Precision for Medicine is not your typical CRO.
The 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 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.
- 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.
- 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.
- 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.
- 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 Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.