OVERVIEW:
The Clinical Research Coordinator (CRC III) manages the key global relationships and serves as the primary liaison among internal and external stakeholders, ensuring timely and professional communication regarding study progress and key events. This role involves overseeing multiple concurrent trials, mentoring junior team members, and ensuring adherence to ethical and regulatory standards throughout the research process. Key responsibilities include conducting informed consent procedures, supporting participant safety by reporting adverse events, coordinating study visits, and managing essential study documentation. The CRC III plays a pivotal role in problem-solving and process improvement to enhance study efficiency and compliance.
RESPONSIBILITIES:
- Develop strong working relationships, maintain effective communication with study team members.
- Serve as a point of contact for the clinic as well as the sponsor for clinic related activities.
- Support and work across multiple concurrent trials
- Complete all protocol related training by due dates.
- Perform patient/research participant scheduling
- Collect patient/research participant history
- Collect and maintain source documentation
- Perform data entry and query resolution
- Support the collection and review of required essential study documents and reports.
- Order supportive study supplies (e.g., contracts, IXRS, lab kits, nonclinical supply materials, imaging and laboratory handling manuals, etc.).
- Adhere to an IRB approved protocol
- Conduct the informed consent process of research subjects, once trained.
- Support the safety of research subjects, and report adverse events
- Coordinate protocol-related research procedures, study visits, and follow-ups
- Assist with the screening, recruiting, and enrollment of research subjects.
- Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close- out activities. Documentation of PSV and SIV activities.
- Collect, process, and ship laboratory specimens
- Follow ethical and professional codes of conduct and escalate noncompliance as needed
- Adhere to the study plan by ensuring that all approvals are in place, vendors are qualified
- Comply with Clinic and Sponsor policies, standard operating procedures (SOPs), GCP guidelines and documents data according to ALCOA.
- Perform other duties as required and/or assigned.
REQUIREMENTS:
- Knowledge of clinical trial terminology and practices required
- Prior GCP training and ability to explain the importance of GCP guidelines
- Ability to identify and explain key protocol elements and perform study tasks
- Demonstrated understanding of the basic participant safety requirements including safety reports, ICF elements, and role of the IRB.
- Excellent verbal and written communication skills, including the ability to convey ideas, information, and suggestions clearly and effectively.
- Excellent interpersonal and customer service skills
- Strong organizational skills, including the ability to accomplish multiple tasks within the agreed-upon timeframes through effective prioritization of duties and functions in a fast-paced environment.
- Self-motivated and ability to act and operate independently with minimal daily direction from manager to accomplish objectives
- Strong analytical and problem-solving skills
- High attention to detail and accuracy
- Ability to maintain confidentiality with HIPAA guidelines, patient matters and other sensitive information.
- Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required.
- Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and with clinical trial master filing systems
EDUCATION AND EXPERIENCE:
- ·Bachelor's Degree (BS/BA), in life sciences or healthcare field preferred
- Minimum 5 years of experience coordinating clinical trials, including the activities listed above
- ·At least 2 years of experience within clinical research providing oversight of a project or a clinical team preferred CCRC certification is a plus
- Previous nursing experience in a clinical setting a plus
- Phlebotomy experience a plus
- Experience administering subcutaneous, intramuscular, and IV medications a plus
PHYSICAL DEMANDS:
- The physical requirements described here are representative of those that must be met by an employee to successfully perform the functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee may be required to:
- Regularly work at a desk using a computer for prolonged periods.
- Perform repetitive motion with substantial movements (motions) of the wrists, hands, and/or fingers.
- Regularly communicate via e-mail, telephone, chat, webcam (remote sessions such as MS Teams or Zoom), so others will understand and exchange accurate and timely information.
- Frequently stand/walk, grasp objects, and perform lightly/fine manipulation of objects.
- Occasionally move safely over uneven surfaces.
Pay: $60,000.00 - $70,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Work Location: In person
