Senior Clinical Research Physician - Oncology

Work Location:
China

Home/Office Based:
Home Based

Req ID#:
8417

Job Title:
Senior Clinical Research Physician (SCRP)

Job Location:
China, homebased

Job Overview:

The SCRP isa medically qualified person without or with limited experience in a drug development/drug safety environment or medical data review.
SCRP works together under supervision of Medical Director or other experienced medical staff in medical monitoring, study design, and regulatory agency interactions.

Activities provided by SCRP include advisory support of medical nature with the aim to ensure the safety and well-being of study participants, integrity of the project data in accordance with the clinical trial protocol/clinical study protocol (or equivalent documents), standard operating procedures (SOPs), good clinical practice (GCP), and all other applicable directives and regulatory requirements.
Responsibilities of SCRP include medical inputs of assigned projects (e.
g.
, clinical trial, clinical study, Non-Interventional Study, Registry study, etc.
) from both a medical and scientific perspective.
SCRP provides and/or oversees medical monitoring activities, including development and/or review of project-specific Medical Monitoring Plans (MMP), Medical Data Review Plans (MDRP) and similar plans, review of other project-specific plans, responding to medically related questions, controlling medical aspects of the questions arising at any stage of a clinical trial and maintaining medical oversight for the conduct of a clinical trial.
The SCRP acts as liaison at study level between the Sponsor/Client responsible for final medical decisions made in a project, the investigational sites, and the project team.
To perform functions, the SCRP may need to be available up to 24 hours/7 days a week as required.
Scope of responsibilities of the SCRP and availability time depends on the contract with particular Sponsor, or it's appropriately authorized designated person (Sponsor/Client).
All services must be provided timely as predefined and within assigned budget (or within allocated time).

Job Duties and Responsibilities:

Job duties differ from project to project and are described in the contract, project-specific Plans (e.
g.
, MMP), and/or other documents agreed with Sponsor/Client.
Job duties also comprise any other tasks as defined by applicable Policies/SOPs/Work Procedures (WPs) and, in general, include but are not limited to the following:

Medical oversight of projects to ensure applicable Policies/SOPs/WPs, Sponsor/Client directives, national and international guidelines are followed.
Providing medical consultation to Sponsor/Client and project team for project activities

Maintaining availability to the site and project team, including the Sponsor/Client, to ensure that medical questions or medical aspects of project-related questions (e.
g.
, safety, general protocol questions, subjects' eligibility, inclusion/exclusion criteria, screening, randomization, unblinding, dosing, termination and discontinuation, drug-specific questions, investigational product/device related questions, etc.
) are answered or communicated for resolution to the appropriate Sponsor/Client's medical resource.
SCRP does not instruct the site how to manage a patient from medical/clinical prospective but advises how to understand protocol and other applicable project requirements

Participation in development of unblinding process in close collaboration with other departments and/or functional groups

Review laboratory results and results of study subject's examinations

Develop/update the written MMP, circulating it for approval within the company and externally (with Sponsor) and maintaining MMP up-to-date at all times during the project, following it and overseeing following it by other team members, escalating cases of deviations from MMP

Develop project-related documents (e.
g.
, clinical study protocol, clinical briefing book submitted to regulatory agencies)

Medical input/review into project documents (e.
g.
, protocol amendments, informed consent, clinical study report, statistical analysis plan, CSR, etc.
) from medical standpoint

Develop and/or review project-related documents and reports; assess and interpret project results

Review medical literatures in the scope of preparation of project-related documents and input for preparation of the respective documents

Review and assessment of issues related to protocol compliance incl.
, protocol deviation/violation, development of corrective and preventative actions

Advice on and participation in management of protocol deviations/violations

Training CRAs and other team members on different topics, including medical and/or safety aspects of the project or therapeutic area/indication

Attendance to internal and external project-specific meetings (e.
g.
, Investigator meeting, Kick-off meeting, regular calls, etc.
)

Attendance at data review meetings (interim analysis and final data analysis)

Attendance at and services related to DSMB organization and management, creation of a DSMB charter, memo preparation, etc.

Medical review of subject's data (presented, e.
g.
, in the format of listings, patient's profile, etc.
) aiming for identification of non-reported AE, clearing the data, clarifying and resolving data inconsistencies, query management, etc.

Participation in Determination of dose escalation

Review of Medical Coding to ensure medical reasonability of the codes and re-coding items if it is appropriate

Review of the requests from Regulatory Authorities and/or Ethic Committees/IRBs and related activities (preparation of responses, participation in meetings, etc.
) when requested

Ensures appropriate safety considerati.