Clinical Research Coordinator/Assistant in Bakersfield, California at Empire Eye and Laser Center Inc

COME JOIN OUR TEAM

At Empire Eye and Laser Center, we look for the highest quality people to work together to deliver the highest quality patient service.

Benefits for full time employees include:

• Health insurance
• Dental insurance
• Vision insurance
• Supplemental Insurance Plans
• 401(k) with matching
• Flexible spending account
• Paid time off
• Company Perks

Position Summary

Under the direct supervision of the Clinical Research Manager, the Clinical Research Coordinator / Assistant supports daily clinical research operations through study coordination, administrative support, patient care, and technical and clinical testing responsibilities. This position plays an integral role in coordinating and conducting ophthalmic clinical research studies, including participant recruitment and enrollment, study visits, data collection, ophthalmic diagnostic testing, imaging procedures, and operation of specialized clinical testing equipment. The position works collaboratively with investigators, research personnel, clinical staff, and sponsors to conduct studies efficiently and in compliance with protocols, regulatory requirements, and organizational standards. Responsibilities may include both direct participant-facing activities and hands-on clinical testing and technical support, with assignments varying based on training, qualifications, delegated authority, and departmental needs.

Essential Functions

An individual must be able to perform each essential function satisfactorily, with or without reasonable accommodation. The requirements described below are representative, but not all-inclusive, of the knowledge, skills, abilities, and responsibilities required.

Qualifications

High school diploma or GED equivalent required.

Associate degree in Biology or related field, or two (2) years of related work experience, preferred.

Bachelor’s degree in Biology or related field, or four (4) years of related work experience, preferred for advanced coordination responsibilities.

ACRP or SOCRA clinical research certification preferred; JCAHPO certification preferred.

Previous medical, ophthalmic, or clinical research experience and EMR experience preferred.

Knowledge / Skills / Abilities / Talents

Understanding of GCP, HIPAA, and federal, state, and institutional clinical research requirements.

Knowledge of patient screening/pretesting, ophthalmic assessments, and IOL calculations preferred.

Ability to use computer applications and secure research databases; typing proficiency of at least 40 WPM with accuracy.

Excellent organization, attention to detail, task prioritization, time management, and written and verbal communication skills.

Ability to maintain confidentiality, work independently, adapt to changing priorities, and contribute to a collaborative team.

Bilingual in English and Spanish preferred.

Shared Accountability & Delegation

Research team members share operational responsibilities and support cross-coverage while remaining accountable for individually assigned work. The Clinical Research Manager designates primary study assignments, task distribution, and priorities based on study complexity, department needs, qualifications, and documented training. Activities requiring specific authorization, investigator delegation, or physician approval may only be performed by appropriately qualified personnel. Principal Investigators retain applicable medical and regulatory oversight of clinical studies.

Physical Demands

Regularly required to sit, stand, walk, speak, and hear.

Requires sufficient hand dexterity to operate a keyboard, perform assigned clinical tasks, and read a computer screen.

May occasionally lift and/or move up to 20 pounds.

Reports to

• Clinical Research Manager

Classification

• Full time, non-exempt

Compensation

• $23-28, depending on experience

Empire Eye and Laser Center is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.

Applicants will be required to pass a post offer background check.

Responsibilities

Clinical Research Coordination & Participant Management

Coordinate daily activities for assigned studies, including study start-up, maintenance, and closeout.

Recruit, prescreen, screen, and enroll potential study participants; verify protocol inclusion and exclusion criteria.

Facilitate and document informed consent and coordinate participant randomization when trained, authorized, and delegated.

Schedule and coordinate participant visits, testing, procedures, and follow-up within required protocol windows.

Prepare charts, study materials, and visit documentation; perform assigned study-specific testing within demonstrated competency.

Maintain accurate screening, enrollment, visit, and follow-up logs; meet sponsor and protocol timelines.

Contact participants regarding recruitment, appointments, study requirements, and follow-up needs.

Documentation & Regulatory Compliance

Comply with Good Clinical Practice (GCP), HIPAA, approved protocols, and applicable federal, state, and institutional requirements.

Prepare, organize, and maintain regulatory binders, site files, source documents, case report forms, and study logs.

Collect, review, and accurately enter study data into designated secure research databases within required timelines.

Assist with Institutional Review Board (IRB) submissions, amendments, continuing reviews, and correspondence as assigned.

Identify, document, and promptly communicate adverse events, serious adverse events, protocol deviations, and product complaints according to applicable reporting requirements.

Schedule and facilitate site monitoring visits; assist with preparation, audit readiness, data queries, follow-up, and closeout.

Participate in study trainings and investigator meetings; maintain files according to sponsor and retention requirements.

Clinical, Surgical & Investigational Product Support

Perform assigned patient triage, screening, pretesting, ophthalmic assessments, and protocol-specific testing within training and competency.

Assist with review of preoperative cataract measurements and supplemental reports

Prepare surgical orders for review and finalization by the Medical Director or designated surgeon; maintain related surgical logs.

Assist with receipt, storage, handling, authorized dispensing, return, and accountability of investigational products and devices under study protocols and delegated authority.

Maintain investigational product inventory and accountability records; scan and upload surgical and study charts into the EMR.

Administrative & Collaborative Department Support

Maintain the clinical research calendar and appointment records; review scheduled visits, provide weekly participant schedules to study staff, and promptly report changes.

Make recruiting calls and answer the general research telephone line; organize study materials, files, and departmental tracking tools.

Communicate proactively with investigators, sponsors, participants, research staff, and clinical colleagues about study status, deadlines, and outstanding tasks.

Assist coworkers during absences and high-volume periods; maintain accurate task handoffs and cross-train for continuity across active studies.

Attend department meetings, support process improvements, and perform additional related duties assigned by the Clinical Research Manager consistent with training and authorization.