Clinical Research Internship

Job Overview: The Clinical Research Intern is a multifaceted role designed to provide hands-on experience in clinical research, laboratory operations, and surgical skills labs in an orthopedic setting. This position offers opportunities to develop technical and professional skills while contributing to cutting-edge research and patient care. The assistant will support clinical trials, laboratory studies, and surgical training programs, ensuring compliance with regulatory standards and enhancing operational efficiency.

Key Responsibilities:

Clinical Research Support

Assist Clinical Research Coordinators (CRCs) in patient visits, informed consent processes, and scheduling.

Collect and document patient data, including adverse events, concomitant medications, and administering questionnaires.

Enter data into electronic data capture systems, ensuring accuracy and compliance with study protocols.

Perform literature searches for project development and manuscript preparation.

Support the maintenance of critical laboratory equipment and sample analysis.

Interact professionally with research participants, maintaining privacy and adhering to HIPAA and IRB regulations.

Laboratory Operations

Assist with ongoing research projects in a regulated environment, maintaining compliance with Good Clinical Practices (GCP) and USP 797 standards.

Gain proficiency in laboratory techniques, including Stem Cell Cryopreservation, Stem Cell Culture, Flow Cytometry, Multiplex (ELISA), and Fluorescent Inverted Microscopy.

Support the cleanroom’s upkeep and compliance standards.

Process and manage laboratory inventory, including supplies and reagents.

Enhance and follow standard operating procedures to ensure efficient lab operations.

Surgical Skills Lab Support

Participate in surgical skills lab setup, execution, and cleanup for arthroscopic and open procedures.

Prepare cadaver tissue for use in the lab, adhering to strict handling and storage guidelines.

Assist in hosting surgical skills labs, collaborating with orthopedic surgeons and medical representatives.

Ensure compliance with OSHA, HIPAA, and other regulatory standards.

Develop and refine operational procedures for the surgical skills lab.

General Responsibilities

Gain experience in a professional healthcare and research setting.

Enhance skills in Microsoft Excel, Word, and PowerPoint for documentation and reporting.

Support project management tasks, including tracking milestones and maintaining timelines.

Engage with cross-functional teams to facilitate research and educational goals.

Learning Objectives:

Research Learning Objectives

Understand clinical research processes and documentation requirements in an orthopedic setting.

Acquire skills in overseeing informed consent and navigating electronic data capture systems.

Gain experience in patient care and interaction within HIPAA-compliant practices.

Develop proficiency in Microsoft Office tools for research-related tasks.

Laboratory Learning Objectives

Perform research in an FDA-regulated environment and maintain cleanroom compliance.

Gain foundational knowledge in advanced laboratory techniques such as Stem Cell Cryopreservation and Flow Cytometry.

Assist in ongoing research projects and adhere to Good Clinical Practices (GCP).

Surgical Skills Lab Learning Objectives

Obtain hands-on experience in a surgical skills lab, assisting in arthroscopic and open procedure labs.

Learn to manage lab operations, including cadaver tissue handling and regulatory compliance.

Enhance organizational skills in hosting surgical events.

Qualifications:

Obtaining or completion of a Bachelor’s degree in a related field (e.g., Biology, Chemistry, Health Sciences) or equivalent experience.

Strong interest in clinical research, laboratory science, and orthopedic medicine.

Familiarity with Microsoft Excel, Word, and PowerPoint.

Excellent communication and organizational skills.

Ability to handle sensitive information with discretion and professionalism.

Willingness to learn and adapt in a dynamic environment.

Preferred Qualifications:

Previous experience in a research or healthcare setting.

Knowledge of Good Clinical Practices (GCP) and FDA regulations.

Basic laboratory skills and understanding of laboratory safety protocols.

Working Conditions:

Exposure to clinical, laboratory, and surgical environments.

May require handling of biological specimens, including cadaver tissue.

Regular interaction with healthcare professionals, researchers, and study participants.

Must adhere to strict safety and regulatory standards.

Internship Employment Type: Full-Time/Part-Time