GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Senior Clinical Research Coordinator (Sr. CRC) works independently under minimal supervision to support the team by maintaining clinical research collection protocols. The Sr. CRC will ensure timely collection of protocol related samples and ensure study compliance with all state, federal, and IRB requirements. In addition, the Sr. CRC assist management in the areas of Quality Control and Training & Development and may provide input into the assessment of departmental procedures. This position involves direct patient contact. This individual will also screen patients for protocol eligibility, obtain informed consent, and register study participants to clinical trials. CRC will process blood and tissue samples. This position will require tasks be performed in a range of hospital settings including Pathology, Surgery, and Oncology.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1) RECRUITMENT AND RETENTION OF STUDY SUBJECTS:

* Determine eligible patients and verify eligibility requirements.

* Obtain informed consent prior to study entry.

* Complete study orders and other patient forms.

* Capture patients at follow up appointments and coordinate additional blood samples.

2) MANAGEMENT OF STUDY DATA:

* Data entry.

* Perform quality control checks on data.

* Maintain research files.

* Plans, performs, and designs statistical analyses

* Designs research protocols in conjunction with PI

* Maintain enrollment logs, track pathology specimens as they move through various stages of analysis, monitor participating physicians' schedules for pre-op, surgery and post-op appointments of eligible patients.

3) OTHER RESPONSIBILTIES:

* Assist with all IRB related protocol changes and continuing reviews

* Provide information to colleagues about patient consent and specimen collection protocols

* Participate in conference calls and other meetings

* Collecting, processing and storing blood and tissue samples

4) Responsibilities will consist of assisting Management with the following:

* Identify changes associated with Standard Operating Procedures and develop processes to ensure compliance

* Training of new staff, review work of trainees

* Participate in the recruitment process for new hires

* Mentor junior staff

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

* Excellent written and verbal communication skills

* Must have careful attention to details and perform accurate data entry

* Ability to follow directions

* Must practice discretion and adhere to hospital confidentiality guidelines at all times

* High level of time management and organizational skills

* Ability to design, prepare, deliver, and evaluate clinical programs

* Demonstrated ability to successfully manage multiple projects

* Strong oral and written communication skills, organization, time management and interpersonal skills

* Administrative skills to collect, record, track and report patient and study information to meet regulatory requirements

* Computer literacy

* Ability to prepare/monitor budgets

* Ability to meet requirements of varying funding sources

* Knowledge of clinical research protocols and familiarity with the consenting process for health research studies strongly preferred

* Knowledge of current and developing clinical research trends

* Ability to identify problems and develop solutions

* Ability to work independently and display initiative to introduce innovations to research study

QUALIFICATIONS:

* BA/BS required, MA/MS/MPH preferred

* Minimum 3-5 years of directly related experience required

SUPERVISORY RESPONSIBILITY (if applicable):

Orients and trains new staff and may mentor junior staff

WORKING CONDITIONS:

Duties will primarily be performed in an ambulatory and laboratory setting