JOB TITLE – Clinical Research Associate

GENERAL SUMMARY OF DUTIES – Perform routine site monitoring visits, participate in site selection, site initiation and study closure activities to ensure that the conduct of the clinical trial is being conducted according to the approved protocol, amendments, company SOPs, and all regulations and guidelines.

DUTIES INCLUDE BUT ARE NOT LIMITED TO:

 * Assist in the Investigator selection and qualification process.

* Assists in planning and preparation of Investigator Meetings

* Assists in the development of patient recruitment strategy

* Attendance at Investigator Meetings.

* Perform pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits.

* Ensure IRB certification is current and all IRB documentation is in order.

* Maintains site monitoring schedule.

* Document and report on clinical study progress.

* Ensures patients safety is maintained and informed consent procedures are carried out

* Update investigative site team of any changes in study conduct and documentation requirements.

* Ensure continued acceptability of the investigator, clinical site team and facility.

* Review clinical data, source documentation, CRF, and investigative site regulatory files.

* Work closely with data management and site to resolve discrepancies.

* Ensure investigational product accountability accuracy and oversee investigational product inventory.

* Meets with clinical study sponsor representatives as requested.

* Attends meetings as assigned and reports on actions.

* Participates in educational activities and programs.

* Maintains strictest confidentiality.

* Works closely and effectively with all other department personnel.

* Assists other staff as requested and performs other related work as needed.

* Functions as a mentor for junior team members

* Throughout the conduct of the conduct of the clinical trial assesses adherence to SCRI SOPS,  Good Clinical Practice (GCP) and ICH regulations and guidelines.

* Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”.

* Up to 100% travel may be required.

KNOWLEDGE, SKILLS & ABILITIES - This position requires the following minimal requirements:

* Proficient in Microsoft Office software, including Word, Excel, and Access; high computer literacy and ability to learn new software if required

* Detail-oriented with knowledge of scientific, medical, and regulatory terms.  Excellent English written and oral skills.

* Knowledge of GCP, GLP, and GMP

* Proven ability to multi-task in fast paced environment is essential.

* Strong interpersonal, communication, and organizational skills.

* Ability to manage, organize and make decisions.

EDUCATION

Bachelor’s degree in life sciences or nursing

EXPERIENCE

Three years direct monitoring experience