Job description

Job Summary:

The Clinical Research Assistant is primarily responsible for coordinating research patient visits, and study protocols.

Physical Qualifications:

Requires prolonged sitting with some standing, some bending, stooping and stretching, hand-eye coordination and manual dexterity to operate keyboard, photocopies, telephone, office equipment, pertinent clinical machines and perform clinical patient tasks. Requires normal range of eye sight, hearing and aptitude to record, prepare, and communicate appropriate information, charting, and reports.

Performance Requirements:

Knowledge of basic policies and procedures or functions of a multi-physician practice. Knowledge of HIPAA, Compliance, and OSHA regulations related to an outpatient practice. Knowledge of EMR and clinical computer programs and applications. Skill in exercising a high degree of initiative, judgement, discretion, and decision-making to optimally achieve the goals of the position. Skill in establishing and maintaining effective working relationships with co-workers, physicians, leadership staff, patients, and the public. Ability to have knowledge of, organize and prioritize work effectively to meet the set goals, deadlines and objectives of the position. This includes maximizing patient flow, charting and coding appropriately, and being able to perform tests and procedures required for study purposes. Ability to communicate clearly and effectively both in writing and verbally.

Job Qualifications

1. High School Diploma or equivalent

2. Previous experience in a medical group practice preferred.

3. Two years in Clinical Research in Ophthalmology experience preferred.

4. Knowledge and experience in clinical trials required.

Certificate/License

Certified Ophthalmic Technician or Certified Ophthalmic Assistant preferred.

Certified Patient Service Specialist (CPSS), obtained within 6 months of hire date.

Performance Expectations

Must maintain excellent organizational skills and attention to detail.

Self-motivated, takes initiative, has ability to prioritize and can multi-task.

Facilitates and coordinates daily clinical trial activities. Coordinates patient visits.

Review all study protocols, confidentiality ad privacy protections.

Screens candidates for eligibility using protocol specific inclusion and exclusion criteria.

Conducts and/or participates in the informed consent process with research participants. Obtains appropriated signatures and dates on forms in appropriate places per the research SOP.

Registers each participant in the electronic data capture to ensure billing of study procedures to the appropriate funding source.

Collects data required by the protocol. Assures timely completion of Case Report Forms.

Maintains adequate inventory of study supplies. Follows the sponsor protocol on Investigative Drug/Device Accountability.

Creates source documents for data capture per study protocol and manual of procedures

Organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.

Responsible for documenting date of training and signatures of study staff on study specific training log.

Maintain CV’s and training materials per protocol.

Coordinates monitor site visits and assists with preparation of site visit documentation.

Collect documents needed to initiate the study for sponsor submission.

Attend teleconferences and Investigator meetings.

Works with members of the clinic to recruit eligible candidates to meet enrollment goals. Has excellent teamwork attitude.

Utilizes patient chart on an as needed basis, accessing only information related to treatment, payment, and health operations.

Maintains and adheres to company’s HIPAA, Compliance, and OSHA policies.

Other duties as assigned.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person

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