Clinical Research Coordinator

Boston, MA, United States

Job Description - Clinical Research Coordinator (3295501)

Clinical Research Coordinator - ( 3295501 )

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

- 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.

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

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

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

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

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.

- 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

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

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.

Primary Location Primary Location MA-Charlestown-MGH Charlestown HealthCare Center

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