Site Management Administrator

1 week ago

Melbourne, Victoria, Australia ICON Full time

Role
:
Sit
e Ma
na
gem
ent Ad
ministr
ator
ICON plc is a world-leading healthcare intelligence and clinical research organisation.

From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.


With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.


Our people are our greatest strength, are at the core of our culture, and the driving force behind our success.

ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The R
ole:

To b
e su
cc
es
sful in the rol
e, yo
u will hav
e:

  • Assists in identifying study sites by performing site feasibility and recruitment tasks, e.g., completing, disseminating and reviewing responses to site recruitment questionnaires.
  • Completes essential document collection and review throughout the study lifecycle inclusive of site activation. Organizes and maintains site clinical trial master file (TMF) documents.
  • Sets up and maintains siterelated data in applicable clinical systems according to procedures and guidelines.
  • Acts as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies and conducting offsite central monitoring visits/contacts (prestudy, initiation, monitoring and close out visits). Escalates issues and risks as needed.
  • Ensure timely and complete data entry by site. Perform data review inclusive of site level data review, query resolution, facilitate database closure and freezing procedures as per study plans.
  • Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.
  • Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study specific processes, local regulatory requirements.
  • Performs a variety of routine essential document collection, review, negotiation, to ensure successful site activation and maintenance and close out tasks under general supervision.
  • Performs recruitment of study sites, ensuring activities, documents and all other clinical data are accurately tracked and documented for the project lifecycle. Escalates issues as needed.
  • Complete submissions and notifications to regulatory authorities, ethics committee and other bodies.
  • May serve as a patient management associate (conduct patient interviews, answer questions, follow up on issues).
  • Performs and documents clinical data review and query creation, query resolution, offsite central monitoring contacts/visits and site management communications as outlined in the study plans (and/or other processes)
  • Sets up and maintains study documentation in applicable systems, e.g., clinical trial management system (CTMS), TMF system, applicable site/sponsor systems according to project protocol, applicable SOPs and project plans.
  • Benefi_t_s of _W_orking in I_CO_N:_
  • Our su_c_cess _d_epends on t_h_e _k_nowl_e_dg_e_, ca_p_a_bili_t_i_es _a_nd quality of our peopl_e_. That's why _w_e are _c_om_m_itt_e_d _t_o develo_p_ing _o_ur _e_mp_l_oy_e_es in a c_o_ntinu_o_us _l_earning _c_ulture one where we challen_g_e _y_ou with en_g_a_gi_n_g work and where _e_v_ery ex_p_eri_e_nc_e _a_dds _t_o _y_o_u_r profe_s_sional d_e_v_elopm_e_nt._
  • At IC_O_N, _o_ur focus is to _p_r_ovide you with a compr_e_hensive and compe_t_i_tive to_t_al r_e_wa_r_d pa_c_kage that compris_e_s, n_o_t only an _e_xcellent l_e_v_el of base pay, but also a w_i_de _r_ange of v_a_ri_a_ble pay and r_e_cogn_i_tion progra_m_s. _I_n additi_o_n, _o_ur best in _c_la_s_s emplo_y_ee benefits, s_u_ppo_r_tive _p_olic_i_es _a_nd _w_ell_b_eing initi_a_tives are tailored to s_u_pport y_o_u a_n_d your _f_amily at a_l_l sta_g_es of your _c_ar_e_er b_o_th now, and into the _f_uture._
  • IC_O_N, incl_u_di_ng _s_ubsidia_ri_e_s_, is an _e_qu_a_l opportunity and inclu_s_ive emplo_y_er a_n_d is commi_t_t_e_d _t_o pro_v_iding a workpla_c_e fr_e_e of discrim_in_ation and ha_r_ass_m_en_t_. All qualified _a_pp_l_icants will r_e_c_eive equal _co_nsid_e_r_ation _f_or employ_m_ent witho_u_t r_e_ga_r_d _t_o ra_c_e, co_l_or, r_e_ligion, _s_e_x_, _s_exual orient_a_tion, ge_n_der i_d_entity, natio_n_al orig_i_n, disabil_i_ty or _p_rote_c_t_e_d vet_e_ran _s_tatus._
LI-AP2

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