Clinical Research Coordinator

Position Summary:

The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of the Clinical Research Manager, the Principal Investigator, and the Medical Director. The CRC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CRC will perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study-specific protocols.

Duties and Responsibilities:

• Administratively and clinically manage an average of four to five clinical trials

• Adhere to research SOPs

• Adhere to Good Clinical Practices and study protocols

• Ensure the scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials

• Discuss study protocols with patients and verify the information consent documentation

• Provide patient with written communication of their participation (i.e. copy of the signed informed consent)

• Ensure the patient’s referring physician receives the notification of the patient’s participation in studies as requested by the patient

• Meet with the patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study

• Dispense study medication in a professional and accountable manner following protocol requirements

• Collect, process, and ship blood/urine specimens at scheduled patient visits Perform ECGs and obtain vital signs of patients

• Schedule all patient research visits and procedures consistent with the protocol requirements

• Complete and maintain case report forms per FDA guidelines and review them against the patient’s medical record for completeness and accuracy

• Administer questionnaires/diaries per protocol

• Ensure that non-serious and serious adverse events are properly documented and reported

• Screen laboratory results when received and follow protocol procedure regarding abnormal results

• Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder

• Submit patient reimbursement requests at the conclusion of patient’s participation in the protocol

• Ensure the filing and maintenance of all regulatory documents

• Schedule monitor visits and set up for monitoring visits before the monitor’s arrival

• Participate in site assessments, pre-trial assessments, site initiation, subject recruitment and retention, monitoring, and close-out of clinical activities

• Other duties as assigned

Education & Experience

• Minimum associate degree in a health-related field

• Minimum of two years of experience with clinical trial management

Qualifications & Requirements

• Able to read, analyze, and interpret information from professional journals, technical procedures, or governmental regulations

• Able to effectively present information and respond to questions from physicians, staff, and patients

• Knowledge of Good Clinical Practices and the regulations necessary for the protection of human subjects and the conduct of clinical research required.

• Knowledge of EHR systems

• Able to function effectively in a team setting

• Needs to demonstrate consistent professional conduct and meticulous attention to detail

• Must possess excellent verbal and written communication skills as well as excellent interpersonal skills with patients, staff, and other health care professionals

• Required to sit for CCRC after two years’ experience

• Travel to any of the other West Coast Retina locations may be necessary upon request.

• Travel within the USA for 2-3-day trips may be required for education conferences and networking events

Job Type: Full-time

Pay: $25.00 - $50.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Retirement plan
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• Clinical Trials Coordination: 3 years (Required)

Location:

• San Francisco, CA 94109 (Preferred)

Ability to Commute:

• San Francisco, CA 94109 (Required)

Work Location: In person