in project development; recommend corrective actions to address these issues from an ethical standpoint.
Skills : Planning, Supportive Skills, Marketing.
Description :
Developed market intelligence through onsite visits to major research sites, as well as via webinars and other forms of communication with key stakeholders.
Worked closely with the business operations team during project development and execution; work closely with the Clinical Research Manager on projects that require a higher level of management attention.
Collaborated with internal and external researchers to develop appropriate protocols for both preclinical studies (Phase I & II) as well as Phase.
Developed a plan for recruiting and retaining participants.
Analyzed the raw data collected to determine participant eligibility and risk factors.
Developed a statistical analysis to help determine risks and benefits of participants in the trial.
Reviewed data from all phases of the clinical trial.
Experience
2-5 Years
Level
Executive
Education
GED
Clinical Research Consultant Resume
Summary : Clinical Research Consultant with 9 years of experience in Planning and executing clinical trials in a timely manner, Understanding and prioritising the research projects for each clinical trial, Interacting with key stakeholders to manage the projects through the entire process, Following up with project milestones as well as deliverables at regular intervals.
Skills : Planning, Stakeholder, MS Office.
Description :
Conducted ongoing post-trial analysis of patient outcomes.
Provided ongoing support to clinical staff throughout the study.
Developed technical documentation for clinical research projects.
Provided technical support to clinical investigators on completing all required information for all phases of a project.
Assisted in the preparation of an IRB application for a study with at least three Phase I studies or Phase II studies.
Assisted in preparation of an IRB application for a study with at least three Phase III studies or Phase IV studies.
Assisted in the preparation of an IRB application for a study with at least four Phase I trials or Phase II trials.
Experience
7-10 Years
Level
Management
Education
MS
Clinical Research Consultant Resume
Headline : To obtain a Clinical Research Consultant, responsible for participating in all aspects of the project including: risk analysis, grant writing, budgeting, review of data and final submission to regulatory agencies, Acting as a leader within the organization, Developing an understanding of medical device regulations and regulatory approval processes, Designing a protocol according to FDA guidelines, Performing pre-licensure studies, Performing regulatory studies, Performing post approval testing.
Assisted in preparing an IRB application for a study with at least four Phase III trials or Phase IV trials.
Collaborated with internal and external vendors to obtain necessary supplies.
Collected data from subjects.
Created and analyzed data from the analysis phase of the study.
Presented results at industry conferences and meeting with regulatory agencies.
Provided technical assistance to investigators and clinical investigators.
Communicated with regulators regarding study requests and results of studies.
Experience
5-7 Years
Level
Executive
Education
G.E.D
Clinical Research Consultant Resume
Headline : Clinical Research Consultant is responsible for Conducting pre-clinical and clinical research for new drug discovery, development, and manufacturing, Developing and executing clinical trials as needed to support product development efforts, Assisting with the design of appropriate study protocols, including dose selection, target identification, sample collection, patient recruitment, and data analysis.
Skills : Data Analyst, Developing, Planning.
Description :
Managed financial resources for study performance, including budgeting, contract negotiation, insurance reimbursement, and sponsorship issues.
Developed research protocols to meet regulatory requirements.
Conducted interviews with patients and their families to determine the goals of a clinical trial.
Planned and developed the required documentation for a clinical trial.
Reviewed all testing protocols, questionnaires and other documentation from the study team prior to launch of a trial.
Monitored study results to ensure compliance with regulations.
Facilitated the review of manuscript submissions by authors for publication in peer reviewed journals.
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