Your Name

• Served as Clinical Project Team Representative (PTR) for a large global acne program

- Ensured study CPMs were within budget and timelines and mitigated deviations to program objectives

- Ensured operational consistency across the Long Term Safety Study and the two Phase III studies

- Led program workshop and presented plan for implementing lessons learned from LTS and efficiencies to be gained in start-up of pivotal studies

- Developed strategy and obtained cross-functional buy-in for a plan to optimize activities and resources due to overlapping study end timelines for pivotal studies and LTS in order to achieve NDA submission target 

• Served as Clinical PTR for a Phase IV Post Marketing Requirement (PMR) psoriasis program

- Key participant in informal teleconference with FDA regarding program challenges. Communicated clinical recruitment obstacles and contingencies which contributed to Agency's decision to release company from original PMR to be replaced by a new PMR with LTS re-design

- Extensive information provided for the IND and NDA annual reports to document metrics related to recruitment challenges, number of sites contacted/declined, prescreening efforts and reasons for non-eligibility.

- Effectively led team to present organizational changes to program management to help streamline activities across the studies, look for ways to reduce/optimize costs, and to present additional recruitment contingencies 

• Successfully completed protocol amendment, CRO Work Order execution, and study start up activities including CRO KOM and site feasibility for 1200 subject Phase III acne study in a 2 month timeframe to accommodate a late management decision to accelerate FSI target by 5 months

• Mentored junior CPMs
  
• Led multi-disciplined committee in developing and implementing a standard protocol template
• Presented program status as Clinical PTR and study status as CPM during monthly Clinical Trial Operational Governance Committee meetings. Presented at Clinical Trial Executive Governance Committee meetings as needed
• Executed CPM core responsibilities as described below

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• Successfully executed two phase 3 pivotal trials (1372 subjects across 100 sites) and locked database 2 weeks post Last Subject Out to meet advanced timelines for NDA submission Note number of months NDA submission accelerated and impact to DBL and other study end timelines and how did this - database lock - batch subjects - and how much data orig reviewed when began endeavor- Led clinical operations team during mock inspection of phase 3 program and received positive feedback, initiated and completed resolutions to findings, and managed CAPAs; prepared sites for FDA audits Successfully accelerated timelines for a phase 2 study in order to maintain program objective despite added complexities in study design after CTO/protocol finalization-Delivered a PRC-approved protocol after a Regulatory decision to include the document in the FDA briefing package with only 1 month notice- FSI achieved only 2 months after CRO contract signature - Developed and executed recruitment contingencies to successfully mitigate difficult enrollment of severe acne subjects without compromising study end timelines Managed largest PK study in Galderma (4 arms, 102 subjects)- Start-up activities completed within 4 months after FSI was shifted 1 month earlier to fast track NDA submission- Exceeded original study timelines by 2 months despite trial complexity and site/subject recruitment challengesManaged first two pivotal device studies (wrinkle severity) at Galderma - Efficiently managed project challenges and delays and achieved Last Subject In two weeks ahead of scheduleFunctioned as Clinical PTR for five programs across psoriasis, dermal filler devices, and acneDeveloped data batch cleaning timelines to be utilized by Clinical Operations as a standard in large studies to reduce database lock timeframeAuthored CSR SOP, Production of an eCSR Instruction, and Protocol numbering Instruction 
  
• Effectively functioned as the Clinical Project Team Representative across 5 programs

- Ensured the development strategy as outlined in the GIDP was 

-Communicated project objectives, status, and important issues to Clinical Operations management and to study CPMs 

-Communicated progress of studies to Global Project Team including potential significant changes to timelines and budget along with contingencies and any significant impact/delays to project objectives

- Provided clinical content for the IND/IDE, IND and NDA annual reports, Briefing Packages, PSUR, DSUR, and Investigator's Brochure​

• Supervised and coordinated mono- and multi-center clinical trials to ensure study design and conduct were in line with internal SOPs, GCP, and local and international regulations

