Clinical Trial Specialist Resume
Objective : As a Clinical Trial Specialist, worked closely with the research team to help coordinate the approval processes and conduct of research protocols, ensuring that the integrity and quality of the research were maintained and that the research was conducted according to Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, GHCR policies and procedures, and research protocols.
Skills : Analytical Skills, Attention to Detail.
Description :
- Assisted in the management of subjects on clinical trials and coordinating activities associated with clinical trials under the mentorship and guidance of a Clinical Trial Specialist II.
- Managed and executed the day-to-day operations of complex Phase I-IV clinical research protocols in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
- Managed and led cross-functional study teams, including vendors.
- Liaised with other functional areas (preclinical development, pharmaceutical sciences, safety, and regulatory affairs) to accurately coordinate clinical study activity.
- Provided a second check for patient eligibility to clinical trial, following review by a research nurse, including a second check of inclusion/exclusion requirements and eligibility criteria.
- Coordinated and attended regular monitoring visits and closeout visits.
- Maintained informed consent records of each patient for the duration of the study.
Experience
2-5 Years
Level
Executive
Education
Bachelor's Degree in Life Sciences
Clinical Trial Specialist Resume
Headline : As a Clinical Trial Specialist, managed clinical operations site payment system, prepared site invoices and supporting documentation, and initiated/created clinical/regulatory department Purchase Orders, trained laboratory personnel, background in immunology or oncology strongly preferred.
Skills : Communication Skills, Project Management.
Description :
- Managed Site Essential Documents review during study start-up, maintenance, and close-out period.
- Prepared study documents (consent forms, site instructions, and study-specific materials such as the Manual of Operations, and Pharmacy binder).
- Ensured tracking of essential documents were received and filed in the CTMS, reviewed site documents for accuracy, and provided clinical team support with CTMS filing and management.
- Ensured tracking of patient status throughout the study at investigative sites.
- Reviewed and approved trip reports, tracked data query reports, site visit metrics, and overall site performance.
- Performed routine monitoring at limited clinical sites.
- Attended and oversaw Site Initiation Visits.
Experience
5-7 Years
Level
Executive
Education
Bachelor's Degree in Life Sciences
Clinical Trial Specialist Resume
Headline : As a Clinical Trial Specialist, working with the clinical teams to help plan/design and execute biospecimen handling logistics.
Skills : Regulatory Knowledge, Problem-Solving.
Description :
- Engaged with preferred vendors associated with sample collection kits and execution of associated logistics including quality oversight and rapid reconciliation of biospecimens.
- Worked with the Clinical Assay Team and analytical laboratories on work order requests and logistics about specimen deployment.
- Developed, maintained, and managed appropriate study documentation.
- Collected, reviewed, and approved regulatory documents from clinical sites.
- Maintained and reconciled Trial Master File.
- Provided logistical support for the study team with the maintenance of tracking systems and tools, managing the preparation of necessary materials, and being responsible for recording and distributing minutes.
- Developed study protocols, informed consent forms, and other trial-related documents.
Experience
5-7 Years
Level
Executive
Education
Bachelor's Degree in Health Sciences
Clinical Trial Specialist Resume
Objective : As a Clinical Trial Specialist, worked knowledge of transplant patient care and apheresis collection a plus, and participated in internal audits/client meetings with support.
Skills : Technical Skills, Organizational Skills.
Description :
- Prepared and submitted IRB/IEC application and follow up until final approval received (initial submission and amendments).
- Conducted country specific feasibility and/or site pre-qualification.
- Interacted professionally with external customers.
- Influenced and negotiated resolutions and outcomes with sites.
- Worked independently with little oversight and to proactively seek guidance when necessary.
- Provided biospecimen management for company sponsored clinical trials in oncology.
- Assisted in the design and planning of clinical trials.
Experience
2-5 Years
Level
Executive
Education
Bachelor's Degree in Health Sciences
Clinical Trial Specialist Resume
Objective : As a Clinical Trial Specialist, ensured the quality of the data generated from clinical sites and assisted in resolving subject eligibility and protocol deviation issues.
Skills : Regulatory Knowledge, Project Management.
Description :
- Expanded brand and disease area awareness through national congress mapping and increased study report dissemination.
- Ensured compliance with ICMJE guidelines for the review and publication of scientific material.
- Collaborated with medical advisors, to develop the publication strategy for key assets in oncology, cardiovascular, virology, and immune-mediated inflammatory diseases.
- Managed publication projects from inception to final publication (abstracts, presentations, manuscripts) in collaboration with investigators, writing agencies, and biostatisticians.
- Participated in phase III and IV research projects and maintained an updated book of work on ongoing Canadian clinical trials (investigators’ sponsored research trials, outcome research studies, and BMS-driven studies).
- Independently prepared and negotiated clinical site agreements at a site level, including PREDICT Agreements, and Letter of Indemnifications (LOIs).
- Provided training, as necessary, at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences.
Experience
2-5 Years
Level
Executive
Education
Bachelor's Degree in Life Sciences
Clinical Trial Specialist Resume
Summary : As a Clinical Trial Specialist, provided specialized and technical reviews of clinical trial research protocols, funding agreements, and billing processes, and administered, organized, and conducted training/educational programs in connection with clinical trial operations, systems, and management.
Skills : Data Management, Communicational Skills.
