As a Clinical Trial Associate (CTA) am solely responsible for the collection, review, tracking, maintenance and archiving of essential study documents in the Trial Master File (TMF), ensuring that project specific administrative
documents are maintained, and sites are supplied with all required clinical materials and supplies.
• Collects, distributes and tracks receipt of regulatory documents and other trial related documents through the life cycle of the clinical trial as needed.
• Compiles key study information from various systems into a report format for tracking and trending metrics for study team.
• Creates and maintains logs of trial related documents. Distributes and tracks reports to clinical trial sites and CRAs.
• Distributes and tracks protocol deviations. Distributes, tracks, collates and summarizes feasibility information and provides to study team as needed.
• Generates potential site information from investigator database. Maintains trackers for essential trial related documents as needed.
• Provides administrative support to study team as needed for trial related tasks.
• Ensures that clinical trial documents are filed/uploaded accurately and within expected timelines. Duties and Responsibilities
• Provide administrative support to the Clinical/Regulatory project team
• Assists the Project Manager (PM) with written and verbal communications to the study team and sites
• Reviews Clinical/Regulatory documents submitted to the Site Master File (SMF) by the study team for accuracy, completeness, and compliance with internal and Client quality standards to fulfill all federal and local regulations
• Ensure paper SMF documents are named according to standard naming conventions
• Assist the project team with reconciliation of the periodic SMF QC
• Assist in the close-out of projects by performing a final QC of the SMF, identifying items and issues for review and/or follow-up by the CRAs.
- Clinical Trial Associate at Advanced Clinical Contractor at Rexahn Pharmaceutical
- Clinical Trial Assistant at Tasly Pharmaceutical
- Clinical Trial Associate / In-House CRA at Protalex, Inc
- Clinical Trial Associate / Project Manager Assistant at AnGes, Inc
1 year at this Job
- Bachelor of Science - Business Administration / Marketing
- Associate of Arts - AA, Administrative Assistant and Secretarial Science
Therapeutic Areas: Psoriasis (Phase IV), Lumbosacral Radiculopathy (Phase II), PKU (Phase Ib)
• Develop and maintain documents, tools, forms and related items in MS Word, Excel, Access and Publisher, including reformatting and troubleshooting issues with existing documents and macros
• Assists in the development of project timelines and milestone tracking
• Provide technical assistance to project team (Project Managers, Lead CRAs, CRAs, etc.) with forms, letters, reports, manuals and other documents
• Maintain and quality audit to assure most recent revisions of documents are on portals and server
• Assist project team (CRAs, Lead CRAs and Project Managers, etc.) with collation of documentation required for submission to Regulatory Authorities and Ethics Committees administrative support to the preparation of contracts
• Regularly review the status of key documentation in the file for SOP compliance
• Interviews, trains, and develops new employees as needed
• Provide support to Clinical Operations Manager on an ad hoc basis.
• Assists Project Management staff with defining expectations and performance levels of other CTA staff members
- Senior Clinical Trial Associate at Worldwide Clinical Trials
- Up Lead at PRA Healthsciences
- Study Start-Up Specialist I/II at inVentiv Health
- Sr. Clinical Project Coordinator at Quintiles, Inc
11 months at this Job
- Master of Business Administration - Business Administration
- B.A. in Psychology - Ergonomics
Provided home care services to pharmaceutical companies with patients participating in clinical trials ranging from phases 1 - 4
• Successfully conducted multiple domestic & international oncology, immune deficiency & rare disease trials
• Reviewed protocols and lab manuals, extracting necessary information to create home health care manuals
• Managed ambulant care services involving blood draws, centrifuging and IV administration
• Attended Site Initiation Visits to train staff on study home care services and procedures
• Contracted with nursing agencies discussing Confidentially Disclosure Agreements and negotiating budget prices of required services
• Trained nurses and agency coordinators on study protocols in order to successfully perform home care visits
• Functioned as liaison between various stakeholders including Sponsors, Sites, CRO, Study vendors, & Country Coordinators to communicate home care services, provide insight, and resolve any queries
• Completed inventory and tracked study supplies
- Clinical Trial Associate at GlobalCare Clinical Trials
- Clinical Trial Assistant at GlobalCare Clinical Trials
- Rehabilitation Aide at Athletico Physical Therapy
- Psychology Department Assistant at Lake Forest College
3 months at this Job
- Bachelor of Arts - Neuroscience
Manages all aspects of the study start-up process for new trials
