Study coordinator job description

This is an integral position on our team. Successful candidate will handle multiple protocols, planning and coordinating patient participation in a drug trial. Regular status updates for the rest of the team is critical. In addition the Study Coordinator will assist in the maintenance of all study related Case Report Forms (paper or electronic) and will understand the ethical issues involved in human subject research, adhering to the Federal Regulations governing research.
Some of the Study Coordinator responsibilities include,

Will have regular communication with each CRA (Clinical Research Assistant) involved with assigned protocols.
Monitor the overall day-to-day conduct of assigned studies in accordance with the specified protocol requirements, Standard Operating Procedures, and Good Clinical Practice to ensure integrity regarding all aspects of the study.
Reviews forms created or revised for assigned trials to assure protocol compliance.
Maintains files using standardized study document labeling and filing procedures.
Implement initial protocol and amendments, train staff who will be involved in patient treatment and management.
Maintains an up to date contact list.
Assists with patient screening and determination of eligibility.
Facilitates the informed consent process ensuring that consent is appropriately completed.
Prepares and manages source documents according to standard operating procedures.
Recognize deviations to the protocol and work with management and staff to address corrective actions.
Will assist CRA with case report form completion and query resolution.
Will work with the Principal Investigator to complete and submit Serious Adverse Event reports.
Closeout related activities in conjunction with the CRA.
Will provide documentation for all deviations whether related to the protocol or SOP.
Ensure that all team members involved understand and adhere to assigned protocols.
Bachelors degree - preferred, in life sciences. Additional demonstration of clinical research knowledge as evidenced by the use of either CCRP or CCRC credentials is highly desirable.
Knowledge and training in general office administration skills, including computer applications, filing systems, etc. Familiarity with medical terminology desirable.
Demonstrated ability to accurately and efficiently complete assignments in Clinical Investigations and demonstrated capability to perform the data review and CRF completion in its entirety with minimal direction.
Prior experience in clinical trials coordination.
Ability to communicate ideas in a non-confrontational manner to multiple audiences and forums.

Specialized research professional working with and under the direction of the Principal Investigator (PI) and Project Director. The position will be in the Center for Palliative Care Research in Aging. The study coordinator will have a primary role in coordinating a NIH-funded clinical trial of an intervention to improve infection management in nursing home residents with dementia. The trial will be led by the research team at the Hebrew SeniorLife Marcus Institute for Aging Research but the participating nursing homes are located in Iowa and are members of the (Iowa Health Care Quality Network. Responsibilities will include facilitating and coordinating daily study activities, and liaising with the team in Iowa to roll out the intervention in the nursing homes. The study coordinator will be responsible for planning and tracking basic clinical trial project management activities such as; organizing regular project planning meetings with investigators, preparing and updating the study protocol, regular tracking of participant accrual, preparing reports to a data safety monitoring board (DSMB), and submitting materials to an institutional review board (IRB). The study coordinator will also prepare data collection instruments in REDCap and work with the data programming team to ensure adequacy of data collection. The Study Coordinator will work with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the study. Must have the ability to work on multiple activities, prioritize tasks, develop work flow, and meet study deadlines. Must be able to work with minimal supervision, be self-motivated, able to work independently and as a part of a team. Must have good problem-solving skills, be able to provide leadership to the team when required, and oversee the work of research assistants in the field.

• Organization of study start-up (writing standard operating procedure (SOP) manual, development of electronic data collection tools, broad study organization).
• Oversee execution of study protocol (data gathering, randomization, fidelity to intervention).
• Oversee data management (ensure electronic data capture aligns with manual of operations).
• Coordinate and attend all regular study meetings, and prepare documents and report to the Institutional Review Board and Data Safety and Monitoring Board.
• Prepare tracking reports to be shared with the PI and study staff.
• Prepare IRB documents in collaboration with the Project Director and PI. File adverse events reports with the IRB and other governing boards, such as DSMB, according to established protocol.
• Act as a liaison between the Iowa Network and research team to ensure efficient communications related to the study research.
• Oversee printing and distribution of trial intervention materials to the Iowa Network facilities
• Additional responsibilities as required.
• The above covers the most significant responsibilities of the position. It does not, however, exclude other duties, which would be in conformity with the level of the position. Completes special projects as assigned.
Qualifications:
• College degree, Masters preferred, with 3 years of research experience
• Must have the ability to work on multiple activtiess, prioritize tasks, develop work flow, and meet study deadlines
• Must be able to work with minimal supervision, be self-motivated, able to work independently and as a part of a team. Must have good problem-solving skills, be able to provide leadership to the team when required, and oversee the work of research assistants in the field.
• Must have previous experience with data collection, data validation, and data management.
• Must have demonstrated knowledge using Word, Excel, Powerpoint and REDCap
• Must have the ability to learn and adapt to new technologies and be able to trouble-shoot technical problems with field data acquisition, data transfer, and data validation.
• Must demonstrate respect and professionalism regarding subjects’ rights, individual needs, and a working knowledge of HIPAA Protected Health Information regulations.
• Must demonstrate flexibility in regards to project demands, adapting to schedule changes, coverage gaps, and unanticipated study needs.
Hebrew SeniorLife requires all employees to be fully vaccinated against COVID-19 as a condition of their employment. All new hires must be fully vaccinated, which includes any recommended COVID-19 boosters, before their start date. Any exemption requests for medical or religious reasons will be considered on a case by case basis and must be processed prior to any start date.
Hebrew SeniorLife is an equal employment opportunity employer. All employment decisions are based on merit, qualifications, and competence and not influenced or affected by race, color, religion, age, gender, national origin, ancestry, marital status, military status, veterans status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by federal, state, or local law.
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1iPHuZIHTO

This individual will play 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.

The employee, working closely with study team members under the direct supervision of a Study Manager, will support other study team members in order to achieve study objectives and corporate goals, including:
Develop strong working relationships and maintain effective communication with study team members. Become the point of contact for the clinic as well as the sponsor for clinic related activities. Manage multiple concurrent trials Completes all protocol related training 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, nonclinical 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.


QUALIFICATION AND EDUCATION REQUIREMENTS

Associates Degree or BS/BA in Life Science or related discipline Previous nursing experience in a clinical setting a plus At least one year of experience in coordinating clinical trials Prior training in GCP requirements Strong interpersonal skills with attention to detail a must. 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.


WORKING CONDITIONS

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

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.
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.