Responsibilities may include the following, and other duties may be assigned.
- Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.
- Develops and maintains liaison with clinical investigators, clinical research organizations (CRO), affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices' approval.
- Responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports.
- May assist with design, development, and monitoring of clinical evaluation projects.
- Trains investigators and site personnel. Includes headquarter and field clinical research associates (CRA).
- Implements and prepares the clinical development strategy as outlined by the clinical teams.
- May contact and recommend qualified investigators to perform studies and initiate clinical trials.
- Ensures recruitment and retention of patients.
SPECIALIST CAREER STREAM:
- Typically, an individual contributor with responsibility in a professional discipline or speciality.
- Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
- May act as a mentor to colleagues or may direct the work of other lower-level professionals.
- Most of the time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
DIFFERENTIATING FACTORS Autonomy:
- Established and productive individual contributor.
- Works independently with general supervision on larger, moderately complex projects / assignments.
- Sets objectives for own job area to meet the objectives of projects and assignments.
- Contributes to the completion of project milestones.
- May have some involvement in cross-functional assignments.
Innovation and Complexity:
- Problems and issues faced are general and may require understanding of a broader set of issues or other job areas, but typically are not complex.
- Adjusts or recommends enhancements in systems and processes to solve issues or improve effectiveness of job area.
Communication and Influence:
- Communicates primarily and frequently with internal contacts.
- External interactions are less complex or problem-solving in nature.
- Contacts others to share information, status, needs and issues to inform, gain input, and support decision-making.
Leadership and Talent Management:
- May provide guidance and assistance to entry-level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience:
- Requires practical knowledge and demonstrated competence within a job area, typically obtained through advanced education combined with experience.
- Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Please contact Fandi Hatib on 01727 817600 or email firstname.lastname@example.org