JOB SUMMARY

The Study Manager (Clinical Research Coordinator II) plays a key role in assisting in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills.

RESPONSIBILITIES

The Study Manager (Clinical Research Coordinator II) will be responsible for coordinating efforts with other study team members in order to achieve protocol objectives and corporate goals.

Key Responsibilities

• Ability to recognize and synthesize information about the organizational climate and partner with key individuals to accomplish organizational goals
• Develop strong working relationships
• Establish and maintain effective communication with key stakeholders and team members
• Foster strong working relationships with the clinic and serve as the sponsor for clinic related activities
• Manage multiple concurrent trials
• Assist with mentoring and training study team members
• Completes all protocol related training required for the position
• Perform patient/research participant scheduling
• Collect patient/research participant history
• Collects and maintains source documentation
• Performs 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, non-clinical supply materials, imaging and laboratory handling manuals, etc.)
• Adhere to an IRB approved protocol
• Assist in the informed consent process of research subjects
• Support the safety of research subjects, report adverse events
• Coordinate protocol related research procedures, study visits, and follow-up
• Assist with the screening, recruiting and enrollment of research subjects.
• Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close out activities
• Collect, process and ship laboratory specimens
• Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines
• Other duties as defined by department and company leaders

QUALIFICATIONS AND EDUCATION REQUIREMENTS

Required

• 3+ years of experience coordinating clinical trials to be able to perform key responsibilities
• BS/BA in Life Science or related discipline
• Previous GCP training and certification
• Demonstrated ability to build strong teams and relationships
• Strong verbal and written skills required
• Strong interpersonal skills with attention to detail
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems
• Ability to travel for Clinic activities, attend investigator meetings or vendor visits/audits, as required
• Strong organization/prioritization skills for the management of multiple concurrent projects

Preferred

• Experience with training and mentoring other clinical research professionals
• Nursing experience in a clinical setting a plus

WORKING CONDITIONS

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

WORKING SCHEDULE

Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.

TRAVEL REQUIREMENTS

Regular local and regional travel is required for this position.

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.

Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.