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 an investment from the Amplify Fund of MGB's Innovation Division. Dr. Seminara, Unit Chief, is PI on an NIH Merit Award (R37), which provides 10 years of funding for her translational studies. The research program encompasses human genetics and translational research studies that address both rare and common forms of reproductive dysfunction.

The ideal candidate for this position is energetic, enthusiastic, proactive, and deadline-driven. The Clinical Research Specialist will be a daily "point person" for the team's clinical research coordinators, helping maintain the best possible team environment. They will be responsible for fostering and enhancing inter-team collaboration, serving as a source of knowledge and expertise for the more junior staff.

The Clinical Research Specialist will focus on ensuring that recruitment of research participants across the REU's research program proceeds on schedule and that daily study operations (research visits and associated tasks) run smoothly. They will also spend a significant amount of time overseeing and prioritizing the activity of clinical research coordinators, informing work flow and assignments of personnel across multiple protocols to ensure the most efficient and effective use of resources. This will require the ability to respond quickly to unexpected changes and challenges with appropriate speed but also with sophistication of thought. Above all else, this requires appropriate identification of situations where the Program Manager and/or Sr Program Manager need to become involved in designing and implementing solutions.

The Clinical Research Specialist will establish and maintain systems to monitor the REU's recruitment approaches and techniques, increase visibility of the REU's research studies within and beyond MGH, identify new opportunities to recruit relevant participants, and, when indicated by metrics data, improving recruitment processes. The Clinical Research Specialist will develop metrics and monitor data to ensure that recruitment approaches and other core team functions are succeeding.

The Clinical Research Specialist will represent the REU in relating to colleagues and collaborators within MGH (including Clinical Trials Pharmacy, the Translational and Clinical Research Center, and Radiology) and beyond.

The Clinical Research Specialist coordinates and oversees the implementation of recruitment and other operations activities for multiple, concurrent clinical research studies/trials, with responsibilities including:

1. Program Communication:

* Strategize with staff when problems arise and offer potential solutions.

* Ensure uniform application of regulatory requirements across all REU programs, as instructed by Program Managers.

* Stay abreast of the changing research landscape at MGB by attending appropriate meetings/councils/etc.

* Communicate with internal regulatory agencies such as the IRB and the DSMB.

* Help to coordinate new protocol submissions, response to review, and continuing review with the IRB.

* Help to draft new protocol submissions, response to review and continuing reviews.

* Ensure compliance with MGH, IRB, NIH, FDA regulatory requirements and research goals when drafting regulatory materials.

* Communicate with various hospital staff.

* Communicate with non-Reproductive Endocrine Unit investigators.

2. Protocol Execution and Design:

* Recruit study subjects;

* Obtain informed consent, when permissible;

* Assist in screening participants for study eligibility;

* Review screening data;

* Report noteworthy participant data to the Principal Investigator;

* Coordinate with clinical staff (nurses, MDs);

* Aid with conduct/completion of study procedures;

* Phlebotomy and vitals signs collection

* Basic blood sample processing

* Perform project related tasks. These include (but are not limited to) cross checking of samples and consents, data entry, label making, blood sample processing, sample packaging and sample mailing.

* Maintain study documents and enrollment tables;

* Perform data analysis;

* Ensure that all study staff follow GCP procedures and adhere to safe practices in the conduct of clinical research.

3. Data Management:

* Obtains and organizes patient data from medical records, physicians, etc., using HIPAA/GCP guidelines:

* Data entry and analysis;

* Conduct library and internet searches;

* Use software programs to generate graphs and reports;

* Contribute to development and maintenance of research data, subject files, and study databases;

* Assist with formal audits of protocol/INDs.

4. Regulatory Compliance: Develops and maintains protocol-specific systems for Quality Assurance/Quality Control, IRB amendment and reviews, and external regulatory submissions. These tasks include:

* Update and verify accuracy of study forms per protocol;

* Monitor and report adverse events as required by institutional/federal regulations;

* Assist in maintain regulatory binders for protocols and INDs;

* Facilitate integration of regulatory issues to ensure safe practice;

* Develop and maintain systems for QA/QC;

* Contribute protocol recommendations;

* Prepare and submit protocols, reports and regulatory submissions as required by FDA, NIH, IRB, MGH subcommittees (Clinical Trials Pharmacy, TCRC)

5. General Support:

* Training and orienting new study staff;

* Execute all program operations, including:

* Draft or review SOPs, training documents, and workflows.

* Ensure that SOPs are followed.

* Enforce uniform standards for data management across the Unit.

* Orders clinical research laboratory supplies and oversees inventories;

* Oversees bio-tissue sample processing, per study protocol;

* Maintains sample collection repository; receives, ships and stores specimens, as required by protocol;

* Participate in conference calls and other meetings as directed;

* Perform other duties and responsibilities at the supervisor's request.

* BS/BA or Equivalent

* 3-5 years of progressively more sophisticated clinical research experience (required), preferably with research studies that involve significant participant engagement and effort.

* 1+ years of functional oversight (even if unofficial) of at least junior clinical research staff member

* Dynamic, energetic, constructive personality that inspires positive morale and team cohesion. Able to motivate a team of clinical research coordinators to meet recruitment goals within needed timeframes.

* Able and willing to proactively provide clear, timely, respectful feedback to members of the team.

* Professional, respectful, and compassionate in relating to both research participants and to colleagues and collaborators.

* Ability to prioritize their individual work and the work of the team with nuance, such that the most important programmatic objectives are met on schedule. Exceptional time-management skills.

• Good judgment and problem-solving skills, ability to simultaneously coordinate multiple tasks, people and schedules;
• 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;

* Past and/or current certification in human subjects research (CITI or equivalent) and has strong GCP knowledge.

• Extraordinary attention to detail and the ability to work carefully and efficiently with minimal supervision.

* Excellent oral and written communication skills in English.

• 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 required.

* Familiarity with at least one electronic data capture (EDC) system is required (e.g., REDCap)

• MUST have hands-on experience relating to human research subjects in person.
• Phlebotomy training and experience is preferred.

• Knowledge of database management strongly preferred;
• Ability and willingness to learn new research and administrative skills;

Every effort will be made to keep to 40 working hours per week. However, the work hours of the Clinical Research Specialist position are defined by the nature of the work itself. Therefore, the Clinical Research Specialist, at times, may be called upon to come in early, stay late, or work on weekends. For example, evening hours may be needed to follow-up with study participants or conduct recruitment activities. Some clinical research visits start early in the day or occur on weekends.

Task-associated oversight of 1-4 clinical research coordinators is part of this role. May be asked to assist the Sr. Program Manager with personnel and project management, as needed.