Study Start-up Specialist

7 days ago

Sydney, Australia Precision Medicine Group Full time

**Precision for Medicine is not your typical CRO.**

The Senior Study Start Up (SSU) Specialist is a seasoned, experienced professional in country site start-up activities.

Responsibilities will be dependent upon the location of the SSU according to the applicable regulations and processes governing study and site start-up and activation. Typically, these include activities such as Informed Consent Form review and adaptation, Regulatory Document collection and quality review, Support to Regulatory and sites on IRB/EC/CA submissions and support to Site Contracts group in budget and contract negotiation.

The Sr. SSU acts as Subject Matter Experts for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities, trainer for non-experienced staff on site start-up activities as well as owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

**Essential functions of the job include but are not limited to**:

- Responsible for delivery, in terms of timeliness and quality, of site activation within the assigned country/sites and foreseeing and mitigating any risks.
- Preparation/Support of EC/IRB submissions, collection and review of regulatory documents, notifications to IRB, EC and regulatory authorities, as appropriate.
- Preparation/Support the development of start-up plans and essential document checklists.
- Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
- Review and manage collection of essential documents required for site activation/IMP release.
- Customize country/site specific Patient Information Sheet and Informed Consent Forms.
Responsible/facilitate the translation and co-ordination of translations for documents required for submission.
- Maintain communication with other key functions participating to country start up i.e.,
- Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
- Act as SME for collection and maintenance of local IRB/Ethics Committee (EC), other related organizations, site contracts and budget negotiations and any other start up requirements for assigned country.
- Participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
- If required, support Regulatory group on research of local requirements for documentation of CA submissions, approvals, and subsequent follow-up documentation.
- Participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
- Development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
- Development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
- Mentor staff on local study start-up regulations, submissions, and internal procedures.
- Interacts with client, participates in proposal activities, including development and client presentations as required.
- Performs other duties as assigned by management.

**Minimum Required**:

- Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
- 5 years or more as a SSU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.

**Other Required**:

- Excellent communication and organizational skills are essential.
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
- Fluency in English and for non-English speaking countries the local language of country where position based.

**Preferred**:

- Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country.
- Experience using Study Start-up tracking tools/systems
- Ability to prioritize workload to meet deadlines.
- Can assist junior SSU activate specialists in problem resolution.

**Competencies**
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.
- Strong organizational skills.
- Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located.
- Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.
- Must demonstrate excellent computer skills.
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
- Occasional travel may be required.

Precision Medicine Group is an Equal Opportunit

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