Study Start Up Specialist
Must Haves: Must have previous experience with Clinical Research and experience with study start up, feasibility, and budget & contract experience
Hours: 40 hours per week, Monday-Friday 9am-5pm. 3-4 days onsite
Contract Duration: contract-to-hire
Benefits: Medical, Dental, Vision, time off, paid holidays off, etc.
Job Overview:
The company seeks a highly motivated and detail-oriented Clinical Research Study Start-Up Specialist to join our dynamic team. The ideal candidate will be responsible for managing and overseeing the start-up phase of clinical trials, ensuring that all required regulatory, site, and logistical components are completed in a timely and efficient manner. This role requires strong organizational skills, a deep understanding of clinical trial processes, and the ability to collaborate with cross-functional teams to ensure smooth and successful study initiation. Works with minimal supervision. This role will be the main contact for all trial start-up activities, across multiple departments, including but not limited to preparation for monitoring visits, and regulatory and/or IRB document preparation. Ensuring all study procedures are conducted according to the protocol and applicable regulations. Trains research staff, supervises staff and oversees clinical trials from start-up to closeout. Develops and/or contributes to standard operating procedures and processes. Attends and engages in leadership meetings, represents the company internally and externally, oversees research operation in a division or department and provides expert consulting at an institutional level.
Key Responsibilities:
Study Start-Up Coordination:
- Lead and coordinate all activities related to the start-up phase of clinical trials, including but not limited to: feasibility, site selection, regulatory submissions, committee approvals, and site training.
- Ensure that all documentation is accurate, complete, and compliant with regulatory requirements, including but not limited to: IRB submissions, informed consent forms, and investigational product documentation.
- Works to identify and problem-solve potential roadblocks to success.
- Oversees and participates in the build of study workflows and timelines.
- Regulatory and Compliance:
- Oversee and participates in the preparation and submission of regulatory documents, including but not limited to: approvals, applications, investigator brochures, and other essential regulatory submissions to the necessary authorities and committees.
- Collaborate with internal and external stakeholders (e.g., sponsors, CROs, PIs, IRBs, approval committees) to ensure all approvals are obtained in a timely manner.
Site Management:
- Work closely with site personnel to ensure the timely initiation of clinical study sites, including contracting, budget negotiation, and site feasibility assessments.
- Trains and supervises research staff on the proper procedures for conducting a clinical trial per GCP.
- Reviews effort reports of site personnel and analyzes start-up processes for accuracy and efficiency.
- Performs regular quality control assessments to ensure that clinical trial data is collected and stored per GCP and JCRP standards
- Designs or assists in design of electronic capture databases, if appropriate, and manages all the data collected.
- May provide clerical and technical support to ensure adherence to research protocols and quality of information received.
Minimum Qualifications:
- Bachelor's degree and 5 years of clinical research experience or master's degree and 3-year clinical research experience.
- Must have previous experience with Clinical Research and experience with study start up, feasibility, and budget & contract experience
Apply Today.