Responsibilities
1. Reports to CEO, and works in coordination with Director of Clinical Operations, members of the clinical team, and other areas of operations as needed.
2. Review and provide input for protocol development.
3. Interacts with clinical specialists, study chairs or other or sponsor representatives.
4. Interact in a team approach to develop statistical and data management sections of the protocol; reviews the final protocol for clinical, safety and efficacy variables;
5. Review and / or assist in the preparation of final study reports (CSRs), or other study documentation (integrated summary of safety and integrated summary of effectiveness (ISS/ISE) etc.);
6. Provide therapeutic and protocol-specific training on therapeutic indication and/or treatment modality to the project teams; contribute medical input into the design of clinical development programs and research papers etc;
7. Provide medical oversight as the first line of medical monitoring support for clinical trials and ongoing clinical trial management;
8. Review Serious Adverse Events (SAEs); demonstrate competence with the execution of SAE related medical review and safety monitoring;
9. Review IND/SUSAR Safety Reports, updates to Investigator Brochures, and annual IND reports with sponsor data;
10. Develop project medical monitoring plan;
11. May provide study team with assistance in developing criteria for investigator site selection and networking for potential investigators for study participation, and aid in review and final selection;
12. Provide medical review of eCRFs and edit check specifications for clinical accuracy;
13. Interact with regulatory officials concerning safety and other study related issues;
14. Perform medical review of coded terms (e.g. adverse events, concomitant medications and medical history) for medical accuracy and consistency along with the laboratory data.
Qualifications
1. Current license to practice medicine; board certification; up-to-date on practice of clinical medicine.
2. Ability to work both independently with minimal supervision and to work effectively within a team;
3. Ability to support multidisciplinary clinical trial operations;
4. Ability to organize and work efficiently on several projects, involving different disciplines and/or shifting priorities;
5. Excellent oral and written communications skills as well as interpersonal skills;
6. Ability to travel domestically and internationally as (infrequently) required.
1. Reports to CEO, and works in coordination with Director of Clinical Operations, members of the clinical team, and other areas of operations as needed.
2. Review and provide input for protocol development.
3. Interacts with clinical specialists, study chairs or other or sponsor representatives.
4. Interact in a team approach to develop statistical and data management sections of the protocol; reviews the final protocol for clinical, safety and efficacy variables;
5. Review and / or assist in the preparation of final study reports (CSRs), or other study documentation (integrated summary of safety and integrated summary of effectiveness (ISS/ISE) etc.);
6. Provide therapeutic and protocol-specific training on therapeutic indication and/or treatment modality to the project teams; contribute medical input into the design of clinical development programs and research papers etc;
7. Provide medical oversight as the first line of medical monitoring support for clinical trials and ongoing clinical trial management;
8. Review Serious Adverse Events (SAEs); demonstrate competence with the execution of SAE related medical review and safety monitoring;
9. Review IND/SUSAR Safety Reports, updates to Investigator Brochures, and annual IND reports with sponsor data;
10. Develop project medical monitoring plan;
11. May provide study team with assistance in developing criteria for investigator site selection and networking for potential investigators for study participation, and aid in review and final selection;
12. Provide medical review of eCRFs and edit check specifications for clinical accuracy;
13. Interact with regulatory officials concerning safety and other study related issues;
14. Perform medical review of coded terms (e.g. adverse events, concomitant medications and medical history) for medical accuracy and consistency along with the laboratory data.
Qualifications
1. Current license to practice medicine; board certification; up-to-date on practice of clinical medicine.
2. Ability to work both independently with minimal supervision and to work effectively within a team;
3. Ability to support multidisciplinary clinical trial operations;
4. Ability to organize and work efficiently on several projects, involving different disciplines and/or shifting priorities;
5. Excellent oral and written communications skills as well as interpersonal skills;
6. Ability to travel domestically and internationally as (infrequently) required.