Kelly Science and Clinical FSP is currently seeking a CRC II for in Horsham, PA. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Clinical Research Coordinator II (6 Month Assignment with potential for renewal)

Job Description:

The Clinical Research Coordinator II plays a key role in supporting the execution of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, the ability to prioritize, a “can-do” attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team-building skills. The employee, working closely with study team members, will support other study team members in order to achieve study objectives and corporate goals.

ESSENTIAL DUTIES:

• 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 Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs), GCP guidelines and documents data according to ALCOA.
• Perform other duties as required and/or assigned.

QUALIFICATIONS:

• 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:

• Associate degree in life science or healthcare related field, bachelor’s degree preferred
• Minimum 1 year of experience coordinating clinical trials
• Previous nursing experience in a clinical setting a plus
• CCRC certification is a plus

ENVIRONMENT:

This job operates in a professional clinical research office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

The clinical work environment involves exposure to potentially dangerous materials and situations that require extensive safety precautions and may include the use of protective equipment. Additionally, the incumbent will work with blood or blood-borne pathogens and will require prolonged glove wear.

Approximately 25 – 30% travel may be required to support the position’s responsibilities. May be required to travel to support other sites with ongoing trial activities.

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.

Occasionally reach/work above shoulders, twist/bend/stoop/squat, grasp forcefully, lift/carry/push/pull objects that weigh up to 20 pounds.