A Senior Clinical Research Associate handles the daily chores pertaining to the clinical investigative phase of drug development. Even though the job tasks vary depending on the employer, the common tasks mentioned on the Senior Clinical Research Associate Resume include – planning and directing clinical research trials and projects, supervising employees, providing staff training, recruiting study participants, screening trial participants through interviews and medical records reviews, monitoring ongoing research activities, designing protocols, verifying data and presenting results.
Typical skills seen on a successful resume include – experience working in a clinical research setting, proficiency with scientific software, proficiency with database software, superior deductive reasoning, and strong communication skills. Candidates should have strong interpersonal skills to gel with a team environment and deliver effective conclusions to the Research Managers. At a minimum, a Bachelor’s degree in any scientific discipline is expected for this role, however, successful resumes mention a degree in Nursing with additional certification and/or education.
Summary : Clinical Research experience including around in clinical monitoring with significant experience in infectious diseases, gastroenterology, rheumatology, oncology, orthopedics, and ophthalmology.
Skills : Clinical Trials, Fast Learner.
Description :
Performed many qualifications, initiation, monitoring, and termination visits.
Quality check visits by a sponsor, quality evaluation visits by the project lead and COL, QASVs conducted by PAREXEL's quality team.
Experienced PAREXEL's RRC audit (twice) and one sponsor audit.
Conducted on-site monitoring at Israel for one of the global studies (ophthalmology) and trained a CRA II from PAREXEL, Israel office.
Handled tough sites efficiently and was appreciated by the project team for the same.
Successful recruitment in the study, ahead of the timeline by meticulous.
Assumed the ability to meet the requirements of a CRA I and II with a high degree of proficiency and autonomy.
Experience
7-10 Years
Level
Management
Education
International Business
Senior Clinical Research Associate/Representative Resume
Summary : Extensive experience in phase I, II & III of clinical studies as well as the different types of visits including Pre-study, Initiation, Monitoring and Close-out Visits.
Skills : Microsoft Power point, Management, Medical Terminology.
Description :
Ensured that all study-related communication including e-mail is tracked, printed and filed as required.
Tracked patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities.
Ensured that all relevant documentation is current e.g., accreditation certificates, normal ranges, etc for central labs and local labs at investigator sites.
Performed site-level drug accountability, reconciliation and destruction activities.
Review site regulatory binder for completeness and up-to-date information including IRB-related documents.
Reviewed Informed Consent forms for accuracy and regulatory compliance.
Ensured proper administration of Informed Consent and advised the site of any execution issues.
Experience
7-10 Years
Level
Management
Education
Management
Jr. Senior Clinical Research Associate Resume
Objective : Experience as a Regional Clinical Research Associate 3 years of experience as a Clinical Research Coordinator Complex therapeutic experience including Neurology & Psychiatry.
Skills : Phase Forward EDC, Meidata EDC, Clinical and DataTrack.
Description :
Managed and mentored the CRA team in carrying out site management in collaboration with the project leader.
Functional group leaders for the execution of all monitoring services. Oversaw the productivity of the monitoring team.
Coordinated and supervised site monitoring assignments and activities.
Function as Lead for assigned projects and/or Project Team Meetings.
Tracked the overall study progress (progress reports) and engage in the management of subcontractors and/or vendors.
Ensured adequate filing of all study-related documents, both hard copy, as well as an electronic version, when applicable.
Developed documents (from concept to final document) independently whenever necessary as delegated by the Project Manager.
Experience
2-5 Years
Level
Junior
Education
Business Administration
Senior Clinical Research Associate/Co-ordinator Resume
Summary : Experienced in the conduct of clinical trials in roles characterized by increasing complexity. Strong concentration in oncology and phases I-III.
Maintained contact with sites and remotely monitor compliance issues on an ongoing basis.
Performed site visits from selection to close-out. Long term management of sites via interim monitoring visits.
Evaluated and ensure patient safety, data quality, and scientific integrity of clinical trials.
Maintained and verifying information across multiple clinical databases including Inform and Medidata Rave.
Query generation, resolution, and closeout. Overseeing training visits for new Quintiles employees.
Adherence to the protocol and agreed SOPs both corporate and those maintained by sponsors.
Compliance with overall study timelines to maintain recruitment progress, data cleaning, and appropriate IMP management.
Experience
7-10 Years
Level
Management
Education
BA
Senior Clinical Research Associate II Resume
Headline : Active working experience in the clinical research, with experience monitoring Oncology studies of clinical site management.
Skills : Researching Skills, Management.
Description :
Lead cross-functional technical assessment and prioritization of novel combination opportunities.
Drove prioritization process for preclinical and clinical study recommendations.
Partnered with business development to access prioritized external assets. Represent the research team in negotiations with third parties.
Lead establishment of clinical development strategy and detailed study plan with internal/external collaborators.
Lead establishment and delivery of program communication and disclosure plan.
Collaborated with Project Management to develop defined timelines, scope, and budgets for all efforts.
