Clinical Research Coordinator I

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.

2. 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.

3. 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.

4. 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, preferably in a science field

Can this role accept experience in lieu of a degree?
No

Licenses and Credentials

Experience
Some relevant research project work 0-1 year preferred

Knowledge, Skills and Abilities

* 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 results;
* Good judgment and problem solving skills, ability to handle multiple tasks, people and schedules
* Excellent oral and written communication skills in English
* Attention to detail
* 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.