Atlanta Heart Specialists, LLC (AHS) has built a reputation for unparalleled excellence in cardiac care serving greater Atlanta through 8 offices and 16 physicians. In addition, AHS Research is a nationally and internationally recognized Cardiac research program. We are looking for an experienced, detail-oriented Clinical Research Coordinator to lead our Research team at our Johns Creek/Cumming location. www.ahsmed.com.
Key Clinical Research Coordinator Duties and Responsibilities
- Ensure compliance with study protocols, regulatory requirements, and HIPAA guidelines.
- Provide subject care and data collection procedures in adherence with the assigned study protocol and in accordance with good clinical research principles.
- Ensure timely completion of study start-up items, including IRB approval of protocols, informed consent forms, etc.
- Review subject charts, database records, and other sources to prescreen and identify potential subjects for inclusion in study based on study inclusion criteria.
- Recruit, screen, and enroll study participants.
- Confer with subject and physician to explain purpose of study. Explain diagnostic procedures and method of treatment to answer subject and family concerns. Obtain written consent for subject to participate in a study prior to initiation of any protocol procedures.
- Maintain accurate records of the receipt, inventory, and dispensation of study drug and materials. Work with the nursing staff to administer study drug to research subjects.
- Obtain and coordinate subject blood samples, cultures, tissues, and other specimens for laboratory analysis as described in study protocol.
- Collect pertinent information and data from subject charts and records, subject interviews, and other sources. Complete case report forms (CRFs) in accordance with research protocol guidelines.
- Review CRFs, source documentation, and study files with representative from sponsor, consortium, or Food and Drug Administration (FDA) at each visit. Make necessary corrections to CRFs and submit requested documentation in a timely manner.
- Comply with standard operating procedures of the sponsor, institutional review board (IRB), and consortium involved with the trial.
- Compile and submit reports, documents, and correspondence as necessary to the IRB, sponsor, and consortium.
Qualifications
- RN, LPN, MA, foreign MD,or other health professional with strong clinical background and experience.
- CRC research certification and prior clinical research experience is a must.
- Experience with reviewing, negotiating, and managing study budgets and invoices is a plus.
- Proficiency in electronic data capture systems and Microsoft Office Suite.
- Excellent interpersonal skills with ability to develop good relationships effectively with study sponsors, staff members, patients, and physicians.
- Requires a meticulous nature with excellent organizational skills and strong work ethic.
- Strong clinical knowledge base with sound independent judgement.
- Strong understanding of GCP, ICH guidelines, and FDA regulations.
- Ability to work independently and as part of a team.
- Seeking a leader who can help develop and grow a clinical research study site and overall program.
Salary and benefits are commensurate with experience.
If this challenging, but rewarding position appeals to you, please email your resume to set up an interview. Please be prepared to provide references.
Job Type: Full-time
Pay: From $34.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Experience level:
Medical specialties:
Schedule:
- 8 hour shift
- Monday to Friday
Ability to Relocate:
- Suwanee, GA 30024: Relocate before starting work (Required)
Work Location: In person