clinical research coordinator case manager resume example

• Provided operational supervision, and leadership in implementing and managing of clinical trials.
• Through all periods of trial conduct including trial set-up, execution, analysis, reporting, and closeout.
• Responsible for quality and ‘on time’ delivery of clinical deliverables.
• All activities are conducted in accordance with the appropriate quality standards including ICH-GCP Guidelines, SOPs, applicable regulations, rules, templates, and work instructions Processes etc.) and as appropriate contributed to Department Managers’ meetings.
• Communicated effectively with Project Team members i.e., Clinical Team Leader, Project Managers, Safety and Data Management, to ensure study completion per company and client requirements and timelines.
• Being a proactive member in team calls and act as a role model.
• Coordinated quality review, and final reconciliation of study documents including review of sites regulatory documents and obtaining of appropriate country insurance.
• Led site meetings and gave presentations at the meetings.
• Worked in a timely manner in accordance with all the activities specified in the agreed study budget, under the supervision and guidance of the LCRA and Project Manager.
• Undertook other project related administrative tasks (i.e., meeting minutes, recruitment tracking, site file Preparation) as appropriate, as assigned by the Project Manager and LCRA.
• Documented all study activities including investigator contacts using relevant forms.
• Liaised with appropriate departments within Company to ensure the smooth running of the study.
• Ensured awareness of project-specific quality and performance standards (within Clinical Monitoring Standards) and ensured that these are adequately documented, communicated, and understood.
• Actively participated in training sessions and workshops.

• Set-up, delivers, and close-out clinical trials including training study staff, managing vendors, and general Clinical trial oversight in collaboration with the PI, Clinical trial lead and Project Manager.
• Function as a first line contact for field and/or study site personnel for study protocol and/or study conduct questions.
• Coordinated efforts from study start-up through close-out, including collection and review of regulatory documents.
• Tracked patient recruitment by contacting investigators as specified for the study and discuss potential study risks and opportunities with the Project Manager and LCRA.
• Ensured quality and data integrity by applying the ALCOA+C guidelines, compliance with company and/or Sponsor’s SOP, ICH/GCP, and regulatory requirements.
• Ensured study completion on time, confirmed all Adverse Events (AE)/Serious Adverse Events (SAEs) are reported within the required reporting timelines and detailed as appropriate.
• For AEs/SAEs, made sure that they are consistent with all data collected and with the information in the source documents.
• Tracked completed CRF’s and setting up systems whereby completed CRFs are rapidly entered into database.
• Maintained site’s regulatory binder and corresponding eTMF.
• Provided study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines.
• Performed SDV’s, initiated data query resolution, and confirmed resolution in a timely manner.
• Maintained a level of accuracy that minimizes data query rate and ensured data are accurately and transcribed to meet SOP and audit expectations.
• Provided initial review of monitoring trip reports, ensuring timely, accurate, and complete reporting of study conduct.
• Developed and maintained SOPs for monitoring functional area and serve as a resource for questions related to monitoring, administrative tasks, and SOPs/business processes.
• Interacted directly with contract research organizations (CROs), contractors, and other vendors to ensure consistent implementation and successful completion of clinical research activities.
• Completed required case report forms and resolves queries.
• Ensured accurate data collection, documentation, and safety of study volunteers.
• Ensured accurate regulatory filing, supported other team members and facilitated team cohesion; played an active role in site personnel training to meet study requirements.

• Demonstrated excellent organizational skills in addition to the technical skills required for coordinating and verification of all in-house documents generated by study sites, monitors and other related sources involved in clinical research studies.
• Assisted Clinical Trial Manager in identifying opportunities research workflow process.
• Improvement, providing recommendations, and contributed to achieving department and hospital targets for quality and safety.

EDUCATION

• Maintained a level of accuracy that minimized data query rate and ensures data are accurately.
• Transcribed to meet SOP and audit expectations.
• Reviewed study and researched documents for completeness and accuracy in accordance with ALCOA+C guidelines.
• Served as a point of contact for field-based monitors and study sites.
• Tracked study documents to be uploaded to electronic trial master file.
• Assisted in the planning and organizing of investigator meetings and trainings.
• Proactively identified study related issues that arise from time to time and provided recommendations for resolution.
• In-house tracking of activities at study sites to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOP) and all study protocols.
• Collected, reviewed, and processed regulatory documents from investigator sites.
• Participated in projects team meetings, prepared all site documents and visit reports for filing in the Trial Master File.
• Assisted in other areas of clinical study projects as may be assigned.
• Met timeline of ensuring all pages entered in EDC to meet Database lock.
• Performed drug accountability and return of specimens to biostorage.
• Provided sites training for temperature deviation.
• Ensured PI signed off on all source documents and have adequate communication with Monitors.
• Performed clinical research support functions as assigned by the clinical trial manager including but not limited to informed consent for both interventional, non-interventional studies, data abstraction and recording in CRFs.