We are seeking a highly motivated and detail-oriented Study Start-Up/Feasibility Representative to join our Clinical Operations team. The ideal candidate will have a bachelor's degree and/or a minimum of 3 years of independent study start-up/feasibility experience. This role involves coordinating and managing the start-up phase of clinical trials, including site selection, feasibility assessments, and regulatory submissions.
What you’ll do:
- Conduct thorough feasibility assessments to evaluate the suitability of sites for clinical trials.
- Collaborate with site investigators and study teams to gather necessary information and assess site capabilities.
- Identify and recommend (in collaboration with CTM, and ClinOps Director(s) potential study sites based on feasibility assessments and strategic alignment with study goals.
- Perform Investigator Due diligence check in accordance with company SOP, and/or Clinical operations processes
- Establish and maintain relationships with site investigators and study coordinators.
- Prepare and submit regulatory documents required for study start-up, including IRB/EC submissions and regulatory agency applications.
- Ensure compliance with all applicable regulations and guidelines.
- In collaboration with the Sponsor Oversight managers (SOM), coordinate site initiation visits and ensure all required documentation and contracts are in place before study start.
- Work closely with clinical operations, regulatory affairs, and other departments to ensure smooth study start-up processes.
- Maintain accurate and up-to-date records of all study start-up activities.
- Provide regular updates and reports to management on the status of study start-up activities.
- Ensure adherence to company SOPs, GCP, and other regulatory requirements.
- Participate in audits and inspections as needed.
About you:
- BA/BS Degree in Business, Life Sciences, Paralegal with a minimum of 3 years of independent study start-up/feasibility experience in clinical research or 10 + years of direct experience
- Strong understanding of clinical trial processes, regulations, and guidelines.
- Excellent organizational and project management skills.
- Ability to work independently and manage multiple projects simultaneously.
- Strong communication and interpersonal skills.
- Proficiency in MS Office Suite and clinical trial management systems (CTMS).
$50 - $70 an hourThis is a contract hourly position (6mo contract to start).
About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.At Adverum, Inclusion and Diversity are at our core.
We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientationApply for this job