• Effective liaison between trial leader and central institutional review boards
• Demonstrates thorough knowledge of compliance requirements for regulatory documents
• Demonstrated success in working collaboratively on a project team
• Experienced in using the clinical trials portal and central IRB portal for posting documents; making submissions, and retrieving reports and approval documents
• Ensures that regulatory documents are received, authenticated, and archived within standard operating procedures
• Verification of Regulatory Documents in CREDI
• Communicates effectively with internal and external contacts
- Clinical Trial Associate at ReSearch Pharmaceutical Services
- Clinical Payment Analyst II - Trial Finance Operations & Logistics at NOVARTIS PHARMACEUTICALS CORPORATION
- Sr. Administrative Assistant at NOVARTIS PHARMACEUTICALS CORPORATION
- Sr. Administrative Assistant - Job Share at NOVARTIS PHARMACEUTICALS CORPORATION
7 years at this Job
- - Medical Terminology Course
As a Clinical Trial Associate I provided support to site managers throughout the star-up, maintenance, and closure of various
clinical studies. Attention to detail is imperative as I have to ensure the quality, and accuracy of regulatory information
surrounding a clinical trial meet company standards. Key Responsibilities include:
• Attend Kick-off or Investigator meetings as
• Collect Site Contact Information and Financial requested per invite from the Lead STM with Information (SCIFI) sheet business rationale provided for attendance
• Provide SciFi to Central Contracts and Grants
• Attend and participate in team and other project (CCG) and update any applicable trackers with related meetings related to the designated role date CCG issues the initial CTAg to study site in responsibilities collaboration with study team
• Manage country specific documents on
• Review, execute, and file site-selection SharePoint in collaboration with study team confidentiality agreements as required and members provide LSTM confirmation of executed
• Manage regional STM/SMM assignments in agreements Eclipse (In-House Studies) Blinded and
• In collaboration with STM, send Site Feasibility Unblinded Survey link with protocol synopsis to study sites
• Manage Eclipse set-up at the US country and site after CDA is received level to include site creation, entry of IP address,
• Maintain MyTrials at the US Country level entry of Study Connect contact, SMN Manager within Study Tools; enable appropriate alerts at Assignment, STM Assignment, IRB Chairperson time of site enablement, upload country specific entry, scoping of IRB approvals, and entry of documents to study tools applicable country M&D's in collaboration with
• Ensure US Sites are alerted of country specific STM Protocol Amendments/ICFS/Administrative Letters available on My Trials, as required
- Clinical Trial Associate at Bristol-Myers Squibb
- Start-Up Specialist Intern at DrugDev
3 months at this Job
- Master of Science in Health Informatic - Health Informatic
- Bachelor of Arts in Psychology - Psychology
* Reviewed regulatory documents such as CVs, 1572s, and Financial Disclosure Forms for site activation. * Reviewed, negotiated and approved site-specific and study-specific ICF language. * Assisted with conversion of Trial Master File to electronic Trial Master File.
- Clinical Trial Associate at ReSearch Pharmaceutical Services
- Clinical Project Assistant at sanofi-aventis
- Study Start-up Assistant at Kendle International, Inc
- Project Assistant at
4 months at this Job
- Bachelor of Science - Biochemistry
- - Chemistry
- MBA - Pharmaceutical Management
• Provides continuous support to CRAs and Clinical Team Leaders (CTL) with the day-to-da) administrations of assigned clinical studies.
• Prepares and distributes Investigator Site Files (ISFs). Pharmacy Site Files (PSFs) or other files needed for Site Initiation Visits (SIVs).
• Assists CRA with adaptation of study specific forms for Investigator Site Files.
• Prepares and maintains Trial Master File (CMF and IFs) according to Pharm- Olam SOPs or Sponsor SOP, as required.
• Reviews study files periodically for accuracy and completeness.
• Prepares and maintains QC/Inventory Checklists for the TMF (CMF and IFs) and JSFs.
• Assists CRA in the QC ofTMF (CMF and IFs).
• Maintains Public Folders/ePOI/S drive in accordance with the Filing Plan.
• Assists CRAs with collection and tracking of critical documents.
• Prepares and maintains country and sites related study trackers, as needed.
• Assists CRAs with preparation of the Essential Document Packages (EDP), collection of related documents from the sites and obtaining EDP approval.
• Performs translations and back-translations of study documentation when needed.
• Performs administrative task support (such as collection of required documents) to CRA or Local Regulatory Officer in submission process, as required.
• Performs any other administrative tasks that may be required to support submission process in the country.
• Obtains quotes from local vendors (printing companies, translators, couriers) and provides information to the CRA/CTL for obtaining approval from PM/CTL prior to placing orders.
