Clinical Research Coordinator I - Emergency Medicine

The Clinical Research Coordinator I manages elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; startup activities launch activities day to day management of a study and study closure activities.

Essential Functions:

• Recruits consents and enrolls subjects according to ICH/GCP regulations and subjects rights through institutional IRB federal and state regulations; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate.
• Ensures that the subject meets inclusion/exclusion criteria; alerts the investigator when the subjects safety is in jeopardy there is a protocol deviation or when the subject requests premature study termination.
• Collects and manages research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures.
• Prepares and processes human specimens for use in research studies. Collects blood urine and other samples as needed according to skill level and certifications. Performs CLIA waived laboratory assessments. Such activities may be performed independently and may require evening and weekend hours.
• Completes screening sheets and recruitment logs.
• Creates source documents that facilitate systematic data collection and/or aid in protocol and management and record keeping; and conducts accurate and timely subject data collection.
• Collaborates coordinates and schedules subject study visits with other hospital services and the PI/subI.
• Adheres to departmental quality control guidelines.
• Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRFs are completed prior to monitoring visits.
• Maintains regulatory binder and documents.

Education Requirement:

Associates degree STNA PCA LPN MA or equivalent workrelated experience required. BA/BS preferred.

Licensure Requirement:

(not specified)

Certifications:

Ability to obtain CRA/CRC certification in a timely manner.

Skills:

Understanding of medical terminology and clinical research preferred.
Working knowledge of PCs and word processing and data management software
Demonstrated analytical skills with accuracy and attention to detail.
Excellent verbal and written communication skills.
Goaloriented and selfdirective
Strong organizational and interpersonal skills.
Ability to actively participate as a team player.

Experience:

Previous experience in clinical research or health care related field preferred.

Physical Requirements:

OCCASIONALLY: Cold Temperatures Fume /Gases /Vapors Loud Noises Reaching above shoulder Squat/kneel

FREQUENTLY: Bend/twist Biohazard waste Blood and/or Bodily Fluids Chemicals/Medications Communicable Diseases and/or Pathogens Lifting / Carrying: 010 lbs Lifting / Carrying: 1120 lbs Lifting / Carrying: 2140 lbs Machinery Patient Equipment Pushing / Pulling: 025 lbs Pushing / Pulling: 2640 lbs Pushing / Pulling: 4160 lbs Pushing / Pulling: 61100 lbs Sitting Standing Walking

CONTINUOUSLY: Audible speech Computer skills Decision Making Depth perception Flexing/extending of neck Hand use: grasping gripping turning Hearing acuity Interpreting Data Peripheral vision Problem solving Repetitive hand/arm use Seeing Far/near

Additional Physical Requirements performed but not listed above:

(not specified)

Accuracy and Attention to Detail Basic Understanding (Meets Expectations) Associates Degree Effective Communications Working Knowledge (Meets Expectations) Initiative Working Knowledge (Meets Expectations) Managing Multiple Priorities Basic Understanding (Meets Expectations) NCH Clinical Research Compliance Basic Understanding (Meets Expectations) NCH Core Values Basic Understanding (Meets Expectations) Planning and Organizing Basic Understanding (Meets Expectations) Problem Solving Basic Understanding (Meets Expectations) Quality Management Basic Understanding (Meets Expectations) RES107 Certified Clinical Research Coordinator (CCRC) Association of Clinical Research Professionals ACRP RES108 Certified Clinical Research Professional (CCRP) The Society of Clinical Research Associates SOCRA Service Excellence Working Knowledge (Meets Expectations) Tolerance for Ambiguity and Stress Basic Understanding (Meets Expectations)

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified nor is it intended to limit or modify the right of any supervisor to assign direct and control the work of employees under their supervision. EOE M/F/Disability/Vet