Description :
- Maintained records of training activities, progress, and program effectiveness.
- Ensured distribution and maintained inventory required for the execution of research protocols.
- Assisted in the determination of guidelines for new protocols.
- Collected and prepared data for various clinical trial-related reports.
- Compiled reports, documents, and correspondence for regulatory agencies, participating clinical trial sites, and internal departments to monitor and evaluate progress.
- Developed, coordinated, and conducted training in collaboration with clinical trial subject matter experts.
- Served as liaison between clinical trial management systems end users and management systems support team.
Experience
7-10 Years
Level
Management
Education
Bachelor's Degree in Life Sciences
Clinical Trial Specialist Resume
Headline : As a Clinical Trial Specialist, maintained oversight for the completion of study-specific training across functional areas, and supported the clinical team with ad hoc requests as needed, from study start-up through study closure.
Skills : Clinical Monitoring, Protocol Development.
Description :
- Upheld a professional interpersonal relationship with the study team, sites, and sponsors.
- Demonstrated proficient knowledge of FDA regulations and ICH-GCP guidelines, as applied to both premarket and post-market studies.
- Assisted in creating and maintaining study-specific laboratory manuals and provided training to clinical site personnel on laboratory procedures and manuals.
- Kept manager informed about work progress and any issues (including conflicting priorities and free capacity).
- Performed site initiation, routine monitoring,g and close-out visits at a limited of clinical sites, as well as co-monitoring with local CRAs.
- Coordinated the activitiesofmthird-partyy vendors including metrics, accruals, process planning, and implementation.
- Facilitated delivering clinical and biomarker data on active trials to achieve corporate goals.
Experience
5-7 Years
Level
Executive
Education
Bachelor's Degree in Life Sciences
Clinical Trial Specialist Resume
Headline : As a Clinical Trial Specialist, working knowledge of the clinical drug development process, along with ICH-GCP guidelines and FDA regulations, assisted with site management activities, including communicating with sites to collect regulatory documents, support IRB submissions, discuss screening/enrollment activities, and other project-specific requirements.
Skills : Attention to Detail, Ethics, and Compliance.
Description :
- Maintained study-level timelines and data entered into PERI systems.
- Created and assisted with the maintenance of Trial Master File and project files, including participation in TMF audits.
- Prepared and maintained site manuals, reference tools, and other project-specific documents.
- Requested and managed project-specific system accesses for internal study teams and sites.
- Aided with coordination of team meetings, including preparing meeting minutes and action items.
- Contributed to vendor management in tandem with the Clinical Trial Manager, including maintaining sample tracking logs.
- Updated study dashboards, status trackers, and other applicable study documents to provide regular updates on trial status.
Experience
5-7 Years
Level
Executive
Education
Bachelor's Degree in Life Sciences
Clinical Trial Specialist Resume
Summary : As a Clinical Trial Specialist interacted with and influenced all levels within Clinical Operations and other clinical study personnel for clinical trials across portfolios and platforms, in addition to working with the Process Excellence group to resolve any ambiguities and inconsistencies in interpretations of standard processes and forms and implements a consistent approach across the team, provides input to process updates and recommends the development of new processes as needed.
Skills : Technical Skills, Interpersonal Skills.
Description :
- Interacted with other key functions to ensure the group had the tools required to execute job responsibilities efficiently.
- Balanced assignments and workload across the group, identified Subject Matter Experts within the group on the core activities and systems to help onboard new members and provide training to the group and others as needed.
- Provided SCT guidance and support during internal audits, vendor audits, and hosting inspections.
- Supported adherence to the regulatory requirements, the ICH-GCP guidelines, and the respective procedures (policies, SOPs, instructions) to help ensure team inspection readiness.
- Played a key role in accomplishing tasks and projects that are instrumental to the successful execution of assigned programs.
- Worked closely with the project Clinical Trial Manager (CTM) for the timely delivery of recurrent tasks consistently with a high degree of accuracy.
- Compiled and maintained project-specific status reports, interacted with the sponsor, study sites, and internal associates, and provided oversight and quality control of our internal regulatory filing system.
Experience
7-10 Years
Level
Management
Education
Bachelor's Degree in Life Sciences
Clinical Trial Specialist Director Resume
Summary : As a Clinical Trial Specialist Director developed and updated work practices and activities for the department as needed and oversees the implementation of new systems, working with the system implementation group to help identify the business rules for the SCT group with new systems.
Skills : Training and Development, Interpersonal Skills.
Description :
- Worked with the training group to identify and develop competency-based training and task-specific training for the group.
- Assessed resource forecast and allocation across the portfolios and is responsible for proactive interviewing, hiring, onboarding, and assignment of peer partners for the group, as well as supervising the onboarding process.
- Developed and promoted talent within the group.
- Implemented an SCT best practice forum to provide training and updates to processes on a timely basis, as well as to identify areas for implementation of efficiencies.
- Oversaw the completion of the designated tasks to the SCT group members by trial teams to ensure execution per expectations.
- Served as the point of escalation for the SCT group in case of challenges in project activities and helped negotiate resolutions with stakeholders.
- Provided and mentored the SCT group on ICH-GCP and other regulations to ensure the group is current in clinical development and industry best practices.
Experience
7-10 Years
Level
Management
Education
Bachelor's Degree in Life Sciences