• Authored clinical protocols based on the Clinical Trial Outline (CTO) approved by the internal Outline Review Committee (ORC) and in line with the project development plan. Presented and defended the protocol design to the internal Protocol Review Committee (PRC)
• Established budget, timelines, and detailed planning for study conduct and took appropriate actions to limit any variances
• Led the clinical study team during regular meetings
• Approved the final selection of study investigators
• Authored Clinical Trial Quality Plan, Clinical Trial Operational Management Plan, and Communication Plan. Reviewed and approved other study plans as appropriate (e.g., Project Plan, Monitoring, Protocol Deviation Management Guideline, DMP, EDC Plan, EDC Training and Account Activation Plan, Translation Plan)
• Organized and led study training including Kick-Off Meeting with CRO and Investigator Meeting
• Ensured necessary pre-requisites for trial conduct were in place prior to initiation 
• Worked with Clinical Supplies Unit (CSU) to establish and approve the parameters for IWRS build, and study supplies labeling, packaging, and delivery to study sites 
• Reviewed and approved the CRFs, Data Management Plan (DMP), edit check specifications                        
• Provided input to Statistician for development of the Statistical Analysis Plan (SAP)                        
• Collaborated with Statistician, Data Manager, and Medical Advisor to create the evaluability criteria and identify the Per Protocol (PP) population. Led evaluability meeting and issued minutes                        
• Responsible for providing the scope of services for CRO outsourcing to Contracts Group and acted as key participant in CRO selection                        
• Tracked financial expenses and worked in collaboration with the Contracts Group and vendors to perform periodic reconciliation of contracts                        

• Ensured timely and complete reporting of SAEs, pregnancies, and AEs of Special Interest (AESI). Participated in periodic internal safety review meetings          
• Responsible for initiating the CSR writing process and led the CSR KOM to establish timelines, identify key reviewers, discuss resourcing needs, and completion of CSR matrix                        
• Coordinated responses to audit reports and implemented appropriate actions     
• Devised enrollment plan detailing potential obstacles and contingencies              
  
• Presented study status at monthly meetings                         
• Participated and presented at CPM Peer Information and Knowledge Exchange Meeting    

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• Led and managed operational tasks for a global Phase 3 study (48 sites X subjects), Phase IV PK study (2 sites, 50 subjects), and Phase 2 PK study (1 site, 20 subjects)
• Phase IV PK study recruitment achieved in 2 1/2 months
• Assisted CPM with planning study logistics and starting a Phase 2 PK study within 1 month of study transition after company acquisition 
• Oversight of 1 internal and 2 external CRAs assigned to the PK studies 
• Reviewed Phase IV PK study protocol for operational feasibility; Re-wrote protocols for 3 dermal safety studies 
• Ensured investigational sites and CRAs were compliant with study protocols, study specific plans, SOPs and ICH/GCP/regulatory guidelinesConducted site feasibility and coordinated selection of investigators
  
• In collaboration with the CPM, made recommendations for outsourcing of any required functions (e.g. monitoring, laboratory services etc.)
• Assisted the CPM with preparation of bid grids and budgets
• Participated in selection of CRO and other third party vendors; assisted with review of proposals  
• Developed study documentation (e.g., ICF, Monitoring Plan)
• Conducted CRA training meetings and ensured training of CRAs completed by CRO were adequate in relaying monitoring and study requirements 
• Verified all regulatory approvals were obtained before site initiation 
• Ensured all sites had sufficient clinical trial supplies and other study materials
• Tracked recruitment and ensured recruitment targets were met
• Collaborated with CPM/Sr. CRA to identify issues, trends, resolutions and/or corrective actions
• Supported CPM and QA to facilitate the conduct of site audits. Confirmed responses to relevant audit findings were complete and corrective actions were taken, as appropriate. 
• In conjunction with the CTA, confirmed all appropriate documentation was maintained in the TMF on an ongoing basis and performed QC of study files prior to TMF archiving at study end 
• Verified all protocol deviations were captured and managed according to study plans
• Communicated study progress and any significant deviations and trends to the CPM in a timely manner
• Ensured timely data entry and resolution of data queries 
• Ensured timely and complete reporting of SAEs, AESIs, and pregnancies according to agreed procedures; ensure appropriate monitoring and reconciliation of documents in-house and on site   
• Ensured the quality of monitoring activities through review of CRO/contract CRA monitoring reports and performing co-monitoring visits. Appropriate action plans were put in place for any quality or compliance  concerns and escalated to CPM  
• Escalated site and CRO performance issues and proposed corrective actions to the CPM 

• Effectively coordinated study management and trial activities for a phase 3 acne study after assuming responsibilities during CTM's leave of absence 
• Assisted CPM with managing the sites, CRO, and laboratory for an HPA axis suppression study and met/exceeded milestones
• Completed study start up activities in 3 months for an adolescent PK study
• Actively contributed in CRO, central lab, and home care agency selection through completion of bid grid, review of CRO proposals, and participation in bid defense meetings
• Functioned as team lead for site selection process and provided final list of potential investigators to CTM/CPM; Experience with conducting feasibility/pre-study visits in Puerto Rico and Brazil
• Assisted in coordination and organization of technical training and conducted presentatons at Kick-off meetings, Investigator meetings, CRO/CRA training meetings
  
