Under the general direction of the Program Manager for the Reproductive Endocrine Unit, the Clinical Research Coordinator II will assist with multiple research protocols in the Unit's portfolio. The CRC II will work on studies of infertility and reproductive endocrinology. He/she is expected to collaborate closely with the Program Manager, PI's, and other members of the clinical research team. Typical responsibilities include the following activities: screening and recruitment of individuals for study participation, ensuring protocol requirements are met, collecting data for input into the research databases, handling biological samples, phlebotomy and maintaining and updating regulatory documentation for compliance.
Interested candidates should submit a cover letter and three references with his/her application.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Coordinates multiple (5 to 10) concurrent clinical research studies, with responsibilities including:
Protocol Execution - With minimal supervision from the REU Program Manager, implements study recruitment strategies and procedures.
Screens potential subjects, reviews medical records to verify subject inclusion/exclusion criteria;
Obtains informed consent where appropriate;
Interacts 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;
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.
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 and INDs;
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 PI and Program Manager;
Monitors and reports adverse events as required by institutional/federal regulations;
Contributes to preparation of protocols, reports and regulatory submissions for submission to FDA, NIH, IRB, and MGH subcommittees (Clinical Trials Pharmacy, TCRC)
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, protocols and INDs.
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.
Bachelor's degree (required);
1 to 2 years of directly related experience.
Experience with genetics investigation and translational research STRONGLY preferred
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
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. 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
Ability to demonstrate professionalism, compassion and respect for study participants' rights and needs
Excellent oral and written communication skills in English
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.
Research laboratory 40 hours per week - Some flexibility in schedule