Contract Research Physician

**Summary of the position**:
**Essential Functions**:

- Contribute to the development and review of protocols and their amendments.
- Answer trial-related medical questions and interact with project team members such as Project Managers, Clinical Operations, Regulatory Affairs and Data Management 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 Pharmacovigilance Associate/Manager, 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, as applicable.
- Serious Adverse Event (SAE) and other safety event medical triage, review, evaluation, and querying.
- Oversight of and support to Pharmacovigilance Associate/Manager 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 study Protocols, Investigator’s 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.
- Perform other duties and responsibilities as may be assigned from time to time.

**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**:MD/MBChB or international equivalent.

**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.; or 2.26 - 6.8 kg.

**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. and its subsidiary and affiliate companies provide 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._