• Assisted in review and finalization of CRFs and source documents
• Developed subject documents (e.g., ICFs, subject instructions), monitoring tools, and tracking logs 
• Assisted CTM/CPM in project planning including review of study plans 
• Managed, tracked and documented CRO CRA activities by reviewing monitoring reports, tracking on-site visit frequency and duration, and conducting co-monitoring visits; Reported site status, significant protocol deviations and issues to CTM/CPM with proposed resolutions
• Tracked subject enrollment and retention and collaborated with CTM/CPM to identify issues, trends, and resolutions
• Assisted with data query resolution 
• Followed up with CRO and/or sites on lab abnormalities, AEs, SAEs, and pregnancies; Performed SAE reconciliation between the Clinical and Safety databases
• Generated and tracked milestone payments per Investigator Research Agreement
• Supported CTM/CPM by reviewing data listings and subject profiles in preparation for evaluability meeting
• Trained and mentored junior CRAs

• Monitored Phase I-III dermatology clinical research trials to ensure adherence to study protocol and FDA GCP and ICH guidelines
  
• Reviewed CRF design and provided input to Project Manager and Data Manager
• Worked with study team to develop, review, and finalize source documents and ICFs
• Developed monitoring tools to track subject profiles, enrollment, CRFs reviewed/retrieved, protocol deviations, adverse events, and regulatory documents
• Generated instruction sheets outlining critical study information for trial sites
• Collaborated with study team and site personnel to complete study start up activities (e.g., obtain study documents, ensure adequate supplies, etc.)
• Performed all functions associated with conduct of pre-study, initiation, monitoring, and closeout activities
• Oversight of trial sites including identification/resolution of issues, verification of proper study conduct, and communication of study progress and updates
• Reviewed investigator files in Trial Master File in preparation for internal/external audits and study archiving
• Addressed audit findings with trial sites for resolution or communicated to CRO CRAs (when applicable) for action 
• Worked with site personnel and Data Management to resolve queries in a timely manner
• Followed up on AEs, SAEs, and pregnancies reported at trial sites
• Reported progress of trial sites to Project Manager and study team during internal study meetings
• Served on SOP committee to prepare, develop, and review Clinical SOPs (authored Advertising SOP)
• Generated report templates for pre-study, initiation, monitoring, and closeout visits for use by Galderma CRAs
• Functioned as Lead CRA on acne PK study
• Assisted in preparation of NDA 120-day safety update report for FDA submission
  

• Shared same core responsibilities as a CRA I (see below)
• Assisted Lead CRA with development of tracking tools and visit guidelines
• Assisted Lead CRA with review of visit reports submitted by other CRA study team members 
• Experienced with rescue projects that included re-monitoring and closing sites managed previously by other CRAs
• Served as a mentor for less experienced CRAs
• Monitored studies for overactive bladder and osteoarthritis

• Completed project activities associated with monitoring functions of Phase I-IV research studies
• Managed study site activities to ensure integrity of clinical data, in adherence to all applicable regulatory guidelines and SOPs
• Completed pre-study activities to identify and evaluate potential investigators
• Conducted initiation visits with study staff through training of protocol, subject screening/randomization procedures, IRB submission process, and SAE/pregnancy reporting requirements, review of investigator site file, and drug accountability 
• Performed monitoring visit tasks including source document verification, CRF review/retrieval, investigator site file review, and ensuring proper AE/SAE reporting and proper study drug storage, dispensation and accountability in accordance with the project plan
• Verified the Investigator and study staff were performing trial functions in compliance to protocol and delegation of authority
• Completed in-house monitoring activities including updating in-house site files, completing visit reports, and following up with sites
• Collected, reviewed, and tracked regulatory documents
• Maintained tracking records for assigned sites including investigator site file contents, enrollment status, subject summaries, CRF review/retrieval, and query status
• Completed study closeout visit tasks including reconciliation of in-house and site investigator files, study drug return, and ensuring study staff understand the policies and procedures for study record retention, AE follow up, and IRB notification of closeout
• Communicated with study staff to provide trial updates, identify and resolve ongoing issues, and acted as liaison between Sponsor and Investigator
• Provided site status to Lead CRA and Project Manager
• Completed investigator payment worksheets and submitted to PM for site payments
• Participated in study specific training including training teleconferences, study kick-off and investigator meetings

• Assisted CRAs in the conduct of all aspects of clinical studies
• Prepared necessary study materials and documents for study initiation through closeout
• Assisted with on-site monitoring duties and compiled documentation including Investigator Site File review and reconciliation with Trial Master File, query resolution, CRF retrieval, and drug accountability
• Assisted in preparation of visit reports, confirmation and follow up letters
• Communicated with study sites