Clinical Research Coordinator

GENERAL SUMMARY/ OVERVIEW STATEMENT:

Assists professional staff (Principal Investigator) in coordinating behavioral pharmacological clinical trials and imaging/biomarker trials according to study guidelines, including performing testing, recruiting participants for studies, scheduling appointments, assuring completion of visits and accurate data collection and entry, assisting in IRB submissions, and interacting with regulatory personnel for local and multicenter trials. In addition, making independent judgement of suitability of potential participants for clinical

trials, developing and implementing patient recruitment strategies, recommending changes to protocols and overseeing

the work involved.

Principle Duties and Responsibilities:

• this is a full time onsite position

• Conducts and supports scientific research.

• Coordinates the implementation, both internally and externally, of clinical research studies.

• May develop, design and interprets scientific research protocols/experiments including, data collection systems and

institutional review board approval. Manages/facilitates IRB submission, additions and changes.

• Initiates and maintains contact with study participants. Responsible for screening applicants, ensuring they meet appropriate criteria, and makes independent judgement as to the suitability of their participation. May be required to perform clinical tests such as phlebotomy, EKGs, structured interviews, ECT. Administers study related behavioral

questionnaires.

• Working in conjunction with Principal Investigator and/or Research Manager, develops and implements patient recruitment strategies.

• Develops, organizes and /or maintains the study database. Responsible for data validation and quality control.

• Investigates, creates, and develops new methods and technologies for research advancement.

• Contributes to the scientific literature, reports, journals and presentations. Performs literature searches, as appropriate.

• Responsible for oversight of research assistant work, training and orienting new staff. May serve as a team leader or in a

supervisory capacity in a smaller area.

• All other research and administrative duties as assigned by Principal Investigator

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Please note, the functions below are representative of major duties that are typically associated with these positions. Specific responsibilities may vary based upon departmental needs. Similarly, not all duties that have been outlined will be assigned to each position.

• Collects & organizes patient data

• Maintains records and databases

• Uses software programs to generate graphs and reports

• Assists with recruiting patients for clinical trials

• Obtains patient study data from medical records, physicians, etc.

• Conducts library searches

• Verifies accuracy of study forms

• Updates study forms per protocol

• Documents patient visits and procedures

• Assists with regulatory binders and QA/QC procedures

• Assists with interviewing study subjects

• Administers and scores questionnaires

• Provides basic explanation of study and in some cases obtains informed consent from subjects

• Performs study procedures, which may include phlebotomy.

• Assists with study regulatory submissions

• Writes consent forms

• Verifies subject inclusion/exclusion criteria

• Performs administrative support duties as required

A Clinical Research Coordinator II performs the duties of a Clinical Research Coordinator I (above) and may also:

• Maintain research data, patient fields, regulatory binders and study databases

• Perform data analysis and QA/QC data checks

• Organize and interpret data

• Develop and implement recruitment strategies

• Act as a study resource for patient and family

• Monitor and evaluation lab and procedure data

• Evaluate study questionnaires

• Contribute to protocol recommendations

• Assist with preparation of annual review

• May assist PI to prepare complete study reports

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Careful attention to details

• Good organizational skills

• Ability to follow directions

• Good communication skills

• Computer literacy

• Working knowledge of clinical research protocols

• Ability to demonstrate respect and professionalism for subjects' rights and individual needs

The Clinical Research Coordinator II should also possess:

• Ability to work independently and as a team player

• Analytical skills and ability to resolve technical problems

• Ability to interpret acceptability of data results

• Working knowledge of data management program

Qualifications: preferred. Masters degree in Psychology related field or equivalent education in scientific field of research. Five to seven years of

direct research experience.

Skills/Abilities/Competencies Required:

• Ability to work well independently, prioritizing work according to and within established study protocols

• Excellent organizational skills to accomplish a variety of responsibilities and to establish and maintain efficient systems.

• Excellent interpersonal skills to be able to interact with a variety of people in person and on the telephone.

• Ability to work under stress and within deadlines; the clinical research setting is a very busy and demanding environment.

• Analytical skills and the ability to resolve technical or research problems and issues and to interpret the acceptability of data results.

• Knowledge of research protocols

• High degree of computer literacy - Knowledge of data management programs

• Professionalism and respect at all times

Working Conditions: Has desk in office environment, meets with collaboration researchers in a variety of locations, and works at a number of scanners located in various parts of the hospital. Must be able to travel between hospital and research buildings carrying study documents and materials.

Supervisory Responsibility: Responsible for training and orienting new staff. May serve as a team leader or supervisor in a smaller research setting.

EEO Statement