Study Start-up Specialist Job

STUDY START-UP SPECIALIST needed for a contract job opportunity with Yoh's client located in South San Francisco, CA.

WHAT YOU'LL BE DOING:

- Coordinates, guides and assists with all start up activities prior to site activation, including but not limited to:
- Site Informed Consent Form (ICF) localization and guidance in line with regulatory/health authority requirements Ethics Committee information, meeting dates & costs Ethics applications & associated online systems Ethics & Governance submission processes Clinical Trial Health Authority application and regulatory submission process Contracts & Indemnity request process Localize global Informed Consent Form (ICF) with country requirements Other materials and documentation used by the study requiring local governance approval
- Maintains up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation
- Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation
- Ensures all start up information & requirements are kept up to date in a central repository for project teams
- Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial processes, government policies/laws, via innovative approaches
- Maintains up-to-date understanding of Start Up processes by liaising with key stakeholders, and looks for emerging trends across government, hospital, industry and other stakeholders to evolve the unit and to resolve any issues
- Proactively responds to information survey requests by government, health regulatory authorities and industry bodies
- Provides continuous and proactive communication with ECs/hospital administration/industry bodies to obtain accurate and up to date information on clinical trial status and activities Maintains communication with local legal/regulatory/medical affairs departments to ensure input is sought and all internal/external requirements are met
- Provides guidance to CSMs on regulatory/ethics, track & drive site activations by regular review and monitoring status of submissions/activations
- In collaboration with vendor management and procurement, provide input as required into vendor identification, selection, and RFI/RFP process.
- Liaises and shares best practices with other SSUs within CCO
- Provides expertise and guidance to Local Study Team (LST) for identification, creation and implementation of specific recruitment/retention tactics & contingency planning Initiates patient recruitment meetings with CSM and advise on study-specific recruitment & retention needs
- Develops innovative patient recruitment/retention practices and share concepts with vendors as needed

WHAT YOU NEED TO BRING TO THE TABLE:

- Prior work experience demonstrating knowledge and understanding of clinical trials, such as that obtained in a clinical trial monitor capacity, and experience managing projects.
- Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country
- Excellent communications skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution
- Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken form.
- Experience working as part of a team with a proven ability to make an active contribution to the team's performance and teamwork
- Able to make effective decisions, self-motivated, assertive, and displays initiative
- Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility
- Demonstrated computer literacy, usage of MS Office software, web-based systems and databases
- Availability to travel domestically and internationally if required.
- University Degree or Equivalent preferably in a medical/science-related field

GET HIRED. APPLY NOW!

RECRUITER: Rob West

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

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