Company Overview:
HGI Clinical is a clinical research organization committed to advancing healthcare by conducting clinical trials across various therapeutic areas. We are dedicated to delivering innovative solutions and high-quality data to support the development of life-saving treatments. We are looking for a highly motivated and experienced Associate Director to join our team and lead efforts in Study Start-Up and Clinical Records.
Position Summary:
The Associate Director of Study Start-Up and Clinical Records will be responsible for overseeing the efficient and timely initiation of clinical studies while ensuring compliance with regulatory requirements, company SOPs, and industry standards. This role will also involve managing clinical trial documentation and records management, ensuring that all clinical documentation is appropriately archived and maintained throughout the life cycle of the study. This role may be remote.
Key Responsibilities:
- Lead and oversee all activities related to Study Start-Up (SSU), including essential document preparation and ethics submissions.
- Collaborate with internal and external stakeholders to develop and execute detailed project plans for Study Start-Up, ensuring timelines and deliverables are met.
- Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
- Oversee the preparation and maintenance of clinical trial master files (TMF) and ensure accurate and timely documentation for all clinical trials.
- Manage and track clinical trial documents, including regulatory submissions, site agreements, and informed consent forms.
- Provide guidance and leadership to the Study Start-Up and Clinical Records team, ensuring optimal performance and professional development.
- Act as the primary point of contact for clinical trial records management, ensuring proper organization, version control, and storage of clinical study materials.
- Prepare study team project reports and updates regarding the status of essential document collection, review, and approval
- Support audits and inspections related to clinical trial documentation and regulatory compliance.
- Develop and implement process improvements to streamline Study Start-Up and Clinical Records management.
- Assist in preparation of new business proposals and present during bid defenses, and general capabilities meetings.
- Other tasks as needed.
Qualifications:
- Bachelor’s degree in Life Sciences or related field.
- Minimum of 5 years of experience in clinical research, with a focus on Study Start-Up, clinical trial documentation, and records management.
- Strong knowledge of clinical trial regulations, GCP, ICH guidelines, and regulatory compliance.
- Experience managing or leading teams, including providing mentorship and development opportunities for staff.
- Proven track record of successful study start-up, site activation, and clinical records management in a global clinical trial environment.
- Excellent organizational, problem-solving, and communication skills.
- Ability to work independently and collaboratively in a fast-paced, dynamic environment.
- Experience with clinical trial management systems (CTMS), electronic Trial Master File (eTMF), and other clinical data management tools.
- Familiarity with vendor management and negotiation.
Preferred Qualifications:
- Experience working in a small CRO environment.
- Experience with TMF Administration. Florence experience ideal.
- Knowledge of eClinical technologies and platforms for document management and trial tracking.
- Prefer remote based in Texas or North Carolina.
How to Apply:
Please submit your resume and cover letter detailing your experience and qualifications to [email protected].