Clinical Research Coordinator

Job Title:

Clinical Research Coordinator Reports to:

Center Manager and Research Regulatory/QC Manager Classification:

Non-exempt About Exer Exer's mission is "creating convenient access to ER doctors in an affordable and caring environment." Exer can take care of about 80% of the procedures being handled in the ER today at a fraction of the price and in a much more comfortable setting with shorter wait times. Our first core value is "Patient Centered" care and this is what Exer is all about. We want to transform the urgent care space and be a role model to other sectors of healthcare as to what healthcare can be, including making clinical research opportunities accessible to our patients who may volunteer to evaluate new technologies and medications. Job Summary 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. Major Duties & Responsibilities Research

• 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 Other
• 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 Job Related Skills/Competencies
• 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) Education/Qualifications
• High school diploma
• 1-3 years of clinical research experience required, including knowledge of clinical trials terminology, processes, forms and reporting
• Phlebotomy certificate preferred
• Current Medi-Waste Training for: Bloodborne Pathogens for Healthcare, GHS Hazcom, HIPAA, HITECH & Omnibus
• Computer skills Physical Requirements/Working Conditions
• 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)