Research Associate

SUMMARY

- The Supporting Clinician will provide medical and scientific study and project support for multiple, global, Phase 3 clinical studies in a clinical program.
- They are responsible for working collaboratively with the Lead Study Clinician(s).
- The support includes multiple tasks within the categories of:

PROTOCOL AND STUDY TRAINING

- Specific medical/protocol training for site facing roles including monitors, COL's, and Alliance Partner(AP) staff
- Independently write/design protocol amendments of moderate complexity in collaboration with the Lead Clinician, COSTL, Statisticians, and other relevant groups including Alliance Partners (APs)
- Support the preparation of other clinical documents as required
- DATA REVIEW AND INTERPRETATION
- Proactively coordinate with the Lead Clinician to assure understanding and agreement on deliverables
- Responsible for review of patient level data across a study and coordinating with Lead Clinician for study level review as delegated
- Study analysis and decision point preparation
- Interprets data and is able to identify issues of moderate/difficult complexity
- Conducts data review independently
- STUDY MEDICAL OVERSIGHT
- Collaborates with the Lead Study Clinician(s) and COSTL to provide guidance during the execution of the study
- Provide input into the monitoring plan
- Answer specific site management protocol questions as needed
- Medical issue resolution (study wide, escalated regional/site)
- SAFETY
- Track and reconcile SAEs across a study
- Ensure timely communication of safety issues
- Review and approval of subject narratives as delegated by the Lead Clinician

REGULATORY AND PUBLICATIONS

- Provide input, review and edit clinical study reports (CSR)
- Provide full review of content and integrates information from literature and other sources as appropriate
- Support and contribute to various sections of regulatory filings (Pediatric Investigational Plan, IB, IND/NDA Annual Reports, and PSURs and Regulatory authority responses)
- Audit responses as delegated by the Lead Clinician

CLINICAL PROGRAM IMPLEMENTATION

- Along with the Lead Clinician is accountable for the Medical/Safety and Execution of a Study, with oversight of Alliance Partner activities
- Ensure regulatory compliance and GCP adherence at the study level with regard to medical/scientific issues
- Initiate and coordinate corrective action for major medical/safety/scientific study level issues
- Along with Lead Study Clinician(s) and COSTL and with regard to medical/safety concerns, ensures study level issues are resolved
- Collaborate with Lead Clinician and COSTL to arrive at major site level decisions based on input from the team
- Coordinates with Lead Study Clinician(s) and COSTL to maintain study timelines
- Along with the Lead Study Clinician(s) and COSTL and other study team members, participates in training of Study Management Staff and monitoring staff
- In collaboration with the Lead Study Clinician(s) and COSTL and study team, ensures the clinical trial material requirements of the study are met
- Ensure standard processes, tools, and procedures used consistently and globally
- Participates in developing training strategy for study with the study team members
- Provide input into the preparation of study level training materials in collaboration with Lead Study Clinician(s) and COSTL and team members
- Ensures appropriate filing of documentation in the trial master file.

SKILLS:

EDUCATION AND EXPERIENCE:

- M.D., PhD, Pharm. D. Degree in science or health related field preferred, will consider highly motivated and experienced MA or MS
- 10+ years of pharmaceutical/CRO experience preferred
- Has extensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field
- Has demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents
- Has independently authored clinical study documents
- Has experience with participating in and informally leading an operational team
- Applies knowledge of internal/external business challenges to facilitate process improvements
- Has ability to proactively resolve issues and work independently with minimal supervision
- Has working knowledge of statistics, data analysis, and data interpretation
- Has exceptional written and oral communication and cross-functional collaborative skills
- Is proficient in MS Word, Excel, and PowerPoint Good Laboratory Practices (GLP)