Oversight Clinical Research Associate, responsible for the supervision and administration of clinical trial protocols for various CROs under the guidance of the sponsor of the clinical trial. Duties include assisting with the design and implementation of clinical research projects and oversee activities of investigational sites to ensure compliance with protocol and overall clinical objectives.
Therapeutic Area/Lab Experience
• Phase III Dermatology Trial (Pruritus in Hemodialysis) Key Areas of Responsibility:
• Maintain expertise with current GCPs (domestic and international).
• Participate in development of case report forms, study start-up documents, and study tracking tools.
• Negotiate investigational site budgets, site payments, and assist with CRO management and payment.
• Track subject enrollment and collect safety information for interim analyses.
• Act as company representative and provide guidance to other personnel.
• Update all clinical trials tracking tools for Trial Master File (TMF), such as monitoring visits, enrollment, laboratory samples, data cleaning, other vendor tracking and training.
• Manage study-related vendors and serve as the primary point of contact for contracted CROs, study staff, and contract labs.
• Review monitoring reports, protocol deviations, and data listings for sponsored studies.
• Collaborate with CROs on site selection, IRB submissions, site initiation, and closeout planning.
• Oversee clinical trial master files to ensure their compliance with required regulatory and ICH/GCP quality standards and consistency with SOPs.
• Ensure all adverse events or product safety issues are captured, reported, and evaluated by appropriate Clinical personnel in a timely manner.
- Oversight Clinical Research Associate at Advanced Clinical
- Senior Clinical Research Associate at Chiltern International
- Dialysis Registered Nurse at Thomas Jefferson University Hospital
- Clinical Research Associate II at URL Pharma Inc
4 months at this Job
- Associates in Nursing - Nursing
- Bachelor of Science
• Monitor all aspects of clinical trials Phase I - IV to ensure trials adhere to Federal Regulations, Good Clinical Practices and ICH Guidelines. Conduct Pre-Study Visits to determine qualifications of PI and Site Staff.
• Regularly interact with physicians, pharmacy, management and clinical scientists as a key participant implementing the client's clinical efforts.
• Generate study source and start-up documents, SIV presentations and tracking tools to confirm trial records are accurate and complete therefore enabling the clinical study to begin.
• Conduct Site Initiation Visits to instruct all research staff on protocol adherence, ICF administration, Investigational Product, IRB requirements, adherence to Good Clinical Practices and FDA Regulations
• Conduct Interim Monitoring Visits to evaluate protocol adherence, GCP compliance, review patient safety and complete all monitoring oversight functions as outlined in the Clinical Monitoring Plan.
• Conduct Closeout Visits to perform a final reconciliation of all study related documents, Investigational Product, finalize all previous outstanding items and discuss ongoing investigator responsibilities.
• Lead Clinical Research Associate (6 years total over several projects)
• Typically work on 1-2 Protocols with different Sponsors simultaneously Role Years of trial Participation Sponsor Company
- Senior Contract Clinical Research Associate at Life Science Clinical Research LLC
- Senior Clinical Research Associate at Syndax Pharmaceuticals
- Senior Clinical Research Associate at Genfit Pharmaceutical
- Senior Clinical Research Associate at Sage Therapeutics
21 years at this Job
Clinical Research Associate II Clinical Research Associate I Senior Intern · Perform routine monitoring visits at research sites in compliance with the approved protocol · Complete monitoring reports and follow-up letters, which includes providing summaries of significant findings, protocol deviations, and recommended actions to secure site compliance · Verify medical records and research source documentation against case report form data · Demonstrate teamwork and leadership skills by ensuring timelines for set projects are met
- Clinical Research Associate II at Medpace
- Receptionist/ Front Office Staff at Greater Cincinnati Internal Medicine
- Mason Branch Fitness Center Intern at Tri-Health
2 years, 11 months at this Job
- Bachelors of Health Science - Exercise Physiology
• Conducts site monitoring responsibilities for clinical trials according to company SOPs, ICH guidelines and GCP, including Pre-Study, Site Initiation, Routine Monitoring, and Close-Out Visits.
• Ensures the safety of Clinical Trial subjects and the credibility of data collected by sites
• Verifies SAE reporting according to trial specifications and ICH GCP guidelines.
• Performs source document verification and query resolution.
• Maintains timelines. Ensures accuracy and completeness of data entered into company system.
• Builds strong, long term-relationships with the investigators, study coordinators, and other research personnel based on respect, knowledge, and commitment to appropriate clinical research parties.
• Reviews Trip reports of entry Level Clinical Research Associate.
• Updates applicable tracking systems.
