Clinical Research Coordinator

Ophthalmology Associates Des Peres , MO 63131

Posted 2 weeks ago

Title: Clinical Research Coordinator

Company: Ophthalmology Associates

Location: Des Peres, MO

Perks:

  • Full Benefits Package - Medical, Vision, Dental and Life Insurance

  • 401k + Employer Matching

  • Paid Time Off and Paid Holidays

  • Paid Maternity Leave

  • Optical Education Reimbursement

  • Competitive Base Pay

Hours:

  • Full Time

  • Our offices are open Monday-Friday 8:00am-5:00pm. You may need to work a little earlier/later as needed.

Position Overview:

Complete clinical trial assignments in an accurate and timely manner under the close supervision of a senior staff member. Perform research activities according to Food and Drug Administration (FDA) regulations, ICH Guidelines, Good Clinical Practices (GCP) and standard operating procedures.

Essential Duties and Responsibilities: The following are general responsibilities associated with the job and are listed in order of greatest to least amount of time spent on the duties.

  • Performs study tasks as per study protocol.

  • Follows FDA regulations, Good Clinical Practices, HIPAA and OSHA guidelines.

  • Takes direction from the Manager and/or Executive Director regarding new or existing clinical trials.

  • Maintains up-to-date Regulatory documents for each study.

  • Assists in IRB submissions, continuing review, renewals, etc.

  • Generates reports as requested for prescreening purposes

  • Direct patient contact including obtaining informed consent, and follow-up appointments as required by the protocol.

  • Maintains confidentiality related to medical records and other data.

  • Works with study monitors to ensure accurate completion of Study Protocol.

  • Maintains Case Report Forms, study databases and regulatory Binders as required per study.

  • Perform other clinical research tasks as required per protocol (i.e. lab processing and study specific assessments).

  • Completes internal audits as requested on internal research data.

  • Job may require other duties as assigned.

Education and Experience: The minimum level of education and experience required to perform the job at a satisfactory level.

  • Bachelor's Degree required.

  • Minimum of two years of clinical research experience preferred.

  • If Registered Nurse, an active Nursing license.

Knowledge, Skills, and Abilities: The minimum level of knowledge, skills, and abilities to perform the job at a satisfactory level.

  • Knowledge of medical terminology, anatomy and physiology.

  • Knowledge of Federal Drug Administration (FDA) and Good Clinical Practice (GCP) regulations.

  • Knowledge of word processing (MS Word or WordPerfect).

  • Skill in gathering, interpreting and reporting information.

  • Ability to exercise initiative, problem-solving, decision-making.

  • Decision Making: Common decisions made in the job and the level of review or autonomy needed to finalize such decisions.

  • May make recommendations regarding policies associated with the job's purpose and essential responsibilities.

  • Work Environment: Environmental or atmospheric conditions commonly associated with the performance of the functions of this job.

  • General office and lab conditions.

Physical Requirements: Activities that are commonly associated with the performance of the functions of this job. The physical demands described below are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

  • Work effectively at a computer for up to eight hours per day.

  • Regular attendance is a necessary and essential function.

If you need assistance with this application, please contact (636) 227-2600. Please do not contact the office directly - only resumes submitted through this website will be considered.

EyeCare Partners is an equal opportunity/affirmative action employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.


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