Edwin F. Archbold, Phd, Ma Email & Phone Number

Perform and coordinate all aspects of the clinical monitoring and site management process as clinical research consultant. Help design and implement source documents. Consult and use various Electronic Medical Records and Electronic Data Capture platforms. Consult for monitoring rescue, project management and quality assurance in the field.

Raleigh, Nc, Us

Primary liaison for project site personnel throughout the study lifecycle from site identification through close out, including site identification and site start-up support.Performed site evaluation, site initiation, interim monitoring, and close-out assessments on-site or remotely, telephone assessments and central monitoring remotely, and site management, ensuring regulatory, ICH-GCP, and protocol compliance.Used judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicated/escalated serious issues to the project team and developed action plans. Immediately escalates serious issues to the project team and develops action plans.Reconciled contents of the ISF with Trial Maste File (TMF) and keeps TMF inspection ready.Provided training and completed sign-off visits for junior CRA staff.In accordance with the CMP, assessed site processes and facilities, conducted Source Document Review and Source Document Verification, applied query resolution techniques remotely and on site, performed investigational product accountability, and reviewed the Investigator Site File and reconciled the Trial Master File.Assessed factors that might affect patient safety and clinical data integrity at a site such as protocol deviations and pharmacovigilance issues.Documented activities via confirmation letters, follow-up letters, site assessment reports, communication logs, and other required project documents as per SOPs and the CMP.Routinely reviewed clinical systems, dashboards, and documentation to oversee site conduct and identify any risks to delivery or quality.Reviewed study and site data listings and visualizations via analytical dashboards and/or reports to identify trends, risks, suspected scientific misconduct on other systematic errors that could impact data integrity and subject safety.

Research Triangle Park, Nc, Us

Performed feasibility studies for potential sites as requested.Conducted pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements.Functioned in the role of Lead CRA for global studies, coordinating CRAs.Conducted site visit trip report review and provided feedback and edits.Provided mentoring and guidance to less experienced CRAs and site staff when needed.Actively participated in study team and investigator meetings.Created and conducted training to study team members or colleagues as requested and appropriate.Worked with Project Management to evaluate deliverables and study milestones.Compiled and ensured completeness of regulatory documents and ethical submission documentation as appropriate and required IRB / IEC study approval, and informed consent.Provided input into the design of protocols and CRFs as requested.Assessed, monitored, and trained study site staff on protocol adherence as required.Conducted source document verification for compliance, patient safety, and veracity of data.Reviewed CRFs using paper or electronic data capture systems and assist sites with data query resolution.Provided applicable updates for site related documentation for filing in the Trial Master File (TMF).Ensured site compliance with IP receipt, accountability and return or destruction.Conducted accompanied site visits for assessment or training of other CRAs as required.

Toronto, Ontario, Ca

Interacted with personnel from study sponsors, investigational sites, vendors, and Everest functional groups to enable timely and high-quality initiations and completions of clinical trials. Compiled documentation for qualification of clinical sites. Review that documentation to ensure that those clinical sites comply with ICH-GCP and relevant local regulations.Assist with the preparation and submission of regulatory documents to responsible authorities and IRBs and ethical committees.Established, maintained, and archived files of essential document from investigative sites and for inclusion in Trial Master Files (TMFs). The files were maintained to be continuously available for audit and completion for archive.Contributed to the development of documents that facilitate or describe the management of the clinical trial. Examples of such documents include Monitoring Plans, Risk Management, study guides or manuals, and information collection tools.Developed and reviewed documentation of information provided to study subjects, including informed consent forms.Participated in and prepare presentations for clinical trial initiation meetings such as investigator meetings or site monitor/coordinator training sessions. Address questions/concerns relevant to Clinical Operations from the meeting participants.Documented monitoring activities through submission of monitoring reports to Clinical Operations management for review, and through correspondence and telephone contact with investigative sites.Communicate directly with sites to provide direction, to assess performance, and to propose interventions to enhance enrollment performance.Participated in the development and maintenance of, and adhered to departmental Standard Operating Procedures (SOPs) and guidelines.Prepared, maintained, and completed training on study-specific and/or applicable sponsor SOPs.Supported sites in their efforts to prepare for audits conducted either by sponsors or regulatory authorities.