Collaborated with Project Management to achieve Product Team, Business Unit, and Corporate approvals as necessary.
Experience
5-7 Years
Level
Executive
Education
Clinical Gerontology
Senior Clinical Research Associate/Execuitve Resume
Headline : Seeking Senior CRA independent contract monitoring position requiring travel domestic or international. Home office in Raleigh, NC.
Skills : Communication Skills, MS-Excel.
Description :
Identify potential Laboratories to build the Laboratory Database Assist in protocol development and designing CRFs in various therapeutic areas.
Identified Vendors, negotiate services/product delivery and pricing.
Budget Negotiations with Investigators and study teams at site.
Co-ordinated trials (Ph II to IV) for different clients in various therapeutic areas like - Dermatology, Internal Medicine, Oncology, etc.
Ensured the project was run as per client expectations and timelines with minimal escalations Accomplishments.
Build a complete set of SOPs and policies for CRO services.
Build Investigator database, Laboratory database. Develop Centers of Excellence for conducting trials.
Experience
5-7 Years
Level
Executive
Education
Masters
Senior Clinical Research Associate/Analyst Resume
Objective : Experienced Director and Academic Faculty Research Management. Extensive experience in national and international program management. Skilled in the development, implementation.
Skills : Clinical Skills, Communication Skills.
Description :
Worked with other department leads to assure timely completion of project activities.
Planned and managed activities for site selection, investigator meetings, and enrollment.
Supervised, evaluated, and mentored CRAs and established goals for team members.
Developed informed consents, case report forms, monitoring guidelines, and site materials.
Attended project management meetings to ensure the maintenance of budgets and timelines.
Conducted project team meetings to review project status, project team issues, and site issues.
Compliance of studies with FDA regulations, Good Clinical Practices, and protocols Mentored new employees and taught department.
Experience
2-5 Years
Level
Junior
Education
Philosophy
Lead Senior Clinical Research Associate Resume
Summary : A highly versatile research management professional with exceptional communication skills and an extensive background in global project management, budget administration.
Skills : Communication Skills, Hard Working.
Description :
Build relationships with investigators and site staff Collect regulatory documentation.
Collaborated with CMA on-site issues/actions. Generate a visit/contact report in accordance with a monitoring plan.
Participated in Investigator and other external or internal meetings as required.
Maintained a working knowledge and ensure compliance with applicable ICH-GCP guidelines, local regulatory requirements, and study-specific procedures.
Completed routine administrative tasks in a timely manner.
Contracted work as a clinical research associate.
Site initiation visits, interim-monitor visits, close-out visits, FDA audit preparation as well as study protocol training.
Experience
7-10 Years
Level
Management
Education
Public Administration
Associate Senior Clinical Research Associate Resume
Summary : A highly experienced Senior Clinical Research Associate with considerable United States experience within the CRO and pre-clinical environment.
Skills : Researching Skills, Management.
Description :
Develops and markets innovative devices designed to treat upper airway disorders Responsible for all trial design and execution.
Created CRF's, SOP's, informed consents, protocols, and reports for all studies.
Gained 510k clearance using outside the US data for FDA indications.
Principle contact for studies from concept to completion. Manage compliance for patients, site, and post-market studies.
Directed in-house personnel on data entry and clinical filing activities.
Analyzed data and write for manuscripts, posters, and oral presentations.
Successfully transferred CRO responsibilities to in-house or site personnel.
Experience
7-10 Years
Level
Management
Education
Masters Of Science
Asst. Senior Clinical Research Associate Resume
Summary : As a Clinical Operations Leader have managed multiple studies in different phases & indications across multiple countries.
Skills : Clinical Skills, Hard Working.
Description :
Managed and monitored several multi-centered anticonvulsant drug clinical trials Conducted site-visit monitoring and maintained clinical data.
Verified contractor performance and patient safety.
Developed requests for contracts, proposals and progress reports.
Prepared and presented Clinical Trial information to NIH management.
Developed and conducted Quality assurance checks on the clinical data.
Infectious Diseases Program Coordinator/Epidemiologist Conducted surveillance of infections and investigated outbreaks.
Analyzed and presented project results to the hospital infections committee.
Experience
7-10 Years
Level
Management
Education
Statistics
Senior Clinical Research Associate Resume
Objective : Clinical Researcher with an extensive background in pediatric clinical research and the ability to lead/manage global clinical study teams. Capable of working across functional lines in a global matrix organization.
Skills : Word Perfect, Microsoft Excel, Global Electronic Library.
Description :
Managed CDA, financial disclosure, and CSA processes.
Coordinated all key communications externally (CRO, Investigator, site study staff) and internal (study team).
Responsible for managing Central Lab and investigational material.
Designed CRFs, prepared annotated CRF as required, responsible for QA of data.
Responsible for investigator budget development and negotiation.
Managed and monitored investigative sites with CRAs. converted from contract to employee.
Researched specialties included Infectious Disease- HIV, GI- Heartburn & Male Impotence.
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