Study Start-Up Associate

Rho Inc

1d•$55,000 - $65,000

About The Position

The Study Start-Up Associate works closely with multidisciplinary project teams throughout the project lifecycle to plan and deliver study start-up activities consistently, on time, and with high quality. The role supports end-to-end coordination of study start-up planning and execution, including investigator assessment and identification, pre-study development, site qualification, and site activation. It requires collaboration with internal and external stakeholders, including clinical study teams, other functional areas, Sponsors, and study sites. The Associate supports site feasibility and identification, regulatory and IRB/IEC submissions and approvals, site essential document and informed consent form processes, and site budget and contract coordination. The role also maintains study systems, trackers, databases, and Trial Master File documentation, monitors site-level progress, and partners with the Study Start-Up Lead to coordinate site handoffs to Clinical Operations.

Requirements

Bachelor’s degree.
At least 1 year of experience in a clinical research setting.
Good knowledge of general clinical research processes and medical terminology.
Basic understanding of regulatory and IRB/IEC submission processes for assigned countries.
Working knowledge of current ICH GCP guidelines and applicable regulations.
Good written and verbal communication skills.
Initiative in completing project responsibilities and seeking guidance as needed.
Good organizational and time-management skills, ability to meet deadlines, and strong attention to detail.
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
Ability to manage multiple competing priorities across clinical trials and work effectively as a team player.

Nice To Haves

Clinical research experience within a CRO is preferred.

Responsibilities

Participate in the start-up process through site activation and provide timely, professional customer service to internal and external parties.
Collaborate with the Feasibility team, CTL, SSUL, Rho Legal, Sponsors, and site staff to obtain site lists and ensure fully executed CDAs are established.
Contribute to trial feasibility by distributing questionnaires and following up with site personnel to obtain complete responses.
Maintain SSU trackers, databases, and shared documentation to track site identification and selection metrics, and file required site-level feasibility documentation in the TMF.
Support the SSU Lead with collecting, preparing, and executing regulatory and IRB/IEC submissions and approval activities, including country-level and local approvals.
Provide administrative support for regulatory and IRB/IEC workflows, such as formatting, quality-control checks, document versioning, and uploading documents to submission platforms.
Maintain accurate regulatory and IRB/IEC documentation in SSU trackers, the TMF, and databases.
Coordinate with sites to obtain site-level regulatory and IRB/IEC submissions and approvals.
Support and, when appropriate, lead the creation, distribution, collection, review, and approval of Site Essential Document packages under the SSU Lead’s guidance.
Support adaptation of site-level Informed Consent Forms, including review, quality-control checklists, negotiation, and approval with relevant parties under SSU Lead oversight.
Track, maintain, and file Site Essential Document documentation in SSU databases, trackers, and the TMF.
Liaise with Rho Legal and sites to facilitate negotiation and execution of site budgets and contracts.
Provide administrative support and maintain timely tracking, database updates, filing, and handling of budget and contract progress and documents.
Assist in collecting site-level information needed to prepare initial budgets and contracts.
Maintain relevant systems and keep them up to date so the SSU Lead can assess progress metrics against study targets and timelines.
Partner with the SSU Lead to determine and execute appropriate site-by-site handoff timing to Clinical Operations.