• Assist with coordinating all the necessary activities required to set up and monitor a study including; identify investigators, help when requested in preparation of regulatory submissions, design patient information sheets and consent forms, coordinate documents transition, verification, and back translations where required.
• Develops and submits accurate trip reports according to Sponsor and CRO requirements
• Assesses IP accountability, dispensation, and compliance at the investigative sites.
• Assures study related clinical activities are conducted in compliance with GCP/ICH guidelines, SOPs, and project requirements.
• Tracks CRF status and ensures timely completion CRFs.
• Maintains the site trial master file.
• Ensures that all required study documents and materials in support of study execution are complete, accurate, and are maintained and updated as required.
• Provides timely response to protocol/study related questions received from sites and or Clinical Team Leaders.
• Attend and participate in Investigator's Meeting
• Monitored and tracked patient enrollment and study progress.
• Ensure proper reconciliation of the Regulatory Binder with the Trial Master File via frequent TMF submissions.
• Ensure timely resolution of EDC queries and site issues according to PRA SOP and Sponsor SOP.
- Clinical Research Associate at PRA Health Science
- Clinical Research Coordinator at Emory University teaching Hospital
7 years, 5 months at this Job
- Bachelor of Science in Public Health - Public Health/ Healthcare Administration
- Masters in Business Administration - health care management
Currently working as a Clinical Research Associate co-managing a Phase IIB and III IND Multi-Center study; managing smaller investigator initiated studies; regulatory document; assist with protocol and CRF design and development; write Company SOP and ensuring the planning, and coordinating of clinical research projects in accordance with ICH guideline/Federal regulations, and working with key holders to meet overall clinical objective.
• Performing site evaluation, site initiation, and Site close out visits
• Performing IRB/IE submissions, and ensuring that Investigator Site Files (ISF) are accurate, current and identical to Trial Master File (TMF)
• Assisting in the development of case report forms, informed consent forms and IRB materials
• Acting as the point of contact to site for critical issues at site requiring sponsor inputs
• Preparing, tracking, and shipping site study supplies
• Ensuring sponsor and investigator meet obligations and are compliant with applicable regulatory requirements and ICH guidelines
• Conducting monitoring visits for protocol compliance, adherence to good clinical practice, personnel qualification assessments drug accountability, and implementing follow-up or corrective action as needed.
• Requesting any new or updated site-related essential and non-essential documents and reviewing them for content, consistency with other document and compliance with appropriate regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.
• Performing source document verification, retrieving case reports forms (CRFs) and performing query resolution in a timely manner.
• Providing timely reporting of subject safety, product quality complaints, adverse events (AEs), serious adverse events (SAEs) and protocol violations to sponsor and IRB
• Writing monitor visit reports and follow-up letters, and communicating findings with the appropriate staff and investigators
• Attending study-related investigator meetings and departmental meetings
• Evaluating clinical data/information, providing interim and final clinical study reports
- Clinical Research Associate at MiMedx Group INC
- Clinical Research Coordinator at Morristown Memorial Hospital
- Research scientist at Drew University Science Department
2 years, 3 months at this Job
- MPH - Public Health
- BA - Biology
Clinical Development Manager responsibilities -Oversee study start up activities including but not limited to Clinical Operations representative for Protocol development, EDC database development in conjunction with Data management, drive site selection, develop and implement Monitoring Plan, finalize paper CRFs for Investigator and Case binders, liaison with the legal department concerning Owner Informed Consents, Clinical Trial Agreements, and case recruitment literature, and manage study binder organization. In life/study completion activities include but are not limited to managing CRAs to ensure timely monitoring of cases and adherence to Protocol and VICH GCP guidelines, ensure completeness of TMF, review and approve monitoring reports, draft Amendments as necessary, inform shareholders of study metrics, regularly review export of data listings for quality review and to identify potential AE's and or deviations that may affect case evaluability, drive study team to meet requested study timelines, and ensure adherence to regulatory requirements. Lead Monitor responsibilities - Develop site initiation training presentation, draft paper CRFs for Investigator and Case binders, create Chain of Custody forms for site documents and cases, create study tools including recruitment tracker, IVP tracker, site contact list, Study FAQs, and medical review tracker, draft recruitment tools including owner brochure, rDVM letters, and study website, perform UAT testing for EDC database development and as needed change controls, lead study team meetings with the CRAs, Clinical Development Manager, and Data Management, and provide meeting minutes. Sr. Clinical Research Associate responsibilities- Monitor clinical and laboratory studies and ensure compliance with internal and external guidelines (SOP's, GxP's, VICH, CFRs including part 11) as well as applicable regulations. Performs all tasks required for onsite/remote monitoring including but not limited to source document review and source document verification. Completes and submits monitoring visit reports in accordance with the Monitoring Plan. Co-ordinate data management processes including data entry, review, tracking and verification. Serve as the principle communication link between the Sponsor and study site. Planning and conducting study team meetings.
