What are the responsibilities and job description for the Sub-Investigator position at SRA Trials?
We are a privately owned and operated clinical research organization. We help volunteers get involved in clinical trials, which allow patients to play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. Our company works with all major pharmaceutical companies and conducts studies in a myriad of therapeutic areas.
We have an immediate opening for a full-time Sub-Investigator.
We have an immediate opening for a full-time Sub-Investigator.
The Sub-Investigator, you will work closely with the Principal Investigator (PI) and other members of the research team to conduct clinical trials and research studies effectively and ethically. Responsibilities include assisting in study design, patient recruitment, data collection, monitoring participant safety, and ensuring compliance with regulatory requirements.
Main Duties and Responsibilities
1. Study Design & Protocol Development
- Collaborate with sponsors, Principal Investigators, and research teams to design and develop clinical study protocols.
- Conduct feasibility assessments and assist in defining study objectives, endpoints, and procedures.
- Prepare and review study-related documents, including protocols, informed consent forms, and case report forms (CRFs).
- Support protocol amendments and ensure alignment with scientific and regulatory requirements.
2. Participant Recruitment, Screening & Enrollment
- Identify, screen, and enroll eligible participants according to study criteria.
- Explain study requirements, procedures, benefits, and risks to potential participants.
- Obtain and document informed consent in compliance with regulatory standards.
- Oversee recruitment strategies and maintain accurate screening and enrollment records.
3. Participant Care & Safety Management
- Monitor participant safety throughout the clinical trial.
- Evaluate, document, and report adverse events and ensure appropriate follow-up actions.
- Provide or coordinate medical care and interventions under study protocols.
- Educate participants regarding study procedures, rights, and responsibilities.
4. Clinical Data Collection & Documentation
- Collect and oversee study data through participant assessments, interviews, examinations, and laboratory testing.
- Ensure accurate, timely, and complete completion of CRFs and study records.
- Maintain the integrity, accuracy, confidentiality, and security of clinical trial data.
- Ensure comprehensive maintenance of study documentation and correspondence.
5. Regulatory Compliance & Quality Assurance
- Ensure compliance with Good Clinical Practice (GCP), FDA regulations, protocol requirements, and institutional policies.
- Prepare, review, and submit regulatory documents, amendments, and required reports.
- Participate in monitoring visits, audits, and inspections.
- Maintain readiness for regulatory review and ensure proper documentation practices.
6. Leadership & Research Team Management
- Provide leadership and oversight throughout all phases of the clinical trial, from initiation through close-out.
- Manage and supervise research personnel, including coordinators, nurses, sub-investigators, and data specialists.
- Train and mentor research staff on study procedures, protocol requirements, and regulatory standards.
- Foster collaboration and accountability across the research team.
7. Stakeholder Communication & Collaboration
- Serve as the primary liaison between sponsors, study teams, regulatory agencies, and other stakeholders.
- Facilitate effective communication regarding study progress, challenges, and outcomes.
- Participate in team meetings and contribute to problem-solving and operational planning.
- Collaborate with multidisciplinary teams to ensure successful study execution.
8. Financial & Operational Management
- Manage study budgets, resources, personnel, and equipment.
- Ensure efficient allocation of resources to support study goals and timelines.
- Support operational planning, study initiation, monitoring, and close-out activities.
Required Skills and Abilities
- RN or NP/APRN Certification
- At least 2 years of experience working independently as Sub Investigator.
- Clinical experience in a relevant specialty.
- Knowledge of clinical research principles, regulations, and guidelines.
- Excellent interpersonal and communication skills.
- Strong attention to detail and organizational skills.
- Ability to work independently and as part of a multidisciplinary team.
- Proficiency in medical terminology and electronic data capture systems.
- Commitment to ethical conduct and participant safety in clinical research.
At our company, we value our employees' contributions and offer a competitive salary package along with benefits such as health insurance, retirement plans, and paid time off. Join our team of dedicated professionals and make a difference in ensuring the quality of our products. Apply today by submitting your resume and cover letter.