• Prepares and distributes clinical trial supplies to the investigational sites and maintains tracking documentation.
• Assists CRA in obtaining signatures and tracking of site contracts, if required.
• Attends study teleconferences and prepares minutes in accordance with study requirements to support Project CTA, if needed.
• If needed, provides local support for organization of Investigator Meeting or any other study meeting organized in the country where CTA is located and coordinates with the hotel staff to ensure smooth running of the meeting.
• Accurately updates and maintains CTMS or other clinical systems within project timelines.
• Generates and reviews reports from internal tracking systems at requested intervals to follow-up on pending entries.
• As needed, communicates with sites regarding trial start-up, conduct, and close- out administrative and logistical activities.
• At the study end prepares TMF (CMF and IF) for sending to Sponsor and follows up with the recipient for Confirmation of Receipt.
• Resolves local logistical and practical study related issues.
• Performs any other administrative tasks not listed above to support team members with clinical trial execution, as required.
• Provides training and mentoring to new CTAs on Pharm-Olam procedures and clinical trial administration, as required.
• If needed, attends non-study related and executive teleconferences and prepares and distributes minutes for meeting attendees within agreed timelines.
• May participate in feasibility and/or site identification activities.
- Clinical Trial Associate III at Pharm-Olam International
- Administrative Research Assistant at DM Clinical Research
- Fleet Supervisor at Expedited Logistics and Freight Services
2 years at this Job
- License - Cosmetology Operators
- High School Diploma
DECEMBER TO PRESENT
• Support the activities of the Principal Investigator
• Conduct off site audits
• Initiates and develop process improvements RESEARCH ASSISTANT II (FULL TIME) VANDERBILT UNIVERSITY AUGUST 2013 TO PRESENT
• Coach Trial and Grow Trial Interventionist - Deliver Intervention for GROW and COACH Trial's participants in Community Centers, perform T7 Feedback Reports, contribute with GROW Web page.
• Give Intervention Sessions over the phone, schedule data collection
• Help interventionist in Sessions (Greeting, record keeping, breakdown classroom)
• Assist in Data Collection (Greeting participants and conduct surveys)
• Enter Data Collection and Intervention Data in red Cap
• COACH-Screened, schedule for data collection, deliver Intervention sessions face to face and over the phone.
• Library Sessions trainee
• Organize and deliver Focus Group
- CLINICAL TRIAL ASSOCIATE II at VANDERBILT UNIVERSITY
- Podiatrist Association of Puerto Rico at THE EINSTEIN GROUP
- RESEARCH ASSISTANT II (FLEX STAFF) at VANDERBILT UNIVERSITY
- Promotions Development and Programming Director at ON AIR PESRSONALITY REVOLU MORNING SHOW
5 years, 7 months at this Job
- Bachelor Degree in Science of Communications - Science Communications
• Support the clinical study teams in the execution and delivery of clinical trials through planning, preparation, and on-site support of investigators
• Prepare, collect, and maintain internal and external documentation required for clinical trials, including FDA Form 1572, CVs, Informed Consent Forms, and Financial Disclosures, etc.; Ensure documentation is completed in accordance with ICH and GCP regulatory requirements and is consistent with the study protocol
• Provide information for, reconcile, and process investigator payments for subject visits and pass-through expenses according to contractual budgets and schedules; Continuous communication with study sites, industry sponsors, and supporting vendors
• Maintain screening & enrollment tracking database to assist management with subject recruitment strategies and projections
• Create metrics, KPI tracking spreadsheets and reports for management review
• Prepare and distribute meeting agendas and minutes; actively participate in team meetings
- Clinical Trial Associate at Palm Beach CRO
- Intern at Courtyard Gardens Rehabilitation Center
- Student Assistant at Florida Atlantic University
- Administrative Support/Nurse Assistant at Florida Atlantic University
3 years, 1 month at this Job
- MBA - Complex Health Systems
- Bachelor of Health Services
• Support the clinical trial management study team in project operations
• Ensures all study related regulatory documents are collected and reviewed in support of study activation
• Organizes and maintains project working files and tracks critical documents
• Generates reports to assist the Clinical Research Associates to perform monitoring visits
• Works with team members in the creation and maintenance of the TMF
• Assists with the preparation and distribution of meeting agendas and minutes
• Supports and corresponds with sites to identify site specific needs
- Clinical Trial Associate at Criterium Inc
- Production Operator at Global Foundries
- Sales Associate at 51vape
- Cocktail Waitress at Saratoga Casino
3 months at this Job
- High school or equivalent