Clinical Research Coordinator

Exer Medical Corporation•Pasadena, CA

6h•Onsite

About The Position

Clinical Research Coordinator is the critical role in making clinical research accessible to our patient population while also providing administrative support to the clinic. The Clinical Research Coordinator works on behalf of the Principal Investigator (PI) and manages everything from patient recruitment, eligibility assessment, and all follow-up to the important preparation and gathering of all data and documents for this highly regulated process.

Requirements

High school diploma
1-3 years of clinical research experience required, including knowledge of clinical trials terminology, processes, forms and reporting
Current Medi-Waste Training for: Bloodborne Pathogens for Healthcare, GHS Hazcom, HIPAA, HITECH & Omnibus
Computer skills
Effective use of computerized patient care system
Knowledge of medical terminology
Knowledge of all safety requirements when handling biohazardous specimens or contaminated instruments
Strong interpersonal skills to interact with patients, families, ancillary departments, physicians and co-workers in a courteous and compassionate manner
Strong, courteous and professional verbal skills to effectively convey sensitive information in a courteous manner in person or on the telephone; effective written communication and computer skills for proper charting
Ability to work well under pressure and be quick on your feet
Has a contagious and positive work ethic; models our core values
An effective team player who contributes valuable ideas and feedback and can be counted on to meet commitments
Proficient use of EMR and CTMS systems and ability to effectively use our systems within 2 weeks
Proficient use of Microsoft (e.g. Office, Excel, Word)
Must maintain a clean, healthful and professional appearance at all times and adhere to our uniform guidelines
Center Based: Requires working in a clinical setting. The noise level is moderate and there is a potential for exposure to infectious diseases and blood-borne pathogens as well as erratic/unpredictable patient behavior
The ability to stand and sit for 5 hours at a time, (with some bending and stooping); ability to use manual dexterity in relation to clinical requirements; use hands to finger, key, handle, reach; some bending, kneeling and stooping; ability to bend; and ability to lift and carry up to 50 lbs.
Ability to be punctual and maintain satisfactory attendance record
Ability to work flexible hours, including nights and weekends. Ability to work overtime should business need arise.
This job requires access to confidential and sensitive information, requiring ongoing discretion and secure information management
Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and ability to adjust and focus
Must be able to hear and speak effectively in English (bi-lingual in Spanish a plus)

Nice To Haves

Phlebotomy certificate preferred
Must be able to hear and speak effectively in English (bi-lingual in Spanish a plus)

Responsibilities

Works with PI to meet or exceed study enrollment as per Sponsor’s inclusion/exclusion criteria
Complete feasibility questionnaires based on site information and all regulatory start up packages
Recruits and enrolls patents in a friendly and professional manner, screening for eligibility criteria
Conducts patient visit, collects all required data in appropriate formats, and follows up with all subjects as appropriate
Reports, tracks and follows up on an all adverse events, protocol waivers, deviations and violations
Complies with all study protocol, SOP and reporting requirements in a timely manner
Responsible for completion of all required documentation with keen focus on the integrity of the data submitted by careful source document review, monitoring for missing data and/or inconsistencies.
Maintains thorough and accurate records per regulatory/compliance standards at all times including but not limited to data for potential inspection; signed informed consents, source documentation, drug dispensing logs, subject logs, and all study related communication
Creates study specific tools for source documentation when not provided by sponsor
Collects, completes and enters data into study specific forms and/or electronic data capture system
Appropriately handles and records all specimens; prepares specimens for shipment; tracks all shipments; tracks all inventory and calibrations.
Attends relevant meetings (e.g. SIVs, PSSVs, IMVs, COVs, audits); assists Sponsor and FDA with any audits and responds to any monitoring/audit findings
Actively communicate with stakeholders as appropriate (Sponsor, IRB, vendors) and maintain active communication on status of each study with PI and management as directed
Works in clinic to operate clinic cleanly, safely and efficiently
Prepares exam and treatment rooms per cleaning protocols; assists with all processes (within scope of certification) to maintain inventory of supplies, medication, and equipment necessary for the operation of the clinic.
Keys data into EMR/forms to maintain accurate office and patient records
Organizes tasks to facilitate smooth work/patient flow
Schedules and registers patients; referrals to specialists as appropriate
Faxes and files forms; answer telephones; receives packages
Adheres to all company policies and procedures, business conduct and work compliance standards
Will be required to travel and work at multiple clinics within a reasonable driving distance from home clinic
Any other task reasonably requested by company to meet its goals