Clinical Research Coordinator II

Royal Oak - Full time, day shift

Job Scope

May function as study personnel, regulatory specialist or auditor. The CRC II study personnel is responsible for protocol coordination, including subject recruitment, enrollment, implementation, and follow-up of appropriate research protocols. The CRCII study personnel promotes good clinical practice in the conduct of clinical investigations by possessing knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection. The CRC II Regulatory Specialist comprehensively coordinates all processes related to HIC business in order to insure compliance with institutional policies and federal regulations governing human subject research. The CRC II Auditor provides ongoing review of all patient and regulatory materials based on Good Clinical Practices. The CRC II Auditor evaluates accuracy and completeness of documents per regulatory, institutional and study specific requirements. The Auditor's activities will include but are not limited to, review of subject eligibility and screening procedures, review of subject research visits and data collection and review of CRF's, source documents and other essential documents.

Qualifications

• Required Bachelor's Degree or equivalent in a health-related field, two or more years of clinical research experience, and National Research Certification within six months of hire OR five or more years of clinical research experience, and National Research Certification, OR clinical specialist with technician registration or therapist licensure (e.g., Radiation Therapist, Cardiovascular Specialist) and National Research Certification within six months of eligibility.

• Must have good working knowledge of all applicable FDA guidelines and Good Clinical Practices. Required

• CRT-At least one Certification from preferred list - UNKNOWN Unknown Upon Hire preferred
• CRT-Clinical Research Professional, Certified (CCRP) - SOCRA Society of Clinical Research Associates Upon Hire preferred Or
• CRT-Clinical Research Coordinator, Certified (CCRC) - ACRP Association of Clinical Research Professionals Upon Hire preferred Or
• CRT-IRB Professional, Certified (CIP) - UNKNOWN Unknown Upon Hire preferred
• CRT-Basic Life Support (BLS) - AHA American Heart Association Upon Hire preferred Or
• CRT-Basic Life Support (BLS) - ARC American Red Cross Upon Hire preferred

Physical Demands

• Pallet to Waist (6" from floor) > 5 lbs: Seldom up to 50 lbs
• Waist to Waist > 5 lbs: Seldom up to 50 lbs
• Waist to Chest (below shoulder) > 5 lbs: Seldom up to 10 lbs
• Waist to Overhead > 5 lbs: Seldom up to 5 lbs
• Bilateral Carry > 5 lbs: Seldom up to 25 lbs
• Unilateral Carry > 5 lbs: Seldom up to 10 lbs
• Pushing Force > 5 lbs: Occasionally up to 25 lbs
• Pulling Force > 5 lbs: Occasionally up to 20 lbs
• Sitting: Occasionally
• Standing: Frequently
• Walking: Frequently
• Forward Bend - Standing: Occasionally
• Forward Bend - Sitting: Seldom
• Trunk Rotation - Standing: Occasionally
• Trunk Rotation - Sitting: Occasionally
• Squat: Seldom
• Stair Climbing: Seldom
• Crawling / Kneeling: Seldom
• Driving: Seldom
• Reach - Above Shoulder: Occasionally
• Reach - at Shoulder or Below: Occasionally
• Handling: Occasionally
• Forceful Grip > 5 lbs: Occasionally
• Forceful Pinch > 2 lbs: Occasionally
• Finger/Hand Dexterity: Occasionally
• Visual Acuity ¹
  [None = No; Seldom = Yes]: Seldom
• Color Vision (Ishihara) Test
  [None = No; Seldom = Yes]: Seldom

How Corewell Health cares for you

• Comprehensive benefits package to meet your financial, health, and work/life balance goals. Learn more here.

• On-demand pay program powered by Payactiv

• Discounts directory with deals on the things that matter to you, like restaurants, phone plans, spas, and more!

• Optional identity theft protection, home and auto insurance, pet insurance

• Traditional and Roth retirement options with service contribution and match savings

• Eligibility for benefits is determined by employment type and status

Primary Location

SITE - Research Building - 3811 W 13 Mile Road - Royal Oak

Department Name

Research Institute Orthopaedics Clinical Home RIORC

Employment Type

Full time

Shift

Day (United States of America)

Weekly Scheduled Hours

40

Hours of Work<