Clinical Trials Coord-Unlic.

Stamford Health•Stamford, CT

12d•Onsite

About The Position

This role is responsible for reviewing institutional review board approved protocols and related documents prior to study activation and patient enrollment. The position involves screening and identifying potential subjects by reviewing patient charts and other records. The Clinical Trials Coordinator attends investigator meetings and participates in pre-study and initiation meetings. Key responsibilities include collecting and maintaining accurate patient data for Sponsor submission, coordinating specimen collection and shipments, and communicating study objectives to relevant hospital units. The role also involves facilitating communication between the Principal Investigator and the Sponsor, educating staff about investigational products, and providing emotional and educational support to patients and their families. Obtaining informed consent, maintaining drug supplies, assisting with protocol evaluation, and ensuring speedy patient enrollment are also critical functions. The position requires submitting new protocols and amendments to the IRB, training less experienced team members, and adhering to Good Clinical Practices, hospital policies, and regulatory guidelines such as AAHRPP, HIPPA, and FDA guidelines.

Requirements

Practical research experience required (in a hospital setting) with a minimum of 3 years experience in the field.
Experience in protocol assessment and implementation.
Good organizational skills, detail-oriented, people-oriented, self-confident, flexible and adaptable to change, with time management skills.
High energy level professional.
Knowledge of protocols and its process.
Must be able to relate cooperatively and constructively with personnel and co-workers.
Experience with personal computers and basic software applications, including word processing, scheduling and contact database, email, web browsing, hospital records, other database software, and office equipment.
Ability to communicate effectively in English, both verbally and in writing, and to maintain confidentiality of sensitive information.
Maintains knowledge of, and follows, relevant departmental and Stamford Hospital policies and procedures.
Participates in mandated Stamford Hospital / Office of Research education / training initiatives.

Nice To Haves

RN preferred.
Clinical research certification (such as CCRC, CCRP, CRA, IATA) preferred.
If not yet certified, expected certification within 6-12 months of hire date.
Human Research Subject Protection and Good Clinical Practice Certification
OSHA training for handling hazardous biologic and chemical materials

Responsibilities

Review institutional review board approved protocol and protocol documents prior to study activation and patient enrollment.
Review patient charts, database records, and other sources to screen and identify potential subjects for inclusion in a study.
Attend and participate in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate.
Collect and maintain accurate patient data for submission to Sponsor, maintaining proper patient records and coordinating the collection and shipments of specimens as required by protocol.
Communicate study objectives and procedures to all relevant hospital units involved with the study, including the establishment of good rapport with the Principal Investigator and providing him/her with the required assistance.
Communicate with the Sponsor or its representatives, schedule and facilitate study Monitor visits, and facilitate communication between Principal Investigator and Sponsor or Sponsor's representatives.
Educate physicians, nurses, and ancillary staff regarding investigational product, trial activities, and requirements.
Meet with potential subjects and their families to explain trial and treatment plan, and provide emotional and educational support.
Interact with patients and families to ensure compliance with the protocol.
Obtain written informed consent for subject to participate in trial prior to performing any study-related procedures.
Maintain drug supplies as directed by the study protocol.
Assist the Director and Manager with protocol evaluation and feasibility.
Responsible for speedy and adequate patient enrollment in all assigned studies.
Submit new protocols to IRB and verify that the proper document was received.
Submit amendments of protocols to IRB and verify that the required corrections were inserted following the established procedures.
Train less experienced team members.
Utilize Good Clinical Practices in the conduct of clinical trials as per established protocol.
Follow Stamford Hospital’s Standard Operating Procedures, AAHRPP, HIPPA, and FDA guidelines for clinical research, keep updated with those procedures and/or guidelines, and comply with finance compliance policies and procedures.