- Sr. Clinical Research Associate at KindredBio
- Senior Veterinary Clinical Research Associate-Senior Associate II at Zoetis
- CRO CRAs to ensure expectations and core at Elanco Animal Health
- at Novartis Animal Health
1 year, 8 months at this Job
- M.S. - Clinical Research Organization and Management
- B.A. - Psychology
Trained clinical research associates for ICH GCP, Quality monitoring, regulatory training, audits and inspections, Writing Professional Monitoring reports and Follow Up
Letters. Subject recruitment retention and compliance and Misconduct and fraud in clinical research.
• Was Involved in the Competency Testing and evaluation of the CRA's trained by the company and reporting the site compliance to the Senior Manager according to ICH- GCP and cGMP guidelines.
• Responsible for the successful management of team and clinical data, while working in accordance with ICH-GCP guidelines, site SOPs and applicable regulatory requirements.
• Fostered effective relationships with site staff to ensure that key clinical metrics were met. This involved establishing innovative ways of increasing team productivity while writing the SOP's. When issues occurred within the team; proactively and promptly implemented corrective action plans and delivered appropriate trainings.
• Developed strong working relationships and maintained effective communication within the Clinical Operations Group, as well as other functional departments within the company.
- Remote Clinical Research Associate at Axilogy Consultants, Clinical Research Team
- Operations Manager at Xenon Health
- Operations Senior Business Data Analyst at Emmyco
- Clinical Trials Analyst at Flatiron Health, Clinical Data Team
1 year, 4 months at this Job
- Bachelor of Science - Bio and Chemical Engineering
• Oversees the progress of a Clinical Trial
• Ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements.
• Administer protocol and related study training to assigned site.
• Establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
- Senior Clinical Research Associate at Sonar Clinical Research
- Clinical Research Associate II; Worldwide Clinical Trials at WCT
- Clinical Research I & II at Contract
2 years, 4 months at this Job
- Masters of Business - Healthcare Services
- Bachelor's - Criminal Justice
CRA III, Strategic Resourcing
• Perform routine site visits, including Pre-Study, Initiation, Routine, and Closeout visits.
• Visits to include monitoring of proper informed consent procedures, source document verification, and compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements, and in accordance with the monitoring plan. Assurance of good site performance.
• Central point of communication between Sponsor and Investigators for all clinical trial related activities to assure deliverables are met and activities are fully GCP, ICH and SOP compliant.
• Review and Approval of Initiation, Routine and Close-Out Visit reports including tracking of PI meeting, Regulatory and Pharmacy review.
• Conduct Site and Primary Investigator Screening Visits to assess eligibility for participation in Novartis clinical trials.
• Mentoring of new hires including coordinating site and home office visits with current Field Monitors. Solicit and record feedback on progress during onboarding period and liaise with Training Coordinator and CRA Manager to identify areas of competency and provide ancillary training support where needed.
• Track progress on Trial Site Closures post Final Database Lock. Run reports to identify open sites and follow-up with FMs to request greenlight and schedule Close-Out Visits. Provide feedback to Study Lead CRA Manager on an ongoing basis.
- Clinical Research Associate III at Syneos Health (formerly INC Research/inVentiv Health Clinical)
- Associate Project Manager, Oncology, Early Clinical Development at Covance - Clinical Development Services
- Clinical Research Associate at Novartis Clinical Operations - Oncology
- Trial Project Administrator at Novartis Clinical Operations - Oncology
2 years, 8 months at this Job
Perform routine and moderately complex on-site and in-house site assessments independently for clinical trials research.
• Collect, document, update, and report study information according to procedures and timelines.
• Create new and customize existing templates and processes to meet project needs with some direction.
• Follow up, resolve, and report on issues identified during study monitoring and assessment activities with minimal to no direction.
• Therapeutic Area Experience in Clinical Trials include: cardiovascular studies in adults and pediatric infectious disease.
- CLINICAL RESEARCH ASSOCIATE at DUKE CLINICAL RESEARCH INSTITUTE
- AGENT REPRESENTING ROCHE DIAGNOSTICS CLINICAL OPERATIONS at DOCS GLOBAL
- MEDICAL LABORATORY TECHNOLOGIST at NORTH CAROLINA STATE LAB OF PUBLIC HEALTH
- ONCOLOGY TECHNOLOGIST at LABCORP, INC
1 year, 7 months at this Job
- MASTERS OF HEALTH ADMINISTRATION - Science Leadership
- Bachelors of Science in BIOLOGY - BIOLOGY