Medical Assistant / Clinical Research Coordinator

POSITION SUMMARY

The Clinical Research Coordinator (CRC) is responsible for a variety of activities in support of clinical research studies.  The CRC works closely with and carries out the directives of the Director of Clinical Research in all aspects of the care and treatment of clinical research subjects in compliance with study protocols throughout the research study.   The CRC is responsible for his/her assigned portfolio of studies as it relates to, but not limited to, the following areas: regulatory requirements; informed consent; recruitment; accurate and timely completion of case report forms, patient visits (paper and electronic); data entry; laboratory; test article; adverse event reporting; and study close out. The CRC is required to have knowledge of protocol design and Good Clinical Practices (GCP) as set forth by the Federal Regulations and International Conference of Harmonization (ICH) Guidelines for the protection of human subjects and the conduct of clinical research required Knowledge of the International Air Transport Association (IATA) regulations for the transportation of Dangerous Goods is also necessary.  Under the direction of the Director of Site Operations, the CRC will help ensure protocol compliance, Investigational Article accountability and proper follow-up during the clinical trial.

TYPICAL PHYSICAL DEMANDS:  Physically capable of lifting, moving or transporting supplies, medical records and equipment within reasonable weight limits.  Physically capable of reading and reviewing handwritten chart notations.  Physically capable of bending, sitting or standing for extended periods of time, reaching and climbing to retrieve or store medical records.  Physically capable of manually entering data into an electronic data base using a keyboard.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

TYPICAL WORK CONDITIONS:  Fast-paced clinical research center environment.  Must be able to adjust and adapt to changing conditions.

QUALIFICATIONS, REQUIREMENTS and EDUCATION:  Minimum: High School Diploma with two years clinical research coordinator experience.  Preferred:  Associates Degree in a medical related field and one-year clinical research experience.  Candidate will be required to sit for and successfully obtain CCRC after two years clinical research coordinator experience.  Travel within the USA to attend Investigator meetings for new clinical trials may be required.

ESSENTIAL SKILLS:

• Maintain the highest level of professional conduct in the presence of investigators, subjects, research staff, sponsors, etc.
• Able to perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study specific protocols
• Computer skills with capability of using clinical trial databases, electronic data capture, Microsoft Word Office
• Ability to communicate clearly using excellent verbal and written communications skills
• Possess exceptional organizational and prioritization skills as demonstrated by planning objectives and strategies to ensure that the process/requirements for the flow of clinical research information is optimized; such as: charting is completed accurately and thoroughly and subject binder provided to Data Entry for EDC processing within 48 hours of the patient visit.
• Ability to problem-solve, prioritize quickly and accurately and multi-task to facilitate work flow
• Utilize negotiation skills to achieve expected results.
• Ability to work independently in a fast-paced environment, as well as, work collaboratively as a team
• Possess and utilize excellent interpersonal skills with patients, staff, and others
• Meticulous and detail oriented
• Ability to perform ECG, Phlebotomy, Urinary Pregnancy Test
• Ensure proper collection, processing and shipment of bio specimens (e.g., centrifuge, freezing, refrigeration.

DUTIES AND RESPONSIBILITIES:              

Regulatory:

• Maintains a copy of all required Regulatory Documents for assigned portfolio of studies
• Assists DSO and/or DCR in preparing for IRB submissions, protocol revisions, periodic or final reports, and submitting timely and accurate regulatory documents to sponsors, as needed.
• Maintains Master File with copies of all IRB communications for assigned portfolio of studies
• Supports the safety of clinical research participants
• Adhere to Good Clinical Practices and the study protocols
• Any other duty which may be assigned to ensure all regulatory documentation occurs in a timely and thorough manner.

Clinical Trial Process:

• Assists in facilitating a