Assisted with overall execution of regulated and clinical projects or non-regulated clinical projects including study planning, initiation, budget tracking, tracking and supporting subject recruitment, and site support.Interfaced and collaborated with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel.Ensured personal and company compliance with Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance.Managed activities of assigned clinical studies within the Clinical R&D Operations group.Ensured that study centers complied with Good Clinical Practices and ICH Guidelines.Quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical projects.

Performed and coordinated all aspects of the clinical monitoring and site management process as clinical research consultant. Helped design source documents. Consulted on Electronic Medical Record systems. Consulted for monitoring, project management and QA.

Raleigh, North Carolina, Us

Completed project activities associated with monitoring functions of Phase I-IV clinical research studies while demonstrating mastery and a deep understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations.Provided clinical and technical support for Clinical Research Associates (CRA) I, II, and III and administrative staff.Performed management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.Helped provide direction and guidance to project team, coordinating all monitoring activities, and communicating the status of these activities to the study Project Leader. Maintained timely and effective communication among team members and site staff.

Fort Washington, Pa, Us

Served as Senior Site Manager monitoring clinical trials in pharmaceutical and biotech industry. Monitored all aspects of site start-up and development including site evaluation, site initiation, monitoring and closeout as required. Worked on CTMS and Medidata CTMS plarforms to generate monitoring reports and manage/conduct clinical trials.

Established effective relationships with clinical investigators and staff to support sponsor programs.Managed activities of clinical investigative sites across multiple protocols with ability to manage with minimal supervision various sites participating in complex and fast-passed clinical studies and/or sites requiring close oversight of operational issues.Ensured quality and timely submission of data from study sites including reporting and follow up of safety events.Ensured successful audit results with no critical findings and regulatory inspection readiness at assigned sites.Resolved conflict with confidence, and win-win solution focus.

Us

Exercised responsibility related to monitoring of multiple projects in coordination with the Regional Field Manager.Interfaced with clinical investigators and other site personnel in order to carry out this responsibility based in the U.S. West Region.Served as home-based monitor responsible/accountable for the identification, selection, initiation, routine monitoring and closeout of investigational trial sites in various programs.Completely accountable for multiple site management and data quality of each site for which was responsible.Conducted monitoring visits according to applicable sponsor SOPs, Working Documents and GCP/ICH guidelines.

Fair Lawn, New Jersey, Us

Performed as a Regional Clinical Research Associate in clinical monitoring.Responsible for completing project activities associated with monitoring functions of Phase I-IV clinical research studies.Performed protocol and investigator site management activities in adherence to all applicable regulatory guidelines and standard operatin procedures.Conducted initiation visits, interim monitoring activities, and closeout visits as appropriate.Assisted in planning and conducting investigator meetings.Ensured that study centers complied with Good Clinical Practices ad ICH Guidelines.Helped seek new opportunities to expand and grow the company in the clinical trials industry.

Thousand Oaks, Ca, Us

Interacted with multidisciplinary teams to implement and maintain systems to implement periodic payments to investigators.Attended workshops and training courses conducive to professional development.Assisted in the development and implementation of various clinical trials.Met with site’s staff representatives to implement subject’s recruitment activities to boost enrollment.Designed a variety of forms and workbooks/spreadsheets, study monitoring tools, data and budget tracking instruments, and coordinated document maintenance to meet regulatory requirements.Implemented periodic payment requests for investigators and Site Management Organizations (SMOs), and other contract service payments for approximately 160 study centers as detailed in their contracts.Represented the company in daily interactions with outside vendors.Helped develop, negotiate, and administer site budgets and grants.Maintained constructive problem-solving attitude while dealing with heavy workloads, time demands, in-complete information or unexpected events.

Managed study start up tasks related to day-to-day monitoring activities.Assumed leadership role in developing and implementing innovative approaches for site recruitment, selection, and initiation processes.Provided leadership and coordinated the efforts of CRA team members related to investigator meetings.Assisted in the development of patient enrollment strategies in collaboration with the project team and clinical trial sites.Provided leadership in assuring the integrity of the clinical data and adherence to applicable regulatory, protocol, and company guidelines.Ensured proper storage dispensation and accountability of clinical trial materials.Recommended and facilitated the efforts of other CRAs in implementing innovative approaches to patient and study status.Completed administrative activities as a member registration in investigator Database.Developed new business opportunities and lead the company while completing site visits.Assumed a leadership role in providing mentoring and clinical technical support for CRAs.Assumed administrative and management responsibilities of sites staff and CRA personnel.Participated in business recruitment, pre-marketing, and marketing activities.Provided direction and participation in quality improvement efforts to increase overall operational efficiency.Functioned as a Lead CRA on projects by providing leadership, supervision, and guidance to project team CRAs, coordinating all project monitoring activities, and communicating status of the activities to CRA Management and Project Management.

