Associate Director, Study Start Up

Codera

Associate Director managing study start-up and records management for clinical trials at Codera. Supporting clinical operations and compliance in drug development processes.

Posted 5/5/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $160,000 - $230,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support the execution of Phase I-IV studies including study start-up, site management and clinical operations activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s) and applicable study plans.
Prepare and manage potential Investigator site lists, perform site outreach, assist in identifying clinical trial sites and contribute to site feasibility and site selection decisions.
Act as main contact for study sites during start-up, including communicating with investigators and site staff on issues related to feasibility, essential document collection and IRB submissions.
Support study start-up activities including the review of feasibility questionnaires, facilitation of site selection internal approvals, review of and facilitation of ICF internal approvals, and the completion of Investigator background checks.
Prepare and review study documents (e.g., essential document packets, study plans, site Informed Consent Forms (ICFs), etc.) to ensure quality and consistency.
Distribute and follow-up on start-up documents with sites.
Review returned documents from the sites to ensure quality and completeness.
Review and approve Essential Document Packages for site activation.
Responsible for oversight of the central IRB in the United States/Canada.
Prepare and submit required study documents to central IRB.
Support central IRB annual reviews and study updates.
Communicate with central IRB as needed.
Support site IRB annual reports and updates, as needed.
Assist with the facilitation of the site contract and budget process.
Manage translation of necessary documents through translation vendor.
Support creation of and updates to study translation plan.
Support setup and management of Clinical Operations vendors (e.g. rater training, home healthcare). Facilitate and track vendor system access requests.
Assist in Clinical Trial Management System (CTMS) maintenance including entry of study and site level updates, assistance with running reports and reviewing CTMS entry accuracy.
Review study documents received from the study team for completeness and accuracy and upload to the Trial Master File (TMF).
Assist with TMF quality reviews to ensure completeness, accuracy and timeliness of study documents to ensure TMFs are inspection ready at all times.
Assist with oversight of study site training.
Support inspection preparedness and study/site audit and/or inspection activities, as needed.
Execute other duties as assigned.

Requirements

What you’ll need

Bachelor’s Degree with minimum 5 years of relevant clinical trial experience required
Minimum 3 years of feasibility and study start-up experience
Experience and proven proficiency in CTMS and eTMF systems
Experience with Veeva Systems preferred
General knowledge of clinical site monitoring, feasibility and study start-up preferred
Detail-oriented, organized, and committed to quality and consistency
Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
Excellent team-interaction skills and ability to work successfully in global team settings
Ability to work in a dynamic environment with a high degree of flexibility
Possess a willingness and ability to work hands-on and with a sense of urgency in a fast-paced, entrepreneurial environment
Must be proficient in Microsoft Word, Excel, and PowerPoint.

Benefits

Comp & perks

employer sponsored insurance plans including medical, dental and vision coverage
generous paid time off
retirement plan options
additional wellness and professional development programs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial experiencefeasibility experiencestudy start-up experienceCTMS proficiencyeTMF proficiencysite monitoringdocument reviewIRB submissionsinvestigator background checksquality reviews

Soft Skills

detail-orientedorganizedresults-driventeam-interaction skillsflexibilitysense of urgencycommitment to qualityability to manage competing assignmentscommunication skillsability to work in dynamic environments