Summary of the Position:
The Research Physician is responsible for communicating with team members regarding the medical aspects of trial conduct, with particular emphasis on clinical interpretation, intervention, and review of medical information and results as well as the significance and impact thereof. Interact proactively with clients on medical and related issues during all phases of projects. Provide professional services relating to medical input into protocols, investigational drug safety, safety monitoring, and other pharmacovigilance-related activities. Apply medical knowledge and experience to the review and assessment of medical and safety data during trial conduct and post-trial analysis. Train and advise project team members on project-related medical issues, as warranted. Ensure adherence to all relevant and current clinical medical policies, directives, rules, regulations, and clinical performance standards of medical ethics and legal requirements of accrediting bodies.
Essential Functions:
Contribute to the development and review of protocols and their amendments.
Answer trial-related medical questions and interact with Clinical Operations and Regulatory Affairs colleagues, investigators and other site personnel on medical matters.
Review and advise on participant eligibility in consultation with Sponsors, as applicable.
Ongoing data review (including participant, safety, coding and protocol deviation/violation listings) and advise accordingly based on significance and/ or potential trial impact.
Review Data and Safety Monitoring Board (DSMB) reports.
Perform other functions of a medical monitor as defined for specific projects, including but not limited to development of Medical Monitoring Plans and eCRF input or review to ensure appropriate capture of medical data.
Perform, manage, co-ordinate and oversee trial-specific pharmacovigilance activities in collaboration with the designated project Safety Officer, including but not limited to:
- Oversight of the development, review, and approval of Safety Management Plans and related safety reporting forms
- Oversight of the development of and training on the electronic safety reporting system and safety databases
- Serious Adverse Event (SAE) and other safety event medical triage, review, evaluation, and querying
- Oversight of and support to Safety Officers for the receipt, safety triage, review, querying, tracking and follow up of SAEs and other safety events
- Ensuring appropriate safety reporting to investigational sites, regulatory authorities, and independent ethics committees
- Advising on the appropriate management and/ or escalation of reported safety data in terms of trial endpoints, pause criteria and/ or Safety Data committees such as a DSMB, Protocol Safety Review Team (PSRT), Independent Data Monitoring Committee (IDMC) as applicable
- Functioning as a core member of the safety management team in determining if new safety information requires amendment to Investigatorโs Brochures (IB), Informed Consent Forms (ICF), Clinical Trial Plans (CTP) and/or other documentation
- Providing project status reports or summaries on medical and pharmacovigilance trial activities to the Head of Pharmacovigilance
Write/Review Appropriate Sections of:
Protocols
Clinical study reports
Safety update reports
Publications
Other documents in accordance with contractual requirements such as medical review of Informed Consent Documents.
Knowledge, Skills and Abilities:
Excellent judgment and decision-making skills.
Effective time management skills.
Effective oral and written communication skills.
Able to communicate in English, effectively and accurately, both orally and in writing.
Uncompromising attention to detail and the ability to think analytically.
Excellent interpersonal skills and problem-solving ability.
Diplomatic conflict management.
Effective organizational and negotiation skills.
Strong computer skills, including advanced spread sheet skills, and the ability to learn appropriate software as necessary.
Proficient knowledge of therapeutic areas.
Medical writing skills.
Ability to prioritize workload.
Ability to work independently and unsupervised.
Knowledge of all relevant and current clinical medical policies, directives, rules, regulations and clinical performance standards of medical ethics and legal requirements of accrediting bodies.
Expert knowledge of all SOPs, ICH GCP, SA GCP and local legal requirements, European, FDA and other relevant international guidelines applicable to clinical research.
Position Requirements:
Education: MBChB
Preferred Job-Related Experience: A minimum of three years in a clinical research setting
Physical Expectations:
Typical office environment.
Ability to sit or stand for extended periods of time.
Ability to move 5-15 lbs.
Travel Requirements:
Expected travel time is less than 10 % for this position.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.
FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.
This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.
Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicantsโ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicantโs tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.
FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.
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