Wilmington, Nc, Us

Contributed as a Clinical Research Manager and Senior Clinical Research Associate from a home-based office, regionally based.Assisted in the development and implementation of clinical trials for various therapeutic areas.Evaluated and assessed multiple study sites, and participated in investigator meetings.Conducted CRF data listings review.Assisted in team development, training, and management.Reconciled investigational study drug and assisted in data management verification.Initiated and resolved data queries, and tracked regulatory requirements.Wrote, reviewed, and completed numerous and detailed monitoring reports.

Assisted with the development and implementation of clinical trials for Central Nervous System and Respiratory specialties.Assisted in the design of various forms, study monitoring, data and budget tracking, and coordi-nated document maintenance to meet the sponsor’s SOPs and FDA’s regulations.Participated in protocol specific training and development activities.Provided technical assistance and logistical support to independent and regional monitors assigned to various trials.

Participated in site selection for various clinical trials of investigational drugs and devices.Responsible for ongoing clinical trials of investigational drugs and ensured compliance with FDA regulations.Assured integrity of clinical data with respect to accuracy, accountability, and documen-tation through review of CRFs, source documents, and various aspects of clinical research and pharmaceutical and device product development.

Washington, D.C., Us

Implemented evaluation of ImmunoFluorescence Assay for HIV confirmatory testing in the Americas.Conducted technical assessment and analyzed operational aspects of the national network of laboratories for HIV testing in Colombia, and Venezuela.Developed and finalized numerous technical reports, concept proposals, study protocols, and meeting proceedings.Edited and integrated multiple reports of National Programs for the Control of Chagas Disease in the Americas.Developed proposals and protocols for providing technical assistance to the Ministries of Health of 6 Latin American and English Caribbean countries, emphasizing prevention of infectious diseases and Sexually Transmitted Diseases (STDs).Personal skills commonly utilized in this position included project development and tracking, problem solving, technical writing, public speaking, workshop trainings, public health/epidemiology, laboratory budgeting, and administrative skills.

Established collaborative research and technical assistance in support of AIDS and STD prevention efforts of National Control Programs of 10 countries of Latin America and the Caribbean, and the Philippines.Initiated and managed training and research projects for the AIDS laboratory program including equipment specification, budgeting, staff training, and quality control.Personal skills most commonly used in this position included leadership, organizational, problem solving, scientific creativity, communication, training, and inter-personal relationship skills.

Developed new services and procedures for laboratory testing of milk and water, and upgraded dignostic systems for STD screening in Public Health.Performed routine testing of STDs and infectious diseases, including chlamydia, gonorrhea, and syphilis.Set up procedures for assigned screening and testing, and procured new laboratory equipment and supplies.Help develop plan for relocation and improvement of laboratory services.

Provided bilingual and scientific referral services to the National AIDS Hotline as an Information Specialist.Inputted data and generated daily reports.Personal skills most commonly used in this position included communication and inter-personal relationship skills.

Designed and managed microbiology laboratory, trained and supervised 12 technicians to estimate intensity of vector transmission and human parasitemia of Onchocerciasis in parts of Liberia, West Africa.Served as Field Manager in the development of clinical trials to evaluate the use of Ivermectin.Participated in multicenter international clinical trials to evaluate Ivermectin against Onchocerciasis, sponsored by Merck Sharp and Dohme, and the World Health Organization.

Held progressive responsibilities starting as Technical Assistant advancing to Microbiology Instructor.Lectured, organized experiments, and supervised graduate and medical students in microbiology and entomology as a Microbiology Instructor.Developed and maintained a bibliographic collection on Chagas Disease and assisted in the preparation of medical microbiology and entomology curricula.Accessioned and prepared clinical specimens for chemical and microbiology analysis as a laboratory technician.

Doctor Of Philosophy - Phd, Entomology

Master Of Arts - Ma, Biology

Ba, Pedagogia--Biologia Y Quimica

Hs