Clinical Research Coordinator

GENERAL SUMMARY/ OVERVIEW STATEMENT:

Dr. Patrick Catalano is a Professor in Residence in the Reproductive Endocrine Unit at MGH. The REU is a National Center for Translational Research in Reproduction and Infertility, funded by the National Institute of Child Health and Development (NIH). The Unit is also a recipient of a Gates Foundation Grand Challenge Award and multiple NIH R01 grants.

Under the direction of Dr. Patrick Catalano and the Program Managers for the Reproductive Endocrine Unit, the Clinical Research Coordinator will assist with studies for which Dr. Catalano is the Principal Investigator (PI). The CRC will work on studies examining the metabolic and physiologic adaptations to pregnancy. These studies employ skinfold measures, indirect calorimetry to estimate energy expenditure, body composition using Bod Pod devices, intravenous infusions of stable isotopes, nutrition and exercise programs. Our studies often include assessment of neonates using anthropometric measures and neonatal body composition.

The CRC is expected to collaborate closely with the REU (Sr) Program Manager(s), the PI, and other members of the REU's clinical research team. Typical responsibilities include the following activities: screening and recruitment of individuals for study participation, ensuring protocol requirements are met, preparing and submitting protocol amendments and updates to the Institutional Review Board (IRB), collecting data for input into research databases, handling biological samples, phlebotomy, and maintaining and updating regulatory documentation for compliance.

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 multiple clinical research studies and data projects, with responsibilities including:

1. Protocol Execution

* With minimal supervision from the PI and REU Program Managers, implements study recruitment strategies and procedures.

• Many of the studies are conducted in the MGH Translational & Clinical Research Center (TCRC

* Recruitment of participants from the antenatal obstetrical clinics and/or postpartum unit.

* Perform physiologic measures in conjunction with the research RNs in the Clinical Research Unit.

* Our studies employ skinfold measures, indirect calorimetry to estimate energy expenditure, body composition using Bod Pod devices, intravenous infusions of stable isotopes, nutrition and exercise programs. Our studies often include assessment of neonates using anthropometric measures and neonatal body composition (Pea Pod).

* iScreening of potential subjects, reviews medical records to verify subject inclusion/exclusion criteria;

• Obtaining informed consent when appropriate;
• Interacting with study subjects during all study visits, provides information/education about study procedures, and aids with all study procedures such as: phlebotomy, completion of study materials, and remote enrollment;
• Performing biological sample duties: label making, record maintenance, processing, packaging and shipment/receipt;
• Coordinating and interacting with clinical staff (research nurses, etc) as required by protocol;
• Maintaining study specific documents and enrollment tables;
• Contributing 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 Manager, and submits these for IRB approval;

* Contributes to protocol recommendations and communicates these with the Program Team;

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

* Contributes to preparation of protocols, reports and regulatory submissions for submission to both internal and external groups (e.g. TCRC, NIH)

1. Data Management




• With minimal supervision from the PI and/or Program Manager, 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 and protocols.

* Builds and maintains REDCap projects

* Intermediate computer proficiency (e.g. able to troubleshoot error messages, computer set up, organize files for efficient workflow

* Intermediate Excel skills

* Intermediate Power Point proficiency

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 REU Program and Administrative Managers, as needed.

* 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.