RESEARCH ASSISTANTAt — MEMORIAL RESEARCH MEDICAL CLINIC

The Research Assistant at Orange County Research Center (OCRC) supports the conduct of Phase I-IV clinical research studies under the supervision of experienced Clinical Research Coordinators, investigators, and department leadership. The student will gain hands-on exposure to the operational, clinical, regulatory, and documentation requirements involved in conducting pharmaceutical and biotechnology-sponsored clinical trials.

Responsibilities include assisting with participant visits, preparing study-specific materials, collecting and documenting protocol-required information, performing clinical research procedures for which the student has been trained and deemed competent, assisting with laboratory sample processing and study documentation, maintaining accurate source documentation, and supporting study teams in accordance with the research protocol, Good Clinical Practice (GCP), OCRC procedures, and applicable regulatory requirements.

The Research Assistant does not independently make medical or eligibility determinations and performs assigned activities under appropriate supervision and within the scope of his or her documented training and competency.

Tasks:

The Research Assistant's duties are designed to provide meaningful exposure to the professional conduct of clinical research. More than 80% of assigned responsibilities will consist of professional or pre-professional clinical research activities.

The student may perform the following duties under appropriate supervision:

Review study protocols, visit schedules, laboratory manuals, and study-specific instructions relevant to assigned responsibilities.
Prepare materials and documentation needed for scheduled clinical research participant visits.
Assist Clinical Research Coordinators and investigators during screening, enrollment, treatment, follow-up, and other protocol-required visits.
Assist with collection and documentation of participant medical and study-related information as directed by the study team.
Perform trained clinical procedures such as vital signs, height, weight, ECGs, and other protocol-required assessments.
Assist with the informed consent process as permitted by site policy and only after appropriate training and delegation; the investigator or appropriately qualified study staff retain responsibility for ensuring informed consent requirements are met.
Complete study source documentation accurately and contemporaneously using Good Documentation Practices.
Review study records for completeness and bring missing, inconsistent, or potentially noncompliant information to the attention of the supervising coordinator.
Assist with laboratory sample collection activities as appropriate to training and assigned responsibilities.
Process blood, urine, or other clinical research specimens according to protocol and laboratory manual requirements when appropriately trained.
Centrifuge, aliquot, label, store, and prepare samples for shipment according to study requirements.
Assist with laboratory kit preparation, sample manifests, shipment documentation, and specimen tracking.
Assist with maintaining required study supplies and identifying study-specific material needs.
Enter or assist with entry of study-related information into approved electronic systems under supervision.
Assist with resolution of study documentation questions or data queries by locating and reviewing supporting source documentation.
Participate in study team meetings, study kick-off meetings, training sessions, and operational discussions when appropriate.
Observe and learn interactions among research sites, pharmaceutical sponsors, Contract Research Organizations, monitors, laboratories, Institutional Review Boards, and other clinical research partners.
Assist with preparation for sponsor monitoring visits, internal quality reviews, and study file review activities.
Follow OCRC Standard Operating Procedures, study protocols, Good Clinical Practice requirements, safety policies, privacy requirements, and sponsor instructions.
Communicate questions, concerns, potential protocol deviations, safety issues, or documentation discrepancies to the supervising Clinical Research Coordinator or investigator.
Maintain participant confidentiality and professional standards at all times.
Perform limited administrative or organizational tasks when directly related to supporting clinical research activities; such duties will represent a minority of the internship experience.

Through these activities, the student will gain practical experience in the conduct of regulated clinical research and develop transferable skills applicable to careers in clinical research, medicine, nursing, pharmacy, public health, biotechnology, pharmaceutical development, and related healthcare fields.

Training:

OCRC will provide structured training and ongoing supervision appropriate to the student's assigned responsibilities.

Initial Orientation

At the beginning of the internship, the student will receive orientation covering:

OCRC organizational structure and clinical research operations.
Workplace expectations and professional conduct.
Participant confidentiality and privacy requirements.
Good Clinical Practice and human subject protection principles.
Good Documentation Practices.
OCRC safety procedures, emergency procedures, and applicable occupational safety requirements.
Bloodborne pathogen and laboratory safety requirements, when applicable to assigned duties.
Study-specific protocol and procedure training.
Source documentation expectations.
Applicable electronic systems and study platforms.
Department-specific workflows and escalation procedures.

Task-Specific Training

Before independently performing any assigned research procedure, the student will receive appropriate instruction, observation, supervised practice, and competency verification when required. Training may include:

Vital signs.
ECG collection.
Height, weight, and other clinical measurements.
Study visit preparation.
Source documentation.
Laboratory specimen handling and processing.
Centrifuge and other laboratory equipment use.
Sample labeling, storage, manifest preparation, and shipment procedures.
Clinical research electronic systems.
Study-specific procedures and sponsor requirements.

Students will only perform activities for which they have received appropriate training and authorization.

Learning Outcomes:

By the end of the internship, the student will be able to:

Explain the basic structure and lifecycle of a clinical research study, including screening, enrollment, study visits, follow-up, and study closeout activities.
Demonstrate an understanding of Good Clinical Practice (GCP), participant protection, confidentiality, and the importance of protocol compliance in clinical research.
Review a clinical trial protocol and identify study-specific procedures, visit requirements, timelines, and documentation expectations relevant to assigned responsibilities.
Accurately complete and maintain clinical research source documentation in accordance with Good Documentation Practices.
Assist with the preparation and conduct of participant study visits under the direction of a Clinical Research Coordinator and investigator.
Perform trained clinical procedures such as vital signs, height and weight measurements, ECGs, and other protocol-required assessments within the student's documented competency.
Demonstrate appropriate interaction with clinical research participants while maintaining professionalism, privacy, and confidentiality.
Assist with collection, processing, labeling, handling, storage, and shipment preparation of biological specimens according to study-specific laboratory manuals and site procedures when assigned and appropriately trained.
Recognize the importance of accurate specimen handling, protocol-required time points, sample integrity, and chain of custody in clinical trials.
Identify potential documentation errors, missing information, or protocol discrepancies and appropriately escalate them to the supervising coordinator or investigator.
Demonstrate familiarity with clinical research terminology, essential study documents, source records, electronic data systems, and sponsor/CRO study requirements.
Work effectively as part of a multidisciplinary clinical research team that may include investigators, coordinators, research assistants, laboratory personnel, pharmacists, regulatory staff, quality staff, and recruitment personnel.
Demonstrate professional workplace skills including communication, organization, prioritization, accountability, time management, and attention to detail