Clinical Research Coordinator

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The REU is a recipient of a Gates Foundation Grand Challenge Award. The Unit is also a National Center for Translational Research in Reproduction and Infertility, funded by the National Institute of Child Health and Development (NIH). Dr. Seminara, Unit Chief, is PI on an NIH Merit Award (R37) which provides 10 years of funding for her translational studies.

Under the direction of the Program Managers for the Reproductive Endocrine Unit, the Clinical Research Coordinator will work on studies of infertility and reproductive endocrinology. The Coordinator will primarily contribute to the execution of a study that examines the genetic architecture of idiopathic infertility. The Coordinator's tasks may include some or all of, but are not limited to: recruiting and screening participants, consenting participants, performing study visits (including phlebotomy and processing biological samples), maintaining regulatory documents, organizing data, and assisting with data analysis. The Coordinator may also work on other protocols in the Unit's portfolio. They are expected to collaborate closely with the Program Manager, Study Investigators, and other members of the clinical research team.

Interested applicants should include a cover letter in their application.

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.

Coordinates all aspects of successful study conduct, with responsibilities including:

1. Protocol Execution - With minimal supervision from the REU Program Managers, implements study recruitment strategies and study visits.

• Screens potential subjects; when relevant, reviews medical records to verify subject meets inclusion/exclusion criteria
• Obtains informed consent, when appropriate;
• Interacts with study subjects (by phone, email, and in person) before, in between, and during all study visits, provides information/education about the study, and aids with all study procedures such as: remote enrollment, completion of study materials, and phlebotomy;
• Performs biological sample duties: label making, record maintenance, processing, packaging and shipment/receipt;
• Coordinates and interacts with clinical staff as required by protocol;
• Maintains study-specific documents and enrollment tables;
• Contributes to development of new recruitment strategies and procedures.

1. Regulatory Compliance - With minimal supervision from the PI and/or Program Manager, assists with compliance to all regulatory requirements.

* Verifies accuracy of study forms, and updates study forms per protocol;

* Contributes to development and maintenance systems for QA/QC;

* Assists with study regulatory submissions, and maintains regulatory binders for protocols;

* Drafts amendments to protocols, consent forms, and associated study documents, based on requests and suggestions by the PI and Program Managers, and submits these for IRB approval;

* Contributes to protocol recommendations and communicates these to the clinical research team;

* Monitors and reports adverse events as required by institutional/federal regulations;

* Contributes to preparation of protocols, reports, and regulatory submissions for submission to the IRB, the Gates Foundation, NIH, and MGH subcommittees (Clinical Trials Pharmacy, TCRC), as relevant.

1. Data Management - With minimal supervision from the PI and/or Program Managers, assists with coordination of all research data (participant data, analyzed data, etc.) while following regulatory guidelines such as HIPAA.

* Prepares data for analysis and data entry;

* Conducts library and internet searches;

* Maintains research data, subject files, and study database entries;

* Uses software programs to generate graphs and reports;

* Assists with formal audits of data, protocols and INDs.

1. General Office & Laboratory Support:

* Orders clinical research laboratory/office supplies and assists with managing inventories;

* Contributes to creation and maintenance of SOPs, training documents, and workflows;

* Participates in conference calls and other meetings as directed;

* Provides support to Program and Administrative Managers;

* Assumes additional administrative and clinical research tasks, as needed.

EDUCATION:

• Bachelor's degree required.

EXPERIENCE:

• New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above.
• Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position.

SUPERVISORY RESPONSIBILITY (if applicable):

• A Clinical Research Coordinator I does not have any supervisory responsibility.
• A Clinical Research Coordinator II may assist with the training and orientation of new staff members.

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED

• Ability to demonstrate professionalism, compassion, and respect for study participants' rights and needs;
• Extraordinary attention to detail, ability to work carefully and efficiently with minimal supervision;
• High level of proficiency with Microsoft Excel, Word, PowerPoint and computer data entry skills required;
• Experience with medical chart reviews and electronic medical records is an advantage. Knowledge of database management strongly preferred;
• Ability to interpret acceptability of data;
• Good judgment and problem solving skills, ability to handle multiple tasks, people and schedules
• Excellent oral and written communication skills in English
• Ability to adapt to changing priorities
• Clear verbal and written communication
• Ability to problem solve independently
• Ability to work both independently and as part of a busy, multidisciplinary team, interacting with diverse individuals at multiple levels within the research and clinical group
• Work hour flexibility. Some visits start early in the morning (7 am) and there may be intermittent work after normal business hours including weekends.

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.