Job SummaryThe study physician is a responsible member of the clinical team providing medical expertise and medical oversight for the entire clinical trial, from initial study design through final study close-out. The medical monitor provides active medical contribution to a cross-functional clinical team for each study assigned in early development. The medical monitor is responsible for the medical monitoring, safety activities, assessment and understanding of drug induced safety findings in light of patient safety for each assigned trial.
Essential Functions- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Close supervision of external contract organizations who will have responsibility for site interaction, site monitoring, data management, biostatistics, IRB interaction, central laboratory function, clinical research budget negotiation, medical writing, pharmacovigilance, and other critical activities
- Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
- Maintains oversight of the conduct of the studies at the study centers (site selection, start up, monitor adherence to protocols and Good Clinical Practices (GCP), applicable guidance and study closure)
- Lead sponsor study process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
- Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
- Proactively manage project level operational aspects of Clinical Trial Team (CTT) including management of trial timeline, budget, resources and vendors.
- Vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
- Establishes and maintains good working relationships with clinical study site personnel to ensure adherence to protocols and Good Clinical Practice (GCP), provision of quality data and adherence to study timelines
- Oversees and support Clinical Site Manager(s)/CRAs in the conduct of the trials
- Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
- Review and approve vendor invoices in collaboration with the accounting team to ensure investigator payments occur in a timely manner.
- Collaboration with the Director of Quality and Compliance review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
- Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.
- Accountable for developing and managing the Clinical Operations budget.
- Review draft protocol and coordinate operations in order to meet protocol requirements.
- Oversees EDC/CTM entries and provide appropriately QC'd study raw data to Medical Writing team for report completion.
- Perform quality control of clinical reports by utilizing protocol and procedural deviations reports, sample inventory, and medical writers.
- Confirm study medication is received and dispensed for assigned projects in a timely manner.
- Coordinate study monitor visits, including file review and follow-up of findings/concerns.
- Other projects or responsibilities as may be required.
Qualifications:- Experience in designing clinical trial plans, organizing clinical trials, and writing summary reports independently.
- Knowledge about research administration, experience with investigator initiated trials.
- Substantial knowledge and understanding of federal regulations affecting clinical trials and medical research is preferred.
- Knowledge of and experience in experimental design, and basic understanding of statistics and statistical methods is required.
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- Good therapeutic and protocol knowledge.
- Strong knowledge of clinical research financial parameters and project financial tracking and accounting methods.
- Strong communication and interpersonal skills.
Minimum Qualifications - Education and Experience- Trained and certified as MD (or equivalent), preferably a minimum of 3 years of experience in medical monitoring